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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-04

Study Completion Date

2024-06-01

Brief Summary

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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

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Detailed Description

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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

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Caries, Dental Caries Class I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SDF+Giomer

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material

Group Type EXPERIMENTAL

SDF

Intervention Type DEVICE

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

Giomer

Intervention Type DEVICE

Beautifil II dental restorative material

Giomer only

Beautifil II dental restorative material

Group Type EXPERIMENTAL

Giomer

Intervention Type DEVICE

Beautifil II dental restorative material

SDF+GIC

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte

Group Type EXPERIMENTAL

SDF

Intervention Type DEVICE

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

GIC

Intervention Type DEVICE

Equia forte dental restorative material

GIC only

Equia forte dental restorative material

Group Type EXPERIMENTAL

GIC

Intervention Type DEVICE

Equia forte dental restorative material

Interventions

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SDF

Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)

Intervention Type DEVICE

Giomer

Beautifil II dental restorative material

Intervention Type DEVICE

GIC

Equia forte dental restorative material

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients and parents of the patients who accept to participate and sign the informed consent.
* Patients who have at least four first and/or second primary molars that require class I restorations
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth that have caries lesions not extending to the pulp radiographically
* Patients whose first molar teeth are in occlusion

Exclusion Criteria

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth which need endodontic treatment
* Teeth that have caries more than one surface
* Teeth that are previously restored
* Patients who are not cooperative for the dental procedure
* Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
* Patients who have bruxism, skeletal or dental malocclusion
* Teeth that have developmental defects/anomalies or discoloration
* Patients who have allergies to resin based restorative materials

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes