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Clinical Trial Summary

The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth


Clinical Trial Description

Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials. Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan) The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03872986
Study type Interventional
Source Hacettepe University
Contact Zafer C Cehreli
Phone 00905353197969
Email zcehreli@gmail.com
Status Recruiting
Phase N/A
Start date February 4, 2021
Completion date June 1, 2024

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