Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up
NCT07136051 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-08-28
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
- 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.
Sponsors & Collaborators
-
Inonu University
collaborator OTHER -
Handan Vural
lead OTHER
Principal Investigators
-
handan vural, Assistant Professor · Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 8 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-03
- Primary Completion
- 2027-02-28
- Completion
- 2027-05-31
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride
NCT03872986 ·Status: UNKNOWN ·Phase: NA
-
Clinical Evaluation of Two Different Pit and Fissure Sealants
NCT06776471 ·Status: RECRUITING ·Phase: NA
-
Effect of Resin Infiltration on Hypersensitivity and Satisfaction in Children With Enamel Defects
NCT07118111 ·Status: COMPLETED ·Phase: NA
-
The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth
NCT07003958 ·Status: RECRUITING ·Phase: NA
-
The Effect of Different Deproteinising Agents on the Clinical Success of Fissure Sealants in Permanent Teeth
NCT06988098 ·Status: RECRUITING ·Phase: NA
-
Use of Fissure Sealants on Primary Molars
NCT01438866 ·Status: COMPLETED ·Phase: PHASE4
-
Early Treatments for Preventing Occlusal Caries Lesions
NCT05969756 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
NCT02896556 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
NCT01446107 ·Status: COMPLETED ·Phase: NA
-
Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars
NCT06771362 ·Status: COMPLETED ·Phase: NA
-
Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia in MIH-Affected Molars
NCT07326241 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Sealants in Molars Affected by Molar-Incisor Hypomineralization
NCT02794116 ·Status: COMPLETED ·Phase: NA
-
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth
NCT01829334 ·Status: COMPLETED ·Phase: PHASE2
-
Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention
NCT04163354 ·Status: UNKNOWN ·Phase: NA
-
Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives
NCT02897089 ·Status: UNKNOWN ·Phase: NA
-
Occlusal Caries Management in First Permanent Molars in Child Dental Care
NCT03315312 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
NCT05838469 ·Status: UNKNOWN ·Phase: NA
-
Follow-up of Indirect Restorations Luted With Different Adhesive Resin Cement
NCT05551481 ·Status: COMPLETED ·Phase: NA
-
Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars
NCT03005405 ·Status: UNKNOWN ·Phase: NA
-
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
NCT05202665 ·Status: UNKNOWN ·Phase: NA
-
Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study
NCT07144605 ·Status: COMPLETED ·Phase: NA
-
Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber
NCT04612543 ·Status: COMPLETED ·Phase: NA
-
Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions
NCT03415412 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Sealing of Occlusal Dentin Caries in Primary Molars.
NCT05475145 ·Status: COMPLETED ·Phase: NA
-
Clinical Performance of Posterior Indirect Adhesive Restorations
NCT04838483 ·Status: UNKNOWN ·Phase: NA