NCT07388472

Glass Ionomer-Based Fissure Sealants in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Fissure Sealant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-07-01
• Completion: 2020-01-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: Turkey (Türkiye)