Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up
NCT ID: NCT07136051
Last Updated: 2025-08-28
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-03
2027-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Group A: Acid etching + sealant
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%.
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.
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.
Group B: Acid etching + deproteinization + sealant
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.
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.
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.
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.
Group C: Acid etching + bonding agent + sealant
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).
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
8 Years
15 Years
ALL
Yes
Sponsors
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Inonu University
OTHER
Handan Vural
OTHER
Responsible Party
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Handan Vural
Assistant Professor
Principal Investigators
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handan vural, Assistant Professor
Role: STUDY_CHAIR
Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
Locations
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Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University
Battalgazi, Malatya, Turkey (Türkiye)
Countries
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References
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Khare M, Suprabha BS, Shenoy R, Rao A. Evaluation of pit-and-fissure sealants placed with four different bonding protocols: a randomized clinical trial. Int J Paediatr Dent. 2017 Nov;27(6):444-453. doi: 10.1111/ipd.12281. Epub 2016 Dec 26.
Nair SM, Nene KS, Tirupathi S, Mathur AA, Khan HA, Godbole NM, Patil PP, Deolikar SA. Effect of Enamel Deproteinization Prior to Etching on the Clinical Performance of Resin-based Pit and Fissure Sealants: A Split-mouth Double-blinded Pilot Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Feb;18(2):119-125. doi: 10.5005/jp-journals-10005-3051. Epub 2025 Mar 20.
Other Identifiers
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7706
Identifier Type: -
Identifier Source: org_study_id
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