Clinical Trial

Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Objective: This study aims to evaluate the effect of two different pretreatment protocols-enamel deproteinization and bonding agent application-on the one-year survival of fissure sealants applied to permanent first molars in children. Background: Dental caries is a preventable yet highly prevalent multifactorial disease. Deep pits and fissures are particularly susceptible to caries development, especially in newly erupted molars. Although fissure sealants are considered one of the most effective preventive methods, their clinical success is largely dependent on long-term retention. Contamination of etched enamel surfaces with saliva or gingival fluid is a primary cause of sealant failure. To improve sealant adhesion, several pretreatment methods have been suggested, including bonding agents and enamel deproteinization. Methods: This randomized, controlled, double-blind clinical trial with a split-mouth design was conducted on healthy children aged 7-14 years. Each child contributed at least three permanent first molars to the study, randomly assigned to one of three groups: Group A - Acid etching + sealant; Group B - Acid etching + deproteinization + sealant; Group C - Acid etching + bonding agent + sealant. Clinical evaluations were performed at 3, 6, and 12 months using visual and tactile methods. Sealant retention, caries incidence, and marginal discoloration were recorded based on standardized criteria. Results \& Conclusion: This study seeks to clarify whether bonding agent or deproteinization pretreatment significantly improves sealant retention and reduces caries incidence compared to the conventional approach. Findings may contribute to defining the most effective clinical protocol for fissure sealant application, ultimately enhancing caries prevention and long-term treatment success in pediatric dental care.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-19.
Trial Details
NCT Number NCT07136051
Lead Sponsor Handan Vural
Collaborators: Inonu University
Conditions Fissure Sealant, Deproteinization, Bonding Agent, Molar Teeth, Etching
Enrollment 40 participants
Start Date 2025-08-03
Primary Completion 2027-02 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-08-28