One-year Survival of Fissure Sealants in Immature Permanent Molars

Condition(s) studied

Investigational drug(s) / intervention(s)

Preventive pit and fissure sealant application: Preventive pit and fissure sealant application is a preventive procedure involving the use of flowable resin-based or glass ionomer-based materials to physically cover the occlusal surfaces of teeth, particularly in pits and fissures at high risk of caries development. This barrier prevents plaque accumulation and protects the enamel surface. In this study, no procedures beyond the routine clinical application of the materials will be performed. However, partially erupted permanent teeth with challenging isolation will be specifically selected. Both materials will be applied using a split-mouth design to the teeth of the same participant. This approach will allow for an effective and comparative evaluation of the clinical retention of the material.

Study summary

Dental caries remains one of the most prevalent oral diseases today. The risk of caries development is highest during the first few years following tooth eruption. Therefore, preventive strategies for dental caries continue to be of great importance.

In particular, permanent second molars are highly susceptible to caries during their eruption phase, as the enamel has not yet completed its physiological maturation. This vulnerability is especially pronounced in partially erupted teeth, where the risk of caries formation increases significantly in the absence of effective preventive measures.

In this context, fissure sealants are widely used as a preventive approach, particularly in children and adolescents, due to their proven efficacy in caries prevention. In this study, the 12-month clinical performance of resin-based hydrophilic and glass ionomer-based fissure sealants applied to partially erupted permanent first and/or second molars will be evaluated comparatively.

Informed consent will be obtained from all participants prior to their inclusion in the study. The aim of this research is to provide scientific evidence to support material selection in the field of preventive dentistry.

Previous studies (Ahovuo-Saloranta et al., 2013) have emphasized that long-term clinical success rates have a direct impact on material selection, highlighting the importance of conducting prospective clinical trials.

This study is designed as a split-mouth, double-blind, randomized, controlled clinical trial. The reporting of the study will adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University.

Healthy children aged between 7 and 15 years will be included in the study. Randomization will be performed using a computer-assisted program. Two different fissure sealants will be applied to different teeth in each patient.

Application Procedure:

All fissure sealants will be applied by a single experienced operator in accordance with the manufacturer's instructions.

Resin-based sealants will be polymerized for 20 seconds using an LED light source.

Group A: Hydrophilic fissure sealant

Group B: Glass ionomer-based fissure sealant

Evaluation Time Points:

Immediately after application

At 3 months

At 6 months

At 12 months

The following parameters will be assessed by two independent blinded evaluators according to modified USPHS criteria:

Retention of the fissure sealant (Complete / Partial / Total loss)

Marginal discoloration

Development of secondary caries

Data will be entered into Microsoft Excel and analyzed using SPSS software. A p-value of \< 0.05 will be considered statistically significant.

Eligibility

Primary outcome measure(s)

• Modified Simonsen Criteria — 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
• Edge Integrity Evaluation Criteria — 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
• Marginal Coloration Evaluation Criteria — 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.
• Anatomical Form Evaluation Criteria — 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. 2. a 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

Trial sites (1)

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