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

Hacettepe University100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Caries, Dental Caries Class I

Interventions

SDFDEVICE

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

GiomerDEVICE

Beautifil II dental restorative material

GICDEVICE

Equia forte dental restorative material

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Hacettepe university

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

The US Public Health Service criteria for secondary caries on restorations

A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries

Time frame: 2 years

The US Public Health Service criteria for retention of restorations

Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration

Time frame: 2 years

The US Public Health Service criteria for marginal discoloration on restorations

Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction

Time frame: 2 years

The US Public Health Service criteria for marginal adaptation on restorations

Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin

Time frame: 2 years

The US Public Health Service criteria for surface roughness on restorations

Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked

Time frame: 2 years

The US Public Health Service criteria for anatomical form on restorations

A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement

Time frame: 2 years

Central Contacts

Zafer C Cehreli

CONTACT

00905353197969 zcehreli@gmail.com

Gizem Erbas Unverdi

CONTACT

00905052805736 erbasgizem@yahoo.com

Data from ClinicalTrials.gov

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