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NCT Number: NCT07136051

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

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.

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Key information

Conditions

Fissure Sealant Bonding Agent Deproteinization Etching Molar Teeth

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University

Battalgazi, Malatya, 44200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ethcing

Procedure

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

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Modified Simonsen Criteria

    Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

    Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries

  2. Edge Integrity Evaluation Criteria

    Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment

    0: The fissure sealant and tooth surface are intact and cannot be distinguished with a probe. 1: The edges of the fissure sealants can be distinguished with a probe. 2: There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa

  3. Marginal Coloration Evaluation Criteria

    Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

    0 No color change between fissure sealant and tooth. 1:Color change in only one area. 2:Color change in many areas. 3:Severe color change indicating leakage.

  4. Anatomical Form Evaluation Criteria

    Time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

    0 Consistent with and continuous with occlusal form and structure. 1 Change in anatomical form but all pits and fissures covered. 2a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant. 2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired. 3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins

Sponsors and collaborators

Lead sponsor

Handan Vural

Other

Collaborators

  • Inonu University

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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