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

NCT07115290 | Completed

• 2 other identifiers: 612-SBKAEKTİTCK-2023-067
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries; Fissure Sealants; Permanent Molars; Child; Healthy Volunteers

Keywords

Dental caries; Fissure sealant; Glass ionomer; Resin-based sealant; Moisture-tolerant; Retention; Permanent molar; Children; Split-mouth design; Randomized clinical trial; Marginal adaptation; USPHS criteria

Outcome Measures

Primary Outcomes (1)

• Sealant retention

  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.

  1, 6, 12, 18, and 24 months

Secondary Outcomes (3)

• Marginal adaptation

  1, 6, 12, 18, and 24 months

• Marginal discoloration

  1, 6, 12, 18, and 24 months

• Presence of caries

  1, 6, 12, 18, and 24 months

Study Arms (2)

Glass Ionomer Sealant Arm

ACTIVE COMPARATOR

In this arm, a high-viscosity glass ionomer-based fissure sealant (Fuji Triage™ Capsule, GC Corporation, Tokyo, Japan) was applied to one of the newly erupted permanent first molars of each participant using a split-mouth design.

Device: Glass ionomer-based fissure sealant

Resin-Based Sealant Arm

ACTIVE COMPARATOR

In this arm, a moisture-tolerant resin-based fissure sealant (UltraSeal XT® Hydro, Ultradent Products Inc., South Jordan, UT, USA) was applied to the contralateral newly erupted permanent first molar of the same participant, using the split-mouth method.

Device: Resin-based fissure sealant

Interventions

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).

Also known as: Fuji Triage, Glass ionomer fissure sealant, GC Fuji Triage, GIC sealant

Glass Ionomer Sealant Arm

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).

Also known as: UltraSeal XT Hydro, Moisture-tolerant resin sealant, Hydrophilic sealant

Resin-Based Sealant Arm

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulcin Bulut: lead

Study Sites (1)

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

Izmir, İzmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Gulcin F Bulut, DDS, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, DDS, PhD

Model Details: This study employed a split-mouth crossover design in which each participant received both interventions. One first permanent molar on the right or left side of the same dental arch was sealed with a glass ionomer-based sealant, while the contralateral molar on the opposite side of the same arch received a moisture-tolerant resin-based sealant. This design minimizes inter-subject variability and allows for a direct comparison within the same oral environment.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: April 10, 2023
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)