Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Caries, Dental
- Sponsor
- Cairo University
- Enrollment
- 38
- Primary Endpoint
- Retention of sealant
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Alaa Fathi Abdelsalam
principle investigator
Cairo University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Retention of sealant
Time Frame: one year
rate of sealant loss
Secondary Outcomes
- Caries incidence(one year)