Caries; Initial
Conditions
Brief summary
The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Detailed description
SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions. With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.
Interventions
OTHERBioCoat® by Premier®
Bioactive pits and fissure sealant
Fluoride releasing pits and fissure sealant
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Patients with bilateral initial carious fissures in molars showing no signs of caries. * Co-operative patients approving to participate in the trial.
Exclusion criteria
* Sound fissures. * Pregnancy. * Disabilities. * Systemic disease or severe medical complications. * Rampant caries. * Heavy smoking. * Xerostomia. * Lack of compliance. * Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of sealant | 2 years | rate of sealant loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries incidence | 2 years | Rate of caries progression |
Countries
Egypt
Outcome results
None listed