NCT07136051

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Handan Vural · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fissure Sealant
• Deproteinization
• Bonding Agent
• Molar Teeth
• Etching

Interventions

Type	Name	Description
PROCEDURE	Ethcing	Etching: After polishing all teeth included in the study with a polishing brush, Vococid (Voca, Germany) etching gel will be applied to the surface and left for 15 seconds, then rinsed and dried.
PROCEDURE	Deproteinization	The teeth randomly assigned to Group B will receive 5.25% NaOCl applied with a sterile cotton pellet for 60 seconds after acid etching, followed by rinsing and drying.
PROCEDURE	Bonding	The teeth randomly assigned to Group C will receive Futurabond® M+ (Voco, Germany) applied with a brush following acid etching. After gently drying with air for 5 seconds, the bonding step will be completed by light-curing for 10 seconds.
PROCEDURE	Application of resin-based fissure sealant	After completing the pretreatment steps for all groups, Grandio Seal (Voco GmbH, Germany) will be applied to the pits and fissures on the tooth surface and light-cured for 20 seconds. The procedure will be completed after checking the surface.

Timeline

• Start date: 2025-08-03
• Primary completion: 2027-02-01
• Completion: 2027-05-01
• First posted: 2025-08-22
• Last updated: 2025-08-28

Locations

1 site across 1 country: Turkey (Türkiye)