NCT03872986

Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride

Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Caries, Dental
• Caries Class I

Interventions

Type	Name	Description
DEVICE	SDF	Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)
DEVICE	Giomer	Beautifil II dental restorative material
DEVICE	GIC	Equia forte dental restorative material

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2019-03-13
• Last updated: 2021-03-15

Locations

2 sites across 1 country: Turkey (Türkiye)