Comparative Evaluation of Glass Ionomer and Resin-Based Fissure Sealants on Newly Erupted Permanent First Molars: A 24-Month Randomized Clinical Trial (FISSURE24)

Gulcin Bulut

Status: Completed

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

Treatments: Device: Glass ionomer-based fissure sealant; Device: Resin-based fissure sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT07115290

612-SBKAEK

TİTCK-2023-067 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 6 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Glass Ionomer Sealant Arm

Active Comparator group

Description:

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.

Treatment:

Device: Glass ionomer-based fissure sealant

Resin-Based Sealant Arm

Active Comparator group

Description:

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.

Treatment:

Device: Resin-based fissure sealant