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National Institutes of HealthOffice of the Director

NIH Consensus Statement

Diagnosis and Management ofDental Caries Throughout Life

Volume 18, Number 1March 26–28, 2001

About the NIH Consensus Development ProgramNIH Consensus Development Conferences are convened to evaluateavailable scientific information and resolve safety and efficacy issuesrelated to a biomedical technology. The resultant NIH ConsensusStatements are intended to advance understanding of the technology orissue in question and to be useful to health professionals and the public.

NIH Consensus Statements are prepared by nonadvocate, non-Federalpanels of experts, based on (1) presentations by investigators working inareas relevant to the consensus questions during a 2-day public session,(2) questions and statements from conference attendees during opendiscussion periods that are part of the public session, and (3) closeddeliberations by the panel during the remainder of the second day andmorning of the third.

This statement is an independent report of the consensus panel and is nota policy statement of the NIH or the Federal Government. The statementreflects the panel’s assessment of medical knowledge available at thetime the statement was written. Thus, it provides a “snapshot in time”of the state of knowledge of the conference topic. When reading thestatement, keep in mind that new knowledge is inevitably accumulatingthrough medical research.

Reference InformationFor making bibliographic reference to this consensus statement, it isrecommended that the following format be used, with or withoutsource abbreviations, but without authorship attribution:

Diagnosis and Management of Dental Caries Throughout Life.NIH Consensus Statement 2001 March 26–28; 18(1) 1–30.

Publications Ordering InformationNIH Consensus Statements, NIH Technology Assessment Statements,and related materials are available by writing to the NIH ConsensusProgram Information Center, P.O. Box 2577, Kensington, MD 20891;by calling toll-free 1-888-NIH-CONSENSUS (888-644-2667); or byvisiting the NIH Consensus Development Program home page athttp://consensus.nih.gov on the World Wide Web.

The Evidence Report prepared for this conference by the Agencyfor Healthcare Research and Quality is available on the Web viahttp://www.ahrq.gov/clinic/epcix.htm. Printed copies may beordered from the AHRQ Publications Clearinghouse by calling1-800-358-9295. Requestors should ask for AHRQ PublicationNo. 01-E056. An extensive bibliography prepared by theNational Library of Medicine is available on the Web athttp://www.nlm.nih.gov/pubs/cbm/dental_caries.html

NIH Consensus Statement

National Institutes of HealthOffice of the Director

Diagnosis and Management ofDental Caries Throughout Life

Volume 18, Number 1March 26–28, 2001

Date of original release:March 28, 2001

Disclosure Statement

All of the panelists who participated in this conferenceand contributed to the writing of this consensus statementwere identified as having no financial or scientific conflict ofinterest, and all signed conflict of interest forms attesting tothis fact. Unlike the expert speakers who present scientificdata at the conference, the individuals invited to participateon NIH consensus panels are selected specifically becausethey are not professionally identified with advocacy positionswith respect to the conference topic or with research thatcould be used to answer any of the conference questions.

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Abstract

Objective

To provide health care providers, patients, and the generalpublic with a responsible assessment of currently availabledata regarding the diagnosis and management of dentalcaries throughout life.

Participants

A non-Federal, non-advocate, 13-member panel repre-senting the fields of dentistry, epidemiology, genetics,medicine, oral biology, oral radiology, pathology, perio-dontics, public health, statistics, surgery, and includinga public representative. In addition, 31 experts in thesesame fields presented data to the panel and to a con-ference audience of approximately 700.

Evidence

Presentations by experts; a systematic review of the dentalresearch literature provided by the Agency for HealthcareResearch and Quality; and an extensive bibliography ofdental caries research papers, prepared by the NationalLibrary of Medicine. Scientific evidence was given prece-dence over clinical anecdotal experience.

Consensus Process

Answering predefined questions, the panel drafted a state-ment based on the scientific evidence presented in openforum and the scientific literature. The draft statement wasread in its entirety on the final day of the conference andcirculated to the experts and the audience for comment.The panel then met in executive session to consider thesecomments and released a revised statement at the end ofthe conference. The statement was made available on theWorld Wide Web at http://consensus.nih.gov immediatelyafter the conference. This statement is an independentreport of the panel and is not a policy statement of theNIH or the Federal Government.

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Conclusions

This Consensus Development Conference, the firstsponsored by the NIH on dental caries, provided anexcellent venue to describe the great success thathas been achieved in reducing caries prevalence. Moreimportantly, it provided a public forum to review both thestrengths and weaknesses of current dental caries researchand clinical procedures. Effective preventive practices,such as the use of fluoride, sugarless products, and dentalsealants were reconfirmed and clinical studies to identifymore conservative but more effective nonsurgical andsurgical approaches are to be applauded. However, itwas evident that current diagnostic practices are inade-quate to achieve the next level of caries management inwhich noncavitated lesions are identified early so thatthey can be managed by nonsurgical methods. Somenew and sensitive diagnostic approaches were presentedto the panel, but concern was raised about the use of histo-logical confirmation of caries presence as an appropriate goldstandard. The resolution of these issues requires that surrogatemarkers, validated by histological confirmation, be developed.Once these surrogate markers of dental caries activity arevalidated, rapid advances in our understanding of the cariesprocess are certain to follow.

In spite of optimism about the future, the panel was disap-pointed in the overall quality of the clinical data set that itreviewed. Far too many studies used weak research designsor were small or poorly described, and consequently hadquestionable validity. There was a clear impression thatclinical caries research is underfunded, if not undervalued.Moreover, incomplete information on the natural history ofdental caries, the inability to accurately identify early lesionsand/or lesions that are actively progressing, and the absenceof objective diagnostic methods are troubling. Several sys-tematic reviews of the literature presented at the ConsensusDevelopment Conference concluded that the majority of the

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studies were inadequate, and it is clear that a majorinvestment of research and training funds is required toseize the current opportunities.

This is not to say that the diagnostic, preventive, andtreatment techniques currently used do not work, butrather that earlier studies to support their efficacy donot meet current scientific standards. Indeed, giventhe dramatic improvements in reducing dental cariesprevalence in the past 30 years, both consumers andhealth professionals should not depart from the prac-tices which are likely to have contributed to this oralhealth improvement, including the use of a variety offluoride products, dietary modification, pit and fissuresealant, improved oral hygiene, and regular professionalcare. In addition, pending new data, clinicians shouldapply both preventive and therapeutic interventionsin the manner in which they have been studied. Whensolid confirmation of the effectiveness of promisingnew diagnostic techniques, nonsurgical treatmentsof noncavitated lesions, and conservative surgicalinterventions for cavitated lesions are obtained,dental health professionals and the public shouldembrace them rapidly in anticipation of attainingstill higher levels of oral health. None of theseanticipated advances will be achieved, however,in the absence of a progressive, third-party pay-ment system that acknowledges its responsibilityto compensate providers adequately to ensurethat the next generation of conservative therapycan be enjoyed by the American people.

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IntroductionThere has been remarkable progress in the reduction ofdental caries (tooth decay) in the United States over thepast 30 years. The existence of children with no dentalcaries, a rarity in the past, is no longer unusual. The useof fluoride in public water supplies, in toothpaste, and inprofessional dental products, improved oral hygiene, andincreased access to dental care have played major rolesin this dramatic improvement. Nevertheless, dental cariesremains a significant problem. Nearly 20 percent of childrenbetween the ages of 2 and 4 have detectable caries, andby the age of 17 almost 80 percent of young people havehad a cavity — a late manifestation of dental caries infection.In addition, more than two-thirds of adults age 35 to 44years have lost at least one permanent tooth due to dentalcaries, and older adults suffer from the problem of rootcaries. Moreover, there remain large segments of thepopulation in which the disease remains a major pro-blem. These health disparities, detailed in the SurgeonGeneral’s Report on Oral Health, tend to be clusteredin minority children, the economically underprivileged,older persons, the chronically ill, and institutionalizedpersons — the very populations with the lowest accessto dental care.

It should be noted that dental caries is an infectious,communicable disease resulting in destruction of toothstructure by acid-forming bacteria found in dental plaque,an intraoral biofilm, in the presence of sugar. The infectionresults in loss of tooth minerals that begins on the outersurface of the tooth and can progress through the dentinto the pulp, ultimately compromising the vitality of thetooth. During the past few decades, changes have beenobserved not only in the prevalence of dental caries, butalso in the distribution and pattern of the disease in thepopulation. Specifically, it has been observed that therelative distribution of dental caries on tooth surfaceshas changed, and the rate of lesion progression throughthe teeth is relatively slow for most people. These changes

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have important implications for diagnosis and manage-ment of incipient lesions, predicting caries risk, andconducting effective disease prevention and man-agement programs for individuals and populations.

In order to make continued progress in eliminating thiscommon disease, new strategies will be required toprovide enhanced access for those who suffer dispro-portionately from the disease; to provide improveddetection, risk assessment, and diagnosis; and tocreate improved methods to arrest or reverse thenoncavitated lesion while improving surgical manage-ment of the cavitated lesion.

In an effort to optimize the identification of improvedcaries diagnostic, prevention, and treatment strategies,and to assess the quality of the data on existing diagnosticand treatment paradigms, the National Institutes of Healthcommissioned a Consensus Development Conference(CDC) on Diagnosis and Management of Dental CariesThroughout Life. The CDC explored these issues in apublic forum on March 26–28, 2001, so that health careproviders and the general public can make informeddecisions about this important public health issue.

During the first day-and-a-half of the conference, expertspresented the latest dental caries research findings to anindependent, non-Federal Consensus Development Panel.After weighing the scientific evidence the panel wrote adraft statement that was presented to the audience onthe third day. The consensus statement addressed thefollowing key questions:

• What are the best methods for detecting earlyand advanced dental caries (validity and feasibilityof traditional methods; validity and feasibility ofemerging methods)?

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• What are the best indicators for an increased risk ofdental caries?

• What are the best methods available for the primaryprevention of dental caries initiation throughout life?

• What are the best treatments available for reversingor arresting the progression of early dental caries?

• How should clinical decisions regarding preventionand/or treatment be affected by detection methodsand risk assessment?

• What are promising new research directions forthe prevention, diagnosis, and treatment ofdental caries?

This conference was sponsored by the National Instituteof Dental and Craniofacial Research (NIDCR) and theNIH Office of Medical Applications of Research. Thecosponsors included the National Institute on Agingand the U.S. Food and Drug Administration.

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What Are the Best Methods forDetecting Early and Advanced DentalCaries (Validity and Feasibility ofTraditional Methods; Validity andFeasibility of Emerging Methods)?Observations and studies during the past two decadeshave indicated that diagnostic and treatment paradigmsmay differ significantly for large, cavitated lesions versusearly, small lesions and demineralized areas on tooth sur-faces. The essential anatomic-pathophysiologic problemis that the carious lesion occurs within a small, highlymineralized structure following penetration through thestructure’s surface in a manner which may be difficult todetect using current methods. Additionally, carious lesionsoccur in a variety of anatomic locations, often adjacent toexisting restorations, and have unique aspects of config-uration and rate of spread. These differences make itunlikely that any one diagnostic modality will have ade-quate sensitivity and specificity of detection for all sites.The application of multiple diagnostic tests to the individualpatient increases the overall efficacy of caries diagnosis.Existing diagnostic modalities require stronger validation,and new modalities with appropriate sensitivities and spe-cificities for different caries sites, caries severities, anddegrees of caries activity are needed.

A systematic review, based on predefined criteria, con-cluded that studies of reliability and reproducibility ofexisting diagnostic modalities, which included visual-tactile,radiographic, and electrical conductance examinations,were not strong. The most significant problems with thesestudies were weak study designs; variability of examinercalibration; differences in criteria for lesions; lack of stand-ards for histological validation; lack of adequate numbersof studies on several modalities and types of caries; andthe sensitivity and specificity of caries detection. Also,given the acceptance criteria of the systematic review,which excluded all studies without histologic confirma-tion, the results regarding the validities of the examinedmodalities were ambiguous.

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A number of studies excluded by the systematic reviewwere also addressed. The use of sharp explorers in thedetection of primary occlusal caries appears to add littlediagnostic information to other modalities and may bedetrimental. Studies employing receiver operating char-acteristic (ROC) analyses have shown radiology to haveacceptable diagnostic efficacy in detecting larger cavi-tated lesions in numerous in vitro and in vivo studies.There was agreement that the literature is weak in theareas of diagnosis of caries on root surfaces and adja-cent to existing restorations. The problems of assessingthe microbiological load of demineralized dentin adjacentto or beneath existing restorations, and differentiatingbetween residual and secondary caries, are substantialand important. Digitally acquired and post-processedimages have great potential in the detection of noncavitatedcaries and in the diagnosis of secondary caries. Promisingnew diagnostic techniques are emerging, including fiber-optic transillumination and light and laser fluorescence.These new modalities and developing digital imagingsystems require robust laboratory and clinical evaluation.

Existing diagnostic modalities appear to have satisfactorysensitivity and specificity in diagnosing substantial, cavitated,dental caries; specifically radiographic methods are essentialin diagnosing interproximal carious lesions. However, thesemodalities do not appear to have sufficient sensitivity orspecificity to efficaciously diagnose noncavitating caries,root surface caries, or secondary caries. There is currentlyno diagnostic modality which can differentiate betweenmicrobiologically active caries and demineralized dentinwithout caries activity beneath a restoration. This is a criticalweakness in view of the significant percentage of restora-tions inserted to replace existing restorations. The needfor the identification and clinical staging of the presence,activity, and severity of dental caries is of paramountimportance in the deployment of treatment strategiesthat employ increasingly important nonsurgical modalities,such as fluoride, antimicrobials, sealants, and no treatment.Some diagnostic modalities are currently in various stagesof development and testing; these modalities will need tobe evaluated, using rigorously controlled clinical trials. Suchstudies will promote true staging of carious lesions, basedon highly sensitive and specific diagnoses, followed byappropriate, linked, treatment-planning decision algorithms.

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What Are the Best Indicators for anIncreased Risk of Dental Caries?Recent decades have seen a remarkable decline in dentalcaries in the United States. The level of caries incidence,however, is not evenly distributed in the population. Overall,20 percent of the population bears at least 60 percent of thecaries burden while fewer than 5 percent of adults are caries-free. Thus, effective dentistry requires early identification ofchildren at high risk for extensive caries so that they mayreceive early and intense preventive intervention, as wellas those at low risk so as to reduce unnecessary care andassociated expenditures. Caries incidence changes in adult-hood and in geriatric populations, and risk and risk indicatorsmay differ due to changes in host and environmental charac-teristics. Accurate caries prognosis throughout the life span,however, can support an appropriate, individualized level ofcare for each patient and a more effective use of health careresources for the individual and for the population. In addition,as dentistry moves towards earlier detection of lesions and amore preventive rather than restorative orientation, good riskassessment will be essential for improving the predictivevalues of new screening and diagnostic methods bypreselecting at-risk subpopulations.

Numerous risk indicators, that is, characteristics or measure-ments that assist in the prediction of caries, whether or notthey are involved in caries causation, have been suggestedfor children. Unfortunately, more of the supportive datacome from cross-sectional correlations with accumulatedcaries experience than from prospective, protocol-basedincidence studies. The prospective studies employeddifferent combinations of potential predictors in a varietyof populations, varied considerably in sample size andquality, and have not produced a broadly applicable indexor set of criteria for risk assessment. More and higher-qualitycomprehensive, longitudinal, multifactor studies of implicatedrisk indicators are needed to obtain firm support for theirassociations with caries incidence, to clarify the strengthsof these associations in differing populations, and to reveal

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the extent to which the risk indicators provide independentas opposed to redundant information. In addition, althoughthe nature of the disease process suggests that many of theproposed indicators may well be appropriate throughoutlife, validation studies in adult populations are largely absentor incomplete. Nevertheless, in practice there are severalreadily determinable indicators that together provide helpfulguidance when dealing with otherwise healthy persons andsome well-validated medical or disability conditions thatplace individuals at heightened caries risk.

Thus far, the most consistent predictor of caries risk inchildren is past caries experience. In addition, there isevidence of matrilineal transmission of mutans streptococciin early childhood. Hence, the presence of caries in themother and siblings increases risks for the child.

Regular brushing of tooth surfaces using a fluoride-containingdentifrice, reduces caries risk. Conversely, inadequate exposureto fluoride confers increased risk. Conditions that compromisethe long-term maintenance of good oral hygiene are alsopositively associated with caries risk. These include certainillnesses, physical and mental disabilities, and the presenceof existing restorations or oral appliances.

Fermentable carbohydrate consumption fuels acidformation and demineralization and is associated withcaries, particularly in the absence of fluoride. The amount,consistency, and frequency of consumption determinethe degree of exposure. Long-term regular doses ofmedications containing glucose, fructose, or sucrosemay also contribute to caries risk.

Medical conditions such as Sjögren’s syndrome, phar-macological agents with xerostomic side effects, andtherapeutic radiation to the head and neck, lower salivaryflow rate to pathological levels and dramatically elevate apatient’s risk of caries. This suggests that normal salivaryflow rate is protective against caries. Some studies indicatethat low buffering capacity, low salivary IgA, and low salivarycalcium and phosphate are weakly linked to increasedcaries as well.

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Mutans streptococci is an established etiologic agent forcaries, and its presence clearly indicates the potential forcariogenic activity. However, its presence alone is no morethan weakly predictive of clinical caries activity.

While some of the risk indicators known for children maywell be applicable across all ages, some may differ acrossages in the way they act or in their degrees of importance,while other risk indicators must be considered distinctivefor adult and elderly populations. Thus, the inability to main-tain good oral hygiene and xerostomia are risk factors ofspecial significance among the elderly, and gingival reces-sion uniquely increases the risk of root caries in elderlypopulations by exposing previously protected rootsurfaces to cariogenesis.

Low indices of socioeconomic status (SES) have beenassociated with elevations in caries, although the extentto which this indicator may simply reflect previous corre-lates is unknown. Low SES is also associated with reducedaccess to care, reduced oral health aspirations, low self-efficacy, and health behaviors that may enhance caries risk.

Caries is an etiologically complex disease process. It islikely that numerous microbial, genetic, immunological,behavioral, and environmental contributors to risk are atplay in determining the occurrence and severity of clinicaldisease. Assessment tools based on a single risk indicatorare therefore unlikely to accurately discriminate betweenthose at high and low risk. Multiple indicators, combinedon an appropriate scale and accounting for possible inter-actions, will certainly be required.

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What Are the Best Methods Availablefor the Primary Prevention of DentalCaries Initiation Throughout Life?In the last 30 years a number of community- and indivi-dual-level strategies for preventing caries, notably waterfluoridation and the use of fluoridated toothpastes, havebeen highly successful. This Consensus Conference didnot evaluate the evidence for effectiveness of water fluori-dation. This question has been the subject of public debate.It is widely accepted as both effective and of great impor-tance in the primary prevention of dental caries. In light ofthis remarkable accomplishment, this portion of the reportfocuses on interventions that may provide additional benefitin the primary prevention of dental caries in individual patients.

Some of the evidence on which this report is basedaddressed the effectiveness of interventions when used inpopulations not specifically selected on the basis of havinghigh risk for dental caries. Almost all of the relevant studiesinvolved populations of children between 6 and 15 years ofage. The interventions included application of acidulatedphosphate fluoride gel (APF), fluoride varnish, chlorhexedinegels, pit and fissure sealants, and the use of dentrifices andother products containing noncariogenic sweeteners.

Acidulated phosphate fluoride gel (APF): Evidence forthe efficacy of APF gel applied 1–2 times per year wasconsistently positive.

Fluoride varnish: The evidence for the benefit of applyingfluoride varnish to permanent teeth is generally positive. Incontrast, the evidence for effectiveness of fluoride varnishapplied to primary teeth is incomplete and inconsistent.

Chlorhexedine gels: The evidence for the use of chlor-hexedine gel is moderately strong, although many of thestudies demonstrating its effectiveness used concomitantpreventive measures.

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Pit and fissure sealants: Pit and fissure sealants have beendemonstrated to be effective in the primary prevention ofcaries, and their effectiveness remains strong as long asthe sealants are maintained.

Products containing noncariogenic sweeteners:Noncariogenic sweeteners have been delivered to teethas constituents of chewing gum, hard candy, and denti-frices. The evidence for both sorbitol and xylitol is positive,although the evidence for xylitol is stronger. Almost allstudies of these agents included other interventions,such as fluoridated dentifrices, dietary modification,and oral hygiene instruction.

Combination interventions: There is reason to believethat preventive strategies may be more effective whenthey are combined than when they are administeredindividually. Numerous combination interventions havebeen studied. These include combined fluoride interven-tions, chlorhexedine plus fluoride, chlorhexedine plussealants, and chlorhexedine plus xylitol. All studiesincluded instructions in dietary modification and oralhygiene and instructions for control and experimentalgroups. In general, these combination treatmentshave been shown to be effective in preventing cariesin children.

Consistent positive evidence was found for the effective-ness of all reviewed preventive interventions in unselectedpopulations of children. Furthermore, the effectivenessof these interventions appears to increase as baselineDMFS (decayed, missing, and filled surfaces) scoresincrease, suggesting that they may be particularlyeffective in high-risk populations while raising questionsabout their cost-effectiveness in low-risk populations.

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When review of the evidence is confined to studies aimedat high-risk individuals, there is a relatively small number ofmethodologically strong, sufficiently large studies specificallyaddressing the effectiveness of primary prevention interven-tions, with the exception of fluoride varnish, for which thereis fair evidence of effectiveness. For these reasons, the panelconcluded that carefully designed studies with adequatepower and sufficiently long follow-up may be necessary toselect the best intervention or combination of interventionsthat should be applied to selected groups.

The panel makes no comment on primary preventionof secondary caries, or on primary prevention of eitherocclusal or interproximal caries in adults, as no evidencewas available to address these questions. Evidenceregarding primary prevention of root caries is also verylimited. Additional studies will be required to define optimalpreventive intervention strategies for these conditions.

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What Are the Best Treatments Availablefor Reversing or Arresting the Progressionof Early Dental Caries?The caries process is endemic and potentially both prevent-able and curable. The latter can be achieved by identifyingand arresting or reversing the disease at an early stage.Although more research is needed, clinical strategies todo this already exist. These strategies include applicationof fluorides, chlorhexedine, sealants, antimicrobials, sali-vary enhancers, and patient education. Fluorides andchlorhexedine can be delivered as varnishes, rinses, orgels. Many of these same strategies are also appropriatefor primary prevention.

A number of the above treatment methods have beentested in clinical populations. However, the quantity andquality of the data vary by treatment.

1. Fluoride. The research data on fluorides in water anddentifrices support their efficacy. The data also supportthe use of fluoride varnishes. For rinses and gel applica-tions the evidence is promising but not definitive.

2. Chlorhexedine. For varnishes and gels, the data arepromising. Research data showing effectiveness ofchlorhexedine rinses are lacking.

3. Sealants. The use of pit and fissure sealants issupported by the data.

4. Combinations. Combinations of chlorhexedine,fluoride, and/or sealants are suggestive of efficacy.

5. Antimicrobials. Although mutans streptococci is recog-nized as part of the pathology of caries and therefore anantimicrobial approach would seem reasonable, currentdata are inadequate to support antimicrobial treatmentsother than chlorhexedine and fluorides, both of whichhave antibacterial properties.

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6. Salivary Enhancers. Although there are indications thatpathologically low salivary flow, as a consequence ofSjögren’s syndrome or as an effect of head/neck radiationtreatment or xerostomic medications, is associated withcaries, there is no evidence that low normal salivary flowproduces a similar outcome.

7. Behavioral Modification. Most interventions requirepatient adherence, and current data provide some supportfor the efficacy of office-based behavioral interventions.

While there has been considerable progress in dealingwith dental caries, it is still epidemic, particularly amongvulnerable groups. The detection and treatment of earlycarious lesions by nonsurgical measures has consider-able potential to further the reduction of this burden.Although more research on early dental caries is needed,data on primary prevention are sufficient to make somerecommendations for dental practice. Practice wouldbe further enhanced, however, by further research thataddressed caries in the adult population, secondarycaries, and root caries.

In the development of caries treatment, dentistry hasmoved historically from extraction to surgical restoration.Identification of early caries lesions and treatment withnon-surgical methods, including remineralization, repre-sent the next era in dental care.

This stopping and reversing of caries is dependent onearly and accurate diagnosis, which remains a developingfield. If maximum benefits are to be obtained, improveddiagnosis is essential.

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How Should Clinical Decisions RegardingPrevention and/or Treatment Be Affected byDetection Methods and Risk Assessment?At this time the panel senses a paradigm shift in the manage-ment of dental caries toward improved diagnosis of earlynoncavitated lesions and treatment for prevention and arrestof such lesions. Restorations repair the tooth structure, donot stop caries, and have a finite life span. They are them-selves susceptible to disease. With the defining of cariesas a multifactorial, multistage process extending from infec-tion to demineralization and cavitation, clear diagnostic andstaging criteria as well as a clear understanding of risk andprognosis are needed to determine dental treatment options.Evidence suggests that there are nonsurgical options forprevention and arrest and reversal of early noncavitatedlesions. The decision not to treat, or to prevent, arrest,reverse, and/or surgically treat, are choices based uponthese factors. Risk indicators also are considered in esti-mating future disease. Thus, diagnostic techniques andthe influence of risk indicators need to be evaluated forall teeth surfaces and patients of all ages.

Although the evidence shows that many diagnostic methodsare less than desirably accurate, current diagnostic interpreta-tions still must be used until new, more sensitive, techniquesare available and validated. The evidence-based reportssupported previous caries experience and pathologicallylow salivary flow rate as indicators of significant risk. Moststudies from the systematic reviews involved children andexcluded root caries, adults, and anterior teeth. Therefore,the clinician must extrapolate reportedly successful preven-tive and arresting/remineralization techniques from childrento adults, root caries, and anterior teeth. In the absence ofclear evidence on adequately sensitive diagnostic methodsfor detecting early noncavitated lesions and risk assessmentindicators, clinicians need guidelines for treatment.

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Because research is still evolving in these areas, a seriesof guidelines created by consensus groups using currentlyavailable information is needed for patient treatment. In theabsence of definitive evidence, choices must come fromhighly probable information. Selection of interventionsand evaluations of known risks need to be guided byquality studies and literature.

Other reviews of literature and higher quality clinicalstudies are needed to contribute to these guidelines.From guidelines, appropriate treatment(s) can bechosen. Examples of such guidelines already exist.

Longitudinal studies with outcomes assessments areneeded to determine the success of specific treatments.Long-term retention and functioning of treated teeth with-out recurrence of caries are essential outcome criteria.As evidence of better diagnostic methods, improvedtreatments, and clearer definition of risk indicators isestablished, treatment guidelines can be appropriatelyrefined and individualized for the patient.

The dental profession has been successful in promotingcaries prevention. Current information indicates that theopportunity now exists to extend prevention and treat-ment of caries to nonsurgical methods. These includefurther prevention, remineralization, and arrest of earlynoncavitated lesions. Controlled longitudinal studiesthat inform third-party payers can do much to supportthe adoption of more advanced diagnostic, preventive,and nonsurgical techniques into the practice of dentistry.Studies that explore a range of reimbursement optionsmay be helpful in identifying reimbursement methodsthat both encourage and reward preventive nonsurgicaldental treatment. Practicing dentists must have adequateincentives to apply these findings. Educational institutionsand their curricula, state and national dental boards andboard examiners, and accreditation agencies must alsosupport the growing evidence for prevention and non-surgical treatment where indicated.

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What Are Promising New ResearchDirections for the Prevention, Diagnosis,and Treatment of Dental Caries?In prefacing the listing of promising new research areas,it should be noted that the panel identified significantconcerns about the nature of previous clinical researchon dental caries. The science of clinical research designhas advanced rapidly in the past several decades. How-ever, the panel deemed that the design and executionof caries trials and epidemiological studies have notkept pace with the current standard. Many previousclinical caries studies were neither well designed norwell analyzed. They tended to be small, underpowered,improperly controlled, and incompletely described.Thus, when subjected to modern systematic reviewtechniques, the overall quality of the database wasjudged usually to be in the range of poor to fair. Accord-ingly, NIDCR should expand significantly its clinical andresearch program to match the recent expansion inclinical training to promote improvement in the quality,size, and reporting of clinical dental caries studies andthe number of well-trained clinical investigators. In thefuture, it will be imperative that markedly improvedtechniques be applied in each clinical study. In theinterim, it would behoove clinical caries researchersto consult widely with clinical research methodologistsand to ensure that their studies adhere to nationaland international criteria for reporting of studiesas used in systematic reviews. In this manner, thesuccessful exploration of the clinical opportunitieslisted below will be facilitated.

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Major Clinical Caries Research Directions1. The Epidemiology of Primary and Secondary Caries

needs to be systematically studied with populationcohort studies that collect information on natural history,treatment, and outcomes across the age spectrum.

2. Research into Diagnostic Methods, including establishedand new devices and techniques, is needed. Develop-ment of standardized methods of calibrating examinersis needed.

3. Clinical Trials of established and new treatment methodsare needed. These should conform to contemporarystandards of design, implementation, analysis, andreporting. They should include trials of efficacy.

4. Systematic research on caries Risk Assessment isneeded using population-based cohort techniques.

5. Studies of Clinical Practice, including effectiveness,quality of care, outcomes, health-related quality of life,and appropriateness of care are needed.

6. Genetic Studies are necessary to identify genesand genetic markers of diagnostic, prognostic,and therapeutic value.

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ConclusionsThis Consensus Development Conference, the first spon-sored by the NIH on dental caries, provided an excellentvenue to describe the great success that has been achievedin reducing caries prevalence. More importantly, it provideda public forum to review both the strengths and weaknessesof current dental caries research and clinical procedures.Effective preventive practices, such as the use of fluoride,sugarless products, and dental sealants were reconfirmed,and clinical studies to identify more conservative but moreeffective nonsurgical and surgical approaches are to beapplauded. However, it was evident that current diagnosticpractices are inadequate to achieve the next level of cariesmanagement, in which noncavitated lesions are identifiedearly so that they can be managed by nonsurgical methods.Some new and sensitive diagnostic approaches were pre-sented to the panel, but concern was raised about the useof histological confirmation of caries presence as an appro-priate gold standard. The resolution of these issues requiresthat surrogate markers, validated by histological confirma-tion, be developed. Once these surrogate markers of dentalcaries activity are validated, rapid advances in our under-standing of the caries process are certain to follow.

In spite of optimism about the future, the panel was disap-pointed in the overall quality of the clinical data set that itreviewed. Far too many studies used weak research designsor were small or poorly described, and consequently hadquestionable validity. There was a clear impression thatclinical caries research is underfunded, if not undervalued.Moreover, incomplete information on the natural history ofdental caries, the inability to accurately identify early lesionsand/or lesions that are actively progressing, and the absenceof objective diagnostic methods are troubling. Several sys-tematic reviews of the literature presented at the ConsensusDevelopment Conference concluded that the majority of thestudies were inadequate, and it is clear that a major invest-ment of research and training funds is required to seize thecurrent opportunities.

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This is not to say that the diagnostic, preventive, and treat-ment techniques currently used do not work, but rather thatearlier studies to support their efficacy do not meet currentscientific standards. Indeed, given the dramatic improve-ments in reducing dental caries prevalence in the past 30years, both consumers and health professionals shouldnot depart from the practices which are likely to have con-tributed to this oral health improvement, including the useof a variety of fluoride products, dietary modification, pitand fissure sealant, improved oral hygiene, and regularprofessional care. In addition, pending new data, cliniciansshould apply both preventive and therapeutic interventionsin the manner in which they have been studied. When solidconfirmation of the effectiveness of promising new diag-nostic techniques, nonsurgical treatments of noncavitatedlesions, and conservative surgical interventions for cavitatedlesions are obtained, dental health professionals and thepublic should embrace them rapidly in anticipation ofattaining still higher levels of oral health. None of theseanticipated advances will be achieved, however, in theabsence of a progressive, third-party payment systemthat acknowledges its responsibility to compensate pro-viders adequately to ensure that the next generation ofconservative therapy can be enjoyed by the American people.

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ConsensusDevelopment Panel

Michael C. Alfano, D.M.D., Ph.D.Panel and Conference

ChairpersonDeanNew York UniversityCollege of DentistryNew York, New York

Ian D. Coulter, Ph.D.ProfessorUniversity of California,

Los AngelesSchool of DentistryLos Angeles, California

and RANDSanta Monica, California

Meghan B. Gerety, M.D.Professor of Medicine/GeriatricsUniversity of Texas Health

Science Centerat San Antonio

San Antonio, Texas

Thomas C. Hart, D.D.S., Ph.D.Associate ProfessorDirector, Center for Craniofacial

and Dental GeneticsDepartment of Oral Medicine/

Pathology/GeneticsSchool of Dental MedicineGraduate School

of Public HealthUniversity of PittsburghPittsburgh, Pennsylvania

Peter B. Imrey, Ph.D.ProfessorDepartments of Statistics and

Medical Information ScienceUniversity of Illinois

at Urbana-ChampaignChampaign, Illinoisand Center for Molecular

Biology of Oral DiseasesUniversity of Illinois at ChicagoCollege of DentistryChicago, Illinois

Linda LeResche, Sc.D.Research ProfessorDepartment of Oral MedicineUniversity of WashingtonSeattle, Washington

Joseph Levy, M.D.Professor of Clinical Pediatrics

in SurgeryDirectorChildren’s Digestive

Health CenterChildren’s Hospital of New YorkColumbia UniversityNew York, New York

Russell V. Luepker, M.D., M.S.Professor and HeadDivision of EpidemiologySchool of Public HealthUniversity of MinnesotaMinneapolis, Minnesota

Alan G. Lurie, D.D.S., Ph.D.Head, Division of Oral and

Maxillofacial RadiologyUniversity of Connecticut School

of Dental MedicineFarmington, Connecticut

Roy C. Page, D.D.S., Ph.D.DirectorRegional Clinical Dental

Research CenterProfessor, Pathology

and PeriodonticsUniversity of WashingtonSeattle, Washington

Leslie A. Rye, D.D.S., M.S.T.General PractitionerReston, Virginia

Lucille SmithExecutive DirectorVoices of Detroit InitiativeDetroit, Michigan

Clay B. Walker, Ph.D.ProfessorDepartment of Oral BiologyUniversity of FloridaGainesville, Florida

26

Speakers

Kenneth J. Anusavice, Ph.D.,D.M.D.

Associate Dean for ResearchProfessor and ChairDepartment of

Dental BiomaterialsUniversity of FloridaCollege of DentistryGainesville, Florida

Jane C. Atkinson, D.D.S.Assistant DeanClinical Affairs ProfessorDepartment of Oral MedicineUniversity of Maryland

Dental SchoolBaltimore, Maryland

James Bader, D.D.S., M.P.H.Research ProfessorSheps Center for

Health ServicesResearch and School

of DentistryUniversity of North Carolina

at Chapel HillChapel Hill, North Carolina

David W. Banting, D.D.S.,Ph.D., DDPH, M.Sc., FRCD(C)

ProfessorFaculty of Medicine

and DentistrySchool of Dentistry, Division

of Community DentistryUniversity of Western OntarioLondon, Ontario, Canada

William H. Bowen, B.D.S., Ph.D.Welcher Professor of DentistryCenter for Oral BiologyUniversity of Rochester School

of Medicine and DentistryRochester, New York

Brian A. Burt, B.D.S.,Ph.D., M.P.H.

ProfessorDepartment of EpidemiologySchool of Public HealthUniversity of MichiganAnn Arbor, Michigan

Page W. Caufield, D.D.S., Ph.D.DirectorSpecialized Caries

Research CenterSchool of DentistryUniversity of Alabama

at BirminghamBirmingham, Alabama

Brian H. Clarkson, Ph.D.,M.S., L.D.S.

Department ChairDepartment of Cariology,

Restorative Sciences,and Endodontics

University of MichiganSchool of DentistryAnn Arbor, Michigan

S. Brent Dove, D.D.S., M.S.Division HeadOral Diagnosis/Oral

Medicine DivisionDepartment of Dental

Diagnostic ScienceUniversity of Texas Health

Science Center at SanAntonio Dental School

San Antonio, Texas

Catherine Hayes, D.M.D.,D.M.Sc.

Assistant ProfessorDepartment of Oral Health

Policy and EpidemiologyHarvard School of

Dental MedicineBoston, Massachusetts

27

Alice M. Horowitz, Ph.D.Senior ScientistNational Institute of Dental

and Craniofacial ResearchNational Institutes of HealthBethesda, Maryland

Amid I. Ismail, B.D.S.,M.P.H., Dr.P.H.

ProfessorDepartment of Cariology,



Edwina Kidd, B.D.S., Ph.D.,F.D.S., R.C.S.

Professor of CariologyDepartment of

Conservative DentistryGKT Dental InstituteGuy’s HospitalLondon Bridge, United Kingdom

James L. Leake, D.D.S.,M.Sc., DDPH, FRCD(C)

Professor and Discipline HeadCommunity DentistryUniversity of TorontoToronto, Ontario, Canada

Cataldo W. Leone, D.M.D., D.Sc.Associate ProfessorDepartment of Periodontology

and Oral BiologyBoston University School

of Dental MedicineBoston, Massachusetts 02118

Dorothy D. McComb, B.D.S.,M.Sc.D., FRCD(C)

Professor and HeadDepartment of

Restorative DentistryUniversity of TorontoToronto, Ontario, Canada

Peter Milgrom, D.D.S.Professor and DirectorDental Fears Research ClinicDental Public Health Sciences

and Health ServicesUniversity of WashingtonSeattle, Washington

Ernest Newbrun, D.M.D., Ph.D.Professor EmeritusDepartment of StomatologyUniversity of California,

San FranciscoSan Francisco, California

Denis O’Mullane, B.D.S., Ph.D.,F.D.S., F.F.D.

ProfessorOral Health Services

Research CentreUniversity Dental School

and HospitalWilton, Cork, Ireland

Nigel B. Pitts, B.D.S., Ph.D.,R.C.S., MFPHM

DirectorDental Health Services

Research UnitDental Hospital and SchoolUniversity of DundeeDundee, Scotland

Susan T. Reisine, Ph.D.ChairmanDepartment of Behavioral

Sciences andCommunity Health

University of ConnecticutHealth Center

Farmington, Connecticut

Stephen F. Rosenstiel, B.D.S.,M.S.D.

ChairDepartment of Restorative

Dentistry, Prosthodontics,and Endodontics

Ohio State UniversityCollege of DentistryColumbus, Ohio

28

R. Gary Rozier, D.D.S., M.P.H.ProfessorDepartment of Health

Policy and AdministrationSchool of Public HealthUniversity of North Carolina

at Chapel HillChapel Hill, North Carolina

Charles F. Shuler, D.M.D., Ph.D.DirectorGeorge and Mary Lou Boone

Professor of CraniofacialMolecular Biology

Center for CraniofacialMolecular Biology

University of Southern CaliforniaLos Angeles, California

George K. Stookey, Ph.D.Associate Dean for ResearchIndiana University School

of DentistryIndianapolis, Indiana

Jason M. Tanzer, D.M.D., Ph.D.ProfessorDepartment of Oral DiagnosisUniversity of Connecticut

Health CenterFarmington, Connecticut

Norman Tinanoff, D.D.S., M.S.Professor and ChairDepartment of Pediatric

DentistryUniversity of MarylandDental SchoolBaltimore, Maryland

Elizabeth T. Treasure, B.D.S.,Ph.D., FRACDS, FDSRCS

ProfessorDepartment of Dental Health

and DevelopmentDental SchoolUniversity of Wales College

of MedicineCardiff, Wales

Jane A. Weintraub,D.D.S., M.P.H.

Lee Hysan ProfessorChairDivision of Oral Epidemiology

and Dental Public HealthDepartment of Preventive and

Restorative Dental SciencesUniversity of California,

San FranciscoSchool of DentistrySan Francisco, California

B. Alexander White, D.D.S.,Dr.P.H., M.S.

Senior InvestigatorKaiser Permanente Center

for Health ResearchPortland, Oregon

Domenick T. Zero, D.D.S., M.S.Professor and ChairDepartment of Preventive and

Community DentistryDirectorOral Health Research InstituteIndiana University School

of DentistryIndianapolis, Indiana

29

Planning Committee

Alice M. Horowitz, Ph.D.Planning Committee

ChairpersonSenior ScientistNational Institute of Dental


Michael C. Alfano, D.M.D., Ph.D.Conference and

Panel ChairpersonDeanNew York University College

of DentistryNew York, New York

James Bader, D.D.S., M.P.H.Research ProfessorSheps Center for Health

Services Research andSchool of Dentistry

University of North Carolinaat Chapel Hill

Chapel Hill, North Carolina

Jerry M. ElliottProgram Analysis and

Management OfficerOffice of Medical Applications

of ResearchOffice of the DirectorNational Institutes of HealthBethesda, Maryland

Isabel Garcia, D.D.S., M.P.H.Special Assistant for

Science TransferOffice of Communications

and Health EducationNational Institute of Dental


Amid I. Ismail, B.D.S.,M.P.H., Dr.P.H.

ProfessorDepartment of Cariology,



Ralph V. Katz, D.M.D.,M.P.H., Ph.D.

ChairDepartment of Epidemiology

and Health PromotionNew York UniversityCollege of DentistryNew York, New York

John V. Kelsey, D.D.S., M.B.A.Dental Team LeaderCenter for Drug Evaluation

and ResearchU.S. Food and Drug

AdministrationRockville, Maryland

David L. Klein, Ph.D.Bacterial Respiratory Diseases

Program OfficeNational Institute of Allergy

and Infectious DiseasesNational Institutes of HealthBethesda, Maryland

Dushanka V. Kleinman,D.D.S., M.Sc.D.

Deputy DirectorNational Institute of Dental


Dennis F. Mangan, Ph.D.Chief of Infectious Diseases

and Immunity BranchDivision of Extramural ResearchNational Institute of Dental


30

J. Ricardo Martinez, M.D.,M.P.H.

DirectorDivision of Extramural ResearchNational Institute of Dental


Susan Runner, D.D.S., M.A.Branch Chief, Dental DevicesCenter for Devices and

Radiological HealthU.S. Food and Drug

AdministrationRockville, Maryland

Charles F. Shuler, D.M.D., Ph.D.DirectorGeorge and Mary Lou Boone

Professor of CraniofacialMolecular Biology

Center for CraniofacialMolecular Biology

University of Southern CaliforniaLos Angeles, California

Stanley Slater, M.D.Deputy Associate DirectorGeriatric ProgramNational Institute on AgingNational Institutes of HealthBethesda, Maryland

George K. Stookey, Ph.D.Associate Dean for ResearchIndiana UniversitySchool of DentistryIndianapolis, Indiana

ConferenceSponsors

National Institute of Dentaland Craniofacial Research

Lawrence A. Tabak, D.D.S., Ph.D.Director

Office of Medical Applicationsof Research

Barnett S. Kramer, M.D., M.P.H.Director

ConferenceCosponsors

National Institute on AgingRichard J. Hodes, M.D.Director

U.S. Food and DrugAdministration

Bernard A. Schwetz, D.V.M., Ph.D.Acting Principal Deputy

Commissioner

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