One-year Survival of Fissure Sealants in Immature Permanent Molars

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.

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.