The Journal of the American Dental Association
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J Am Dent Assoc, Vol 133, No 9, 1274-1275.
© 2002 American Dental Association

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DENTAL PRODUCT SPOTLIGHT

Pit and fissure sealants


   PRODUCT NAMES AND MANUFACTURERS
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
3M ESPE Concise Light Cure White and Concise White—3M ESPE Dental Products, 3M Center Building 260-2B-09, St Paul, Minn. 55144-1000, 1-800-634-2249, "www.3M.com"; Baritone L3—Confi-Dental Products Co., 416 S. Taylor Ave., Louisville, Colo. 80027-3017, 1-303-665-7535; Alpha-Dent Chemical Cure, Alpha-Dent Light Cure—Dental Technologies Inc., 6901 Hamlin Ave., Lincolnwood, Ill. 60712, 1-800-835-0885; Prisma-Shield Compules Tips VLC Tinted, Prisma-Shield VLC Filled—Dentsply L.D. Caulk Division, 38 W. Clarke Ave., P.O. Box 359, Milford, Del. 19963-0359, 1-800-532-2855; Helioseal and Helioseal F—Ivoclar-Vivadent Inc., 175 Pineview Drive, Amherst, N.Y. 14228, 1-800-533-6825, "www.ivoclarvivadent.us.com"; Seal-Rite and Seal-Rite Low Viscosity—Pulpdent Corp., 80 Oakland St., P.O. Box 780, Watertown, Mass. 02471-0780, 1-800-343-4342, "www.pulpdent.com".

Pit and fissure sealants have been used successfully for many years to prevent caries. The sealants are resin-based materials that harden by free radical polymerization. Sealants are cured either chemically or by light. Sealants also may contain fluoride that is released over time.


   CONSIDERATIONS FOR ACCEPTANCE
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
The clinical effectiveness of sealants is well established. Swift1 and Weintraub2 reviewed the pertinent literature; in their review, they included data on the success of sealant use in different populations (children vs. adults, in fluoridated vs. nonfluoridated communities) and on microbial activity beneath sealants. Because extensive information on the effectiveness of sealants has been published, the ADA Acceptance Program does not require clinical studies, but does require data from laboratory testing to ensure that products meet certain physical property requirements. These physical property requirements are identified in American National Standard/American Dental Association Specification No. 39 for Pit and Fissure Sealants.3 Specification No. 39 classifies sealants according to their curing method: chemical (type I) and external-energy-cured (type II).


   SAFETY AND EFFICACY DATA
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
Specification No. 39 established the following requirements:

– that the working time for type I sealants is not less than 45 seconds;
– that the setting time is within 30 seconds of the manufacturer’s instructions and does not exceed three minutes;
– that the curing time for type II sealants is not more than 60 seconds;
– that the depth of cure for type II sealants is not less than 0.75 millimeters;
– that the uncured film thickness is not more than 0.1 mm;
– that sealants meet the biocompatibility requirements of American National Standard/American Dental Association Document No. 41 for Recommended Standard Practices for Biological Evaluation of Dental Materials.4


   INSTRUCTIONS FOR USE
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
Perform a prophylaxis on the area to be sealed using a prophylaxis paste that does not contain fluoride or oil. Rinse the area thoroughly with water. Once clean, isolate the area with cotton rolls or a rubber dam (inadequate isolation and subsequent contamination is the most common reason for sealant failure). Dry teeth with moisture-free and oil-free compressed air. Apply etchant to the area for approximately 60 seconds. Rinse well and dry with moisture-free and oil-free air. The etched areas should appear dull and frosty-white; if not, re-etch them. Teeth with high fluoride content and some primary teeth may require longer etching times. Etching solutions may not penetrate deep recesses, which also may retain some debris. Therefore, it is suggested that these areas be cleaned and prepared with a bur or air abrasion to allow penetration of the sealant. Do not allow the etched surfaces to be contaminated with moisture, as this may cause the sealant to fail. Apply sealant to the occlusal surface, taking care not to create air bubbles. Cure the sealant with light, or allow it to self-cure, according to the manufacturer’s directions. Once the sealant has set, wipe the surface with cotton to remove the unpolymerized resin. Examine the condition of the sealant at six months and re-apply sealant to any exposed areas.


   INDICATIONS AND PRECAUTIONS
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
Sealants may be indicated for children and adults who

– for a variety of reasons, may be at moderate or high risk of developing dental caries;
– have incipient caries (limited to enamel of pits and fissures);
– have existing pits and fissures that are anatomically susceptible to caries;
– have sufficiently erupted permanent teeth with susceptible pits and fissures.5

The etching solution contains phosphoric acid; therefore, contact with skin, oral mucosa, eyes and dentin should be avoided. In case of contact, the affected area should be flushed with water immediately.


   REFERENCES
 TOP
 PRODUCT NAMES AND MANUFACTURERS
 CONSIDERATIONS FOR ACCEPTANCE
 SAFETY AND EFFICACY DATA
 INSTRUCTIONS FOR USE
 INDICATIONS AND PRECAUTIONS
 REFERENCES
 
  1. Swift EJ. The effect of sealants on dental caries: a review. JADA 1988;116:700–4.[Abstract]

  2. Weintraub JA. The effectiveness of pit and fissure sealants. J Public Health Dent 1989;49:317–30.[Medline]

  3. American National Standards Institute and American Dental Association. American National Standard/American Dental Association specification no. 39 for pit and fissure sealants. Chicago: American Dental Association, Council on Scientific Affairs; 1992 (reaffirmed 1999). Available at: "www.ada.org/prof/prac/stands/Specification%20No.%20391.pdf". Accessed July 26, 2002.

  4. American National Standards Institute and American Dental Association. American National Standard/American Dental Association document no. 41 for recommended standard practices for biological evaluation of dental materials and 41a, addendum. Chicago: American Dental Association, Council on Scientific Affairs; 2001.

  5. ADA Council on Access, Prevention and Interprofessional Relations; ADA Council on Scientific Affairs. Dental sealants. JADA 1997;128:485–8.[Abstract/Free Full Text]





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