Pit and Fissure Sealant
Conditions
Keywords
dental sealant, pit and fissure sealant, fissure sealant, Bioactive dental sealant, Tooth sealant, Fissure sealants, Dental sealants, Pit sealants
Brief summary
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Detailed description
New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions. With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
Interventions
OTHERBioCoat® by Premier®
BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.
OTHERUltraSeal XT™ plus by Ultradent
UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Blinding to participants : will not know either the intervention or the comparator will be applied to their teeth Blinding to investigator: covering the 2 syringes with opaque seal to avoid performance bias Blinding to outcomes assessor: to overcome detection bias
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria of participants: * Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries. * Co-operative patients approving to part- icipate in the trial. * Good oral hygiene. * Inclusion Criteria of teeth: * Caries susceptible occlusal pits and fissures. * Intact contact with opposing teeth. * Teeth with no previous restorations in other surfaces.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of sealant | 1 year | rate of sealant loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries incidence | 1 year | Rate of caries progression |
Contacts
Primary ContactSamaa Salah, Msc
Outcome results
None listed