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

Hacettepe University

Status: Enrolling

Conditions: Caries Class I; Caries, Dental

Treatments: Device: GIC; Device: Giomer; Device: SDF

Study type: Interventional

Funder types: Other

Identifiers

NCT03872986

Caries sealing

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

SDF+Giomer

Experimental group

Description:

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

Treatment:

Device: SDF

Device: Giomer

Giomer only

Experimental group

Description:

Beautifil II dental restorative material

Treatment:

Device: Giomer

SDF+GIC

Experimental group

Description:

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

Treatment:

Device: SDF

Device: GIC

GIC only

Experimental group

Description:

Equia forte dental restorative material

Treatment:

Device: GIC