Glass Ionomer-Based Fissure Sealants in Children

Izmir Katip Celebi University

Status: Completed

Conditions: Fissure Sealant

Treatments: Other: Retention of Fissure Sealants

Study type: Interventional

Funder types: Other

Identifiers

NCT07388472

2014/100

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

CPP-ACP-containing fissure sealant

Experimental group

Description:

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)

Treatment:

Other: Retention of Fissure Sealants

Nano-fluorohydroxyapatite-containing fissure sealant

Experimental group

Description:

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)

Treatment:

Other: Retention of Fissure Sealants