Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

Cairo University (CU)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Caries, Dental

Treatments: Combination Product: BioCoat® by Premier®.; Combination Product: 3M™ Clinpro™ Sealant.

Study type: Interventional

Funder types: Other

Identifiers

NCT03779893

14011989

Details and patient eligibility

About

This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination & VistaCAM.

Full description

In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.

With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Enrollment: 38 estimated patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria of participants:

• Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
• 19 - 40 years.
• Males or Females.
• Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

• Patients younger than 19 years old or older than 40 years old.
• Pregnancy.
• Disabilities.
• Systemic disease or severe medical complications.
• Allergic history concerning methacrylate.
• Rampant caries.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups

conventional group

Active Comparator group

Description:

Conventional resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant is administrated

Treatment:

Combination Product: 3M™ Clinpro™ Sealant.

bioactive group

Experimental group

Description:

Bioactive Pits \& fissures sealant BioCoat® by Premier®.

Treatment:

Combination Product: BioCoat® by Premier®.