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

Handan Vural

Status: Active, not recruiting

Conditions: Molar Teeth; Fissure Sealant; Etching; Bonding Agent; Deproteinization

Treatments: Procedure: Bonding; Procedure: Application of resin-based fissure sealant; Procedure: Deproteinization; Procedure: Ethcing

Study type: Interventional

Funder types: Other

Identifiers

NCT07136051

7706

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 8-15 years.
• Fully erupted or completely impacted teeth that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-2.
• Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or 4.
• Oral Hygiene Index (OHI-S) score ≤ 3
• Written informed consent obtained from the parent or legal guardian.

Exclusion criteria

• Partially erupted second permanent molars
• Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
• History of systemic disease or long-term medication use.
• Known allergy to resin-based or glass ionomer materials.
• Presence of parafunctional habits.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Group A: Acid etching + sealant

Active Comparator group

Description:

Sealant application is a preventive conservative approach involving the introduction of sealants into the pits and fissures of caries prone teeth; this sealant then bonds to the tooth micromechanically, providing a physical barrier that keeps bacteria away from their source of nutrients. Acid pretreatment of the enamel to enhance retention is considered a standard procedure prior to the application of resin-based fissure sealants. Currently, the most commonly used phosphoric acid concentrations are 35% and 37%.

Treatment:

Procedure: Ethcing

Procedure: Application of resin-based fissure sealant

Group B: Acid etching + deproteinization + sealant

Active Comparator group

Description:

The use of phosphoric acid is a well-accepted, conventional method used to create micro-porosities, which are the key in providing sealant retention. However, organic remnants as well as fissure morphology and aprismatic enamel structure can decrease etching ability and thus prevent adequate adhesion.Conventional phosphoric acid can only demineralize the inorganic component of enamel and cannot completely remove the protein content within the enamel. Some proteins are also embedded within the enamel crystals. The inadequate penetration of resin into enamel may also result from the Type 3 etching pattern observed after conventional etching. Studies have shown that after using sodium hypochlorite to remove enamel proteins, Type 1 and Type 2 etching patterns are more frequently observed. The literature indicates that the enamel deproteinization technique with sodium hypochlorite is an effective method for removing organic material from the occlusal enamel surfaces of teeth.

Treatment:

Procedure: Ethcing

Procedure: Deproteinization

Procedure: Application of resin-based fissure sealant

Group C: Acid etching + bonding agent + sealant

Active Comparator group

Description:

Various methods for preparing fissures, such as pumice prophylaxis, bonding agents, lasers, air abrasion, and sodium hypochlorite deproteinization, have been recommended to improve sealant retention The use of adhesive systems prior to fissure sealant application had a positive effect on increasing penetration and improving the retention rate. It also appears that the use of bonding-agents that involve a separate acid-etching step (fourth and fifth generations) provides better sealant retention than self-etching adhesives (sixth and seventh generations).

Treatment:

Procedure: Ethcing

Procedure: Application of resin-based fissure sealant

Procedure: Bonding