perma soft 1716

DIRECTIONS FOR USE

Laboratory Technique

Chairside Technique

1Indications for Use:

PermaSoft Soft Denture Liner is a twocomponent system comprised byblending a powder component ofpolyethylmethacrylate and a liquidcomponent of Di-n-butyl phthalate,ethyl acetate and ethyl alcohol. It isindicated for use in stabilizing andrelining complete and partial dentures,cushioning sensitive tissues andretaining overdentures. Permasoft canbe processed using direct or indirecttechniques. The compliance andresiliency of Permasoft can be variedby altering the powder/liquid ratio.

Contraindications:

None known.

Warnings:

PermaSoft Soft Denture Liner containsmethacrylate resins which may causeskin sensitization (allergic contactdermatitis) or other allergic reactionsin susceptible persons. If skinsensitization occurs, discontinue use. Ifdermatitis or other symptoms persist,seek medical attention. PermaSoftliquid contains ethyl alcohol andshould be kept away from sources ofignition. Avoid contact with eyes. Incase of accidental contact, washthoroughly with water and seekmedical attention.

Keep containers tightly closed whennot in use.

Precautions:

Work in a well ventilated area whenapplying PermaSoft Sealer and DONOT place prosthesis in patientsmouth until PermaSoft Sealer iscompletely dry and prosthesis hasbeen rinsed with water.

Its longevity of service is reducedwhen used as a long-term soft lineragainst sharp, knife edge ridges. Itcan be used for application over knifelike ridges, but use a powder/liquidratio of 3:1 for more resistance tohairline cracking. Adhesion ofPermaSoft to each and every denturebase resin formulation has not beentested. Carefully evaluate adhesion of PermaSoft to denture baseformulations which do not containpolymethylmethacrylate.

Store at room temperature.

Adverse Reactions:

Allergic contact dermatitis and other allergic reactions may occur in susceptible individuals.

Preparation:

1. Upon receipt of reline impression,pour a stone model. Flask or jigthe model with the impression inplace following standard relineprocedures.

2. After the flask has set for onehour, place it in a boilout tankfor approximately 15 minutes.Remove it and separate the upperand lower portions of the flask.

3. Gently scrub the lower half ofthe flask (model half) with amild detergent and rinsethoroughly with clean, hot

water. Post dam, if necessary;apply separator; allow theseparator to dry.

4. Prepare the denture base for thesoft liner by relieving the acrylictissue-bearing surface by 2mmor more. Liner can extend abovethe peripheral roll to any length.

5. Eliminate severe undercuts androughen areas of denture baseto be relined.

6. Gently scrub the upper half of theflask (denture half) and rinse withhot water. Apply separator tostone or plaster; let dry.

STEP BY STEP INSTRUCTIONSThe compliance and resiliency of PermaSoft Soft Denture Liner can be varied byaltering the powder/liquid ratio. PermaSoft mixed using a powder/liquid(vol/vol) ratio of 2:1 results in a very compliant lining layer suitable for post-surgical prosthetics or as a cushion against sensitive tissues. PermaSoft mixedusing a powder/liquid ratio of 2 1/2 :1 results in a firmer lining which effectivelystabilizes partial and complete dentures while still providing the advantages of asoft-liner for long-term use. PermaSoft mixed using a powder-liquid ratio of 3:1results in a lining capable of retaining overdentures onto natural teeth, ballabutments or bar connectors. PermaSoft forms a durable bond with conventionalmethacrylate resin denture base formulations.

2

LABORATORY TECHNIQUE

Density

Softest

StandardLining

Firm

Ratio (P:L)

2:1

21/2 :1

3:1

Powder

8cc

10cc

12cc

Liquid

4cc

4cc

4cc

Applications

Post-surgical prostheticsCushion for sensitive tissue

Complete denture relinesPartial denture stabilizationOverdenture retained on healing caps

Overdenture retained by ball abutments,bar connectors or teeth.

3Measuring & Mixing:

7. To measure: use the graduatedglass vials marked Powderand Liquid. You can controlthe liners softness by modifyingthe powder/liquid ratio asshown in the chart above.

Note: At a 2:1 ratio, lineris the softest. A lightpowdering of liners surface will absorb anyexcess liquid.

8. Pour powder (all at once) intothe liquid in mixing cup; Stirvery slowly (to avoid theintroduction of bubbles) until allof the powder particles aretotally moistened. The mixtureconsistency instantly turnssticky and honey-like.

Application:

9. Immediately, spread the mixtureonto the totally dry denturebase surface.

10. Close the flask or jig for curing. Injig, use fingertip coated with themixing liquid to taper and smoothany excess material 3mm ontolabial and buccal surfaces.

Curing:

11. Place flask onto a press; slowlyapply pressure until the flask iscompletely closed.

Note: Do not trial packthe soft liner.

12a. In a flask: Place flask in a curing

unit filled with boiling water(212F/100C) for 15 minutes.

12b. In a jig: Place jig in a curingunit or in a pressure pot at(20psi/1.4bar) in steaming hotwater (between 122F/50C to165F/74C) for 10 minutes.

Finishing:

13. Remove cured denture fromflask or jig; chill it a few minutes in an ice water bath to temporarily harden the softliner for easy trimming.

14. Remove excess flash with sharpscissors, scalpel or suitablerotary instrument (i.e. acrylic bur,rubber point or finishing stone).Feather taper liner 3mm ontolabial and buccal surfaces.

15. If desired, finish with a wet ragwheel and pumice to furthersmooth the surface. Do nothigh-shine the liner using a buffwheel as PermaSoft Sealerprovides a high-gloss finish.

Sealing:

16. Dry the liner surface using airor warm air blower to removeall surface moisture. Apply agenerous coat of PermaSoftSealer over the totally dry softliner and air dry for 2+ min-utes. Repeat procedure addinga second coating. A third coat of PermaSoft Sealer canbe applied on non-retentive fitting surfaces.

4Additional Information:

Note: Provide Patient CareCard to instruct care &cleaning of the soft liner.

Note: To adjust, refit orrepair: roughen the sur-face, apply a fresh mixof soft liner, follow directions above forApplication, Curing,Finishing and Sealing.

Note: The Powder is avail-able in a clear shadewhich can be used to re-tain transparent acrylicmouth guards, bite platesand splints, to protect ve-neers, and as a gasketconnector around teeth.

Lining a New Denture:

Preparation:

1. Invest denture, wax-up and boil-out in the usual manner. Applyseparator to denture half ofmould. Allow the separator to dry.

2. Form a spacer on the modelfrom 1mm to 2+mm inthickness. Allow spacer tooverlap the peripheral roll 3mmonto the labial and buccalsurfaces. Soft liner can extendabove the peripheral roll to any length.

3. With spacer in place, trial packthe acrylic with dry sheets. After final packing of acrylic,allow 20 minutes to snap setthe acrylic while flask is in the press.

4. Open flask, remove spacer andclean model. Apply separatoronto the model-side stonesurfaces. Allow the separator to dry.

Measuring & MixingApplication:

(Follow instructions on page 2.)

Curing:

Cure per manufacturers instruction forthe new acrylic resin being used.

Finishing and Sealing:

(Follow instructions on page 3.)

5Preparation:

1. Relieve all undercuts andremove 2mm or more of acrylicon the tissue side of the dentureto make room for the soft liner.

2. Roughen the peripheral roll plus3mm of the buccal and labialsurfaces.

3. Clean and dry the areas wherethe soft liner is to be applied.Use petroleum jelly or a watersoluble substitute to coat theinterproximal surfaces that arenot meant to be lined. This willease finishing.

Measuring & Mixing:4. To measure: Use the graduated

glass vials marked Powderand Liquid. You can controlliners softness by modifying thepowder/liquid ratio as shown inthe chart above.

Note: At a 2:1 ratio, lineris the softest. A lightpowdering of liners

surface will absorb anyexcess liquid.

5. Pour powder (all at once) intothe liquid in mixing cup; Stirvery slowly (to avoid theintroduction of bubbles) until allof the powder particles aretotally moistened. The mixtureconsistency instantly turnssticky and honey-like.

Application:

6. Immediately, spatulate andspread the mixture onto thetotally dry denture.

7. Apply lubricant to patients lipsor ask patient to moisten lips asthe soft liner does not adhere towet areas.

Note: For patients with sorespots or tissue/taste sensitivity,rinse the mouth for 20 secondswith an anesthetic mouth rinse.

8. Place denture in the mouth andinstruct the patient to closegently into occlusion for one

CHAIRSIDE TECHNIQUE

Density

Softest

StandardLining

Firm

Ratio (P:L)

2:1

21/2 :1

3:1

Powder

8cc

10cc

12cc

Liquid

4cc

4cc

4cc

Applications

Post-surgical prostheticsCushion for sensitive tissue

Complete denture relinesPartial denture stabilizationOverdenture retained on healing caps

Overdenture retained by ball abutments,bar connectors or teeth.

6minute while performing musclemoulding at the same time, ifdesired.

9. Remove denture from the mouth.The soft liner should completelyoverlap the peripheral roll.

10. Use a fingertip coated with themixing liquid to taper andsmooth the excess material 3mmonto the labial and buccalsurfaces; then cure immediately.

Curing:

11. Place the denture, reline sideup, into a cup filled withsteaming Hot Water (between122F/50C to 165F/74C)and cure for 10 min. Ifavailable, place in a pressurepot; cure in Hot Water (between122F/50C to 165F/74C) at(20psi/1.4 bar) for 10 min.

12. After curing, chill the denture inCold Water or Ice Water orspray the liners surface with askin refrigerant to temporarilyharden the soft liner for easytrimming.

Finishing & Sealing:

13. Remove excess flash with sharpscissors or scalpel. Feather taperthe material onto the labial andbuccal surfaces with an acrylicbur and smooth with a largerubber point or finishing stone.

14. If desired, finish with a wet ragwheel and pumice to furthersmooth the liner surface. Do nothigh-shine the soft liner.

15. Dry the liner surface using airor warm air blower to removeall surface moisture. Apply agenerous coat of PermaSoftSealer over the totally dry softliner and air dry for 2+ min.Repeat procedure adding asecond coating. A third coat ofPermaSoft Sealer can be appliedon non-retentive fitting surfaces.

DO NOT place denture inpatients mouth until PermaSoftSealer is completely dry and rinsed.

Patient Delivery:

Give patient a Patient Care Card toinstruct him/her on care and cleaningof the soft liner.

1) Soak only 10 min. in denturecleaner.

2) Warn patient not to scrub thesoft liner with a hard-bristlebrush; and

3) Request annual re-sealing of soft liner and dentalexamination to assure proper fit.

Note: To adjust, refit orrepair; roughen thesurface, apply a freshmix of soft liner, insert,cure, finish and re-seal.

Note: Liner will cure in 5minutes in-the-mouth forthin, small area relines.

Note: The Powder isavailable in a Clearshade which can be used

7to retain transparentacrylic mouth guards, biteplates and splints, as agasket connector aroundteeth, and to fill voids toeliminate food traps.

Implant OverdentureTechnique:

This patented implant overdenturetechnique was developed to aid in theprogressive healing process followingthe surgical placement of implants. Itis well suited for this chairsideapplication due to ones ability to varythe liners degree of softness, (seemixing ratios and applications inchart on page 4.)

Post-Surgical Placement:

After a one to two week intervalfollowing the implant placement, linethe tissue side of the overdenture for asoft, light load.

Note: Initially, use softest linermix ratio of 2 parts powder to1 part liquid.

After suture removal, block out sutureline (indentation) with dry foil orsuitable material and reline followingthe Chairside Technique. Make suresoft material does not interfere withhealing site or tissue flap. This softliner cushions tender areas and itssealer provides a non-absorbent,hygienic surface.

Healing Cap Exposure:

After an appropriate implantintegration phase, perform the

second stage reline. This requires anew application of soft liner to therelieved tissue side to anchor overhealing caps.

Note: Use the standard linermix ratio of 21/2 parts powderto 1 part liquid.

This Healing Cap overdenture enablesa gradual healing load with lightfunctional stimulus to the implant. Thisthin area reline will cure in-the-mouthin 5+ minutes.

Long Term Retention:

After attachment of ball abutments orbar connectors, reline overdenture toform gasket over balls or barswithout O-rings or clips.

Note: Use the firmest liner mixratio of 3 parts powder to 1part liquid.

The liner absorbs torque pressure andprovides retention for long term servicewith easy chairside adjustment.

8Introduction

Long-lasting and easy to use,PermaSoft Clear Powder possesses thesame working characteristics asPermaSoft Pink Powder. Once cured,the transparency of PermaSoft ClearPowder makes it ideal for use withany clear acrylic resin appliance (e.g.night guards, bite plates) or as agasket connector around teeth in aremovable denture.

Soft Lining of Clear Acrylic Appliance

1. Process acrylic appliance inusual manner.

2. Relieve 2mm of acrylic from theocclusal surface of the applianceto make room for the soft lining.

Note: Maintain an acrylic border no thinner than1mm to support soft lining.

3. Clean and thoroughly dry areaswhere soft liner is to be applied.

4. To place soft lining, refer todirections for LaboratoryTechnique or ChairsideTechnique.

Creating a Gasket inRemovable Denture

1. Create a hole in denture with2mm to 3mm of space aroundexisting tooth or teeth to allowroom for PermaSoft gasket.

2. Roughen 3mm areasurrounding the newly-createdhole(s) on all surfaces where thesoft liner will adhere.

3. To measure: Use the graduatedglass vials marked Powder andLiquid. For this application werecommend a 3:1 Powder-to-Liquid ratio.

4. Apply lubricant to all areaswhere you do not want the softliner to adhere.

5. Follow Mixing & Measuringinstructions in Directions for Use.

6. Spatulate mixture onto the tissueside of the totally dry denturebeneath created hole(s).

7. Seat the denture over theexisting tooth or teeth. The soft liner will flow out throughthe hole.

TECHNIQUE FOR CLEAR POWDER

Density

StandardLining

Firm

Ratio (P:L)

21/2 :1

3:1

Powder

10cc

12cc

Liquid

4cc

4cc

Applications

Retain and cushion of clear acrylicappliances, such as night guards, bite plates,splints, TMJ & sleep apnea devices

Gasket in a removable denturefor retention on existing teeth

Fills voids beneath clasps and under retainers to eliminate food traps on acrylic prosthesis

98. Use a fingertip coated withthe mixing liquid to taper andsmooth excess soft liner 3mmonto the labial and buccal surfaces.

9. Follow Curing, Finishing &Sealing instructions in Directionsfor Use.

Soft Lining of New Appliance

Follow Directions for Use, LaboratoryTechnique, Lining New Denture, inorder to place PermaSoft Clear insidetransparent acrylic appliances such asa night guard or bite plate. Make sureto leave 1+mm of acrylic border tosupport the soft material inside the arch.

2004, 2006 DENTSPLY International Inc. All rights reserved. Printed in U.S.A. NPK1716 Rev. H(01/11)

Manufacturer: DENTSPLY International Inc.570 West College Avenue, York, PA 17405-08721-800-243-1942www.austenal.dentsply.com or www.dentsply.com

U.S. Patent No. 5,513,988; 5,678,993; 5,885,077