Caries, Dental
Conditions
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.
Interventions
COMBINATION_PRODUCTBioCoat® by Premier®.
Bioactive pits and fissure sealant
COMBINATION_PRODUCT3M™ Clinpro™ Sealant.
conventional pits and fissure sealant
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of sealant | one year | rate of sealant loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries incidence | one year | rate of caries initiation |
Outcome results
None listed