One-year Survival of Fissure Sealants in Immature Permanent Molars

Handan Vural

Status: Not yet enrolling

Conditions: Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption Stages

Treatments: Procedure: Preventive pit and fissure sealant application

Study type: Interventional

Funder types: Other

Identifiers

NCT07143253

7699

Details and patient eligibility

About

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.

Full description

This study is designed to compare the 12-month survival rates of GC Fuji Triage (glass ionomer-based) and UltraSeal XT™ hydro™ (Hydrophilic Pit and Fissure Sealant) fissure sealants applied to partially erupted permanent second molars. The research will be conducted using a split-mouth, double-blind, randomized, and controlled design, aiming to provide a high level of scientific reliability through its prospective nature.

Blinding of both participants and evaluators is intended to minimize observational bias and enhance the validity of the results. The study is expected to provide evidence-based data that will guide clinicians in material selection and contribute to the existing literature in the field.

Furthermore, by being reported in accordance with the CONSORT guidelines, the study will meet international standards for clinical research reporting.

Inclusion Criteria:

Healthy children aged 10 to 15 years. Partially erupted, caries-free or demineralized fissures with ICDAS scores 1-2 on permanent second molars, confirmed by clinical and radiographic examination.

Children who demonstrate cooperative behavior, scoring 3 or 4 on the Frankl Behavior Rating Scale.

An oral hygiene score (OHI-S) ≤ 3. Written informed consent obtained from a parent or legal guardian prior to participation in the study.

Exclusion Criteria:

Fully erupted or completely impacted teeth. Teeth with severe hypoplasia, hypomineralization, presence of extensive restorations, or cavitated carious lesions.

Children with a history of systemic disease or long-term medication use. Known allergies to resin-based or glass ionomer materials. Presence of parafunctional habits (e.g., bruxism, nail biting, etc.).

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 light-cured for 20 seconds using an LED curing light.

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 evaluated by two independent blinded evaluators according to modified USPHS criteria:

Sealant retention (Complete / Partial / Total loss) Marginal discoloration Development of secondary caries

In cases where sealant loss is observed during follow-up, the material will be reapplied to the affected tooth; however, that tooth will not be included in subsequent evaluations.

Participants will not experience any disadvantage or harm due to any adverse outcome related to the materials used.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 10-15 years.
• Partially erupted second permanent molars 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

• Fully erupted or completely impacted teeth.
• 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 2 patient groups

Gruop A:UltraSeal XT hydro sealant / hydrophillic pit and fissure sealent

Active Comparator group

Description:

The presence of moisture and saliva-contamination during the placement of the sealant compromise the quality of adhesion at the sealant-enamel interface, which impacts the ongoing resistance to microleakage of microorganisms. Hydrophilic sealants, which bond effectively to moist enamel surfaces, present a distinct advantage in paediatric dentistry where patient-compliance, isolation, and moisture-control can be particularly challenging.UltraSeal XT® hydro™ is a new moisture-tolerant, self-adhesive, light-cured, acrylate-based, hydrophilic pit, and fissure sealant which has been developed by Ultradent Products, USA. The sealant comprises a 53 wt% mixture of inorganic filler particles that confer radiopacity. This material is reported to "chase" moisture into the pits and fissures, thus eliminating moisture-related failure associated with hydrophobic sealants

Treatment:

Procedure: Preventive pit and fissure sealant application

Gruop B: GC Fuji Triage- glassionomer pit and fissure sealent

Active Comparator group

Description:

Glass ionomer (GI)-based fissure sealants are considered a valuable treatment alternative, particularly in pediatric dentistry for patients at high risk of caries, due to their ability to chemically bond to dental tissues, release fluoride, exhibit biocompatibility, provide antibacterial effects, and promote the remineralization of hydroxyapatite crystals. The self-bonding, high-fluoride-releasing GC Fuji TRIAGE® is frequently reported in the literature as a fissure sealant, particularly for immature and partially erupted teeth. The use of glass ionomers as fissure sealants is especially emphasized in cases where isolation is difficult.

Treatment:

Procedure: Preventive pit and fissure sealant application