Glass Ionomer-Based Fissure Sealants in Children (Sealant)

January 30, 2026 updated by: Ebru KUCUKYİLMAZ, Izmir Katip Celebi University

Retention and Caries-Preventive Outcomes of Glass Ionomer-Based Fissure Sealants in Children: A 24-Month Split-Mouth Randomized Controlled Trial

This study aimed to comparatively evaluate the 24-month clinical retention performance and caries-preventive efficacy of three glass ionomer-based fissure sealants with different compositions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aimed to comparatively evaluate the 24-month clinical retention performance and caries-preventive efficacy of three glass ionomer-based fissure sealants with different compositions.

This randomized, controlled, double-blind, split-mouth clinical trial was conducted with approval from the Medhical Ethics Committee of İzmir Kâtip Çelebi University (14/100) and registered at ClinicalTrials.gov (NCT07110701). The study included 200 healthy children (ASA I), aged 6-12 years, with moderate caries risk. A total of 400 sealants were applied to the two fully erupted mandibular first molars of each participant. Following randomization, one molar received GC Fuji Triage (high-fluoride containing/control), while the contralateral molar received either GC Fuji VII EP (CPP-ACP-containing) or GCP Glass Seal (nano-fluorohydroxyapatite-containing). Applications were performed by a single clinician in accordance with manufacturers' instructions. Patients were evaluated at 3-, 6-, 12-, 18-, and 24-months. Retention, marginal integrity, marginal discoloration, and secondary caries were assessed using modified USPHS criteria. Occlusal caries progression was monitored via ICDAS-II codes and DIAGNOdent measurements

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The study comprised 200 healthy children aged between 6 and 12 years, ASA class I (American Society of Anesthesiologists),
  • 27 who were determined to exhibit cooperative behavior with a score of 3 or 4 on the Frankl Behavior Rating Scale.
  • All participants had fully erupted lower first permanent molars on both sides which required the application of pit and fissure sealants.
  • The inclusion criteria were based on the International Caries Detection and Assessment System II (ICDAS II) criteria,28 including deep and retained pits and fissures, no restorations, and no evidence of caries lesions.
  • The teeth were examined using the caries diagnosis device (DIAGNOdent pen 2190, KaVo, USA); readings of ≤ 15 were included in the study as well.

Exclusion Criteria:

  • Participants with special needs or systemic disease (ASA classification II or higher),
  • requiring emergency dental care,
  • suffering from a severe gag reflex or
  • an allergy to latex,
  • exhibiting uncooperative behavior (Frankl Score 1 or 2),
  • exhibiting molars with anomalies of the enamel/dentin, or
  • unable to attend follow-up appointments were excluded from the study.
  • A bitewing radiograph was used to assess teeth suspected of having caries on their proximal surfaces, and those with caries were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPP-ACP-containing fissure sealant
In this group, one mandibular molar was treated with a high-fluoride glass ionomer-based fissure sealant (Fuji Triage, GC Corporation, Tokyo, Japan; control group), while the contralateral molar was treated with a CPP-ACP-containing fissure sealant (Fuji VII EP, GC Corporation, Tokyo, Japan)
Other: Retention of Fissure Sealants
Other: Retention of the fissure sealants evaluated Description: Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
Experimental: Nano-fluorohydroxyapatite-containing fissure sealant
In this group, one mandibular molar was treated with a high-fluoride glass ionomer-based fissure sealant (Fuji Triage, GC Corporation, Tokyo, Japan; control group), while the contralateral molar was treated with nano-fluorohydroxyapatite-containing fissure sealant (GCP Glass Seal, GCP Dental, Vianen, The Netherlands)
Other: Retention of Fissure Sealants
Other: Retention of the fissure sealants evaluated Description: Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention rates of fissure sealants
Time Frame: The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, 18-, and 24 month follow-up visits.
Following classification system was employed for the retention evaluation of the sealants: 1 = complete retention; 2 = partial loss; or 3 = complete loss.
The evaluation of pit-and-fissure sealants was conducted to record the presence of caries lesions and sealant retention at 6-, 12-, 18-, and 24 month follow-up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Investigators

  • Study Chair: EBRU KUCUKYİLMAZ, PROFESSOR, İzmir Katip Çelebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014/100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study plan will be shared

IPD Sharing Time Frame

The plan will be shared following the completion of the research paper (approximately 1 month)

IPD Sharing Access Criteria

De-identified individual participant data (IPD) will be made available upon reasonable request following publication of the main results, in accordance with institutional and ethical regulations. Access will be granted to qualified researchers for non-commercial purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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