Glass Ionomer-Based Fissure Sealants in Children

NCT07388472 | Completed

• 1 other identifier: 2014/100
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fissure Sealant

Keywords

caries; prevention; glass ionomer material; fissure sealant

Outcome Measures

Primary Outcomes (1)

• retention rates of fissure sealants

  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.

Study Arms (2)

CPP-ACP-containing fissure sealant

EXPERIMENTAL

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

Nano-fluorohydroxyapatite-containing fissure sealant

EXPERIMENTAL

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

Interventions

Retention of Fissure Sealants OTHER

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.

CPP-ACP-containing fissure sealant; Nano-fluorohydroxyapatite-containing fissure sealant

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The study comprised 200 healthy children aged between 6 and 12 years, ASA class I (American Society of Anesthesiologists),
• 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 teeth were examined using the caries diagnosis device (DIAGNOdent pen 2190, KaVo, USA); readings of ≤ 15 were included in the study as well.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35640, Turkey (Türkiye)

Location

Study Officials

• EBRU KUCUKYİLMAZ, PROFESSOR

  İZMİR KATIP CELEBI UNİVERSİTY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study was carried out as a double-blinded trial, whereby neither the patients nor the clinical evaluator was aware of what material was applied to each tooth. No blinding was done during the treatment period because all treatments were performed by one dentist. The randomization process was applied with two phases to ensure unbiased allocation of the fissure sealant materials to the participants. In the first phase of the randomization, which material groups (GC Fuji Triage -GCP Glass Seal/GC Fuji Triage-GC Fuji VII EP) would be applied to each patient was determined using a computer-generated randomization online tool (htpp//randomizer.org). In the second phase of the randomization, the allocation of the material to either the left or right mandibular molar of each participant was established through the coin toss method (heads or tails), and the opposing molar tooth was treated with the other material in accordance with the group designated by the first randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: randomized, controlled, double-blind, split-mouth design 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).

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 5, 2026
• Study Start: November 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The plan will be shared following the completion of the research paper (approximately 1 month)
• 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.

Locations

TU (1)