Skip to main content
OpenTrials
Completed

NCT Number: NCT07115290

Comparative Evaluation of Glass Ionomer and Resin-Based Fissure Sealants on Newly Erupted Permanent First Molars: A 24-Month Randomized Clinical Trial

This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. The study evaluates which material provides better retention, marginal adaptation, and protection against dental caries over a 24-month period.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry

Izmir, İzmir, 35340, Turkey (Türkiye)

About this study

This randomized, split-mouth, clinical study was designed to compare the clinical effectiveness of two different fissure sealant materials-glass ionomer-based (Fuji Triage™ Capsule) and moisture-tolerant resin-based (UltraSeal XT® Hydro)-in newly erupted permanent first molars in children aged 6-7 years.

The study evaluates the retention rates, marginal adaptation, marginal discoloration, and the ability of each material to prevent dental caries over a 24-month follow-up period. A total of 70 teeth from 35 children were sealed using a split-mouth design, ensuring that each participant received both types of sealants on contralateral molars. Clinical evaluations were performed at 1, 6, 12, 18, and 24 months using modified United States Public Health Service (USPHS) criteria.

The goal of the study is to determine whether the moisture-tolerant resin-based material offers a clinical advantage in terms of sealant retention and caries prevention in a partially erupted, moisture-challenged clinical environment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 6-7 years
  • Children who are systemically healthy and classified as ASA I and II16
  • Children whose parents and themselves have agreed to attend the study and follow-up visits throughout the study period
  • Children who have established oral hygiene habits

Exclusion criteria

  • Children whose caregivers did not sign the informed consent form, and patients who wished to withdraw or for whom the treatment protocol was not properly followed.
  • Children who have restorations, cavitated surfaces or developmental defects and hypoplasia on the permanent first molar teeth to be treated.
  • Medically compromised and children who need special treatment.
  • History of adverse reactions to any restorative materials.

Treatment and study plan

Glass ionomer-based fissure sealant

Device

A high-viscosity, self-curing glass ionomer sealant used for the occlusal surfaces of newly erupted permanent molars. This material releases fluoride and is moisture-tolerant during application. The product used in this study was Fuji Triage™ Capsule (GC Corporation, Japan).

Other names: Fuji Triage, Glass ionomer fissure sealant, GC Fuji Triage, GIC sealant

Resin-based fissure sealant

Device

A moisture-tolerant, light-cured resin-based fissure sealant designed for application to occlusal surfaces in partially erupted permanent molars. The material exhibits strong adhesion in moist conditions and forms a durable barrier against caries. The product used in this study was UltraSeal XT® Hydro (Ultradent Products Inc., USA).

Other names: UltraSeal XT Hydro, Moisture-tolerant resin sealant, Hydrophilic sealant

Primary outcomes

  1. Sealant retention

    Time frame: 1, 6, 12, 18, and 24 months

    Assessment of the retention of the fissure sealant material on the occlusal surface of the first permanent molars using modified USPHS criteria. Evaluated at 1, 6, 12, 18, and 24 months.

Secondary outcomes

  1. Marginal adaptation

    Time frame: 1, 6, 12, 18, and 24 months

    Evaluation of the marginal adaptation of the sealant to the tooth structure using modified USPHS criteria.

  2. Marginal discoloration

    Time frame: 1, 6, 12, 18, and 24 months

    Assessment of any marginal discoloration of the sealant using modified USPHS criteria.

  3. Presence of caries

    Time frame: 1, 6, 12, 18, and 24 months

    Detection of carious lesions on sealed occlusal surfaces throughout the follow-up period.

Sponsors and collaborators

Lead sponsor

Gulcin Bulut

Other

Registry information

Acronym: FISSURE24

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 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.

Published trials that share one or more normalized conditions with this study.