Izmir Katip Celebi University
Izmir, 35640, Turkey (Türkiye)
NCT Number: NCT07388472
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.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Izmir, 35640, Turkey (Türkiye)
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Izmir Katip Celebi University
Other
Retention and Caries-Preventive Outcomes of Glass Ionomer-Based Fissure Sealants in Children: A 24-Month Split-Mouth Randomized Controlled Trial
Acronym: Sealant
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