Clinical trial NCT03872986: Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride
Official title: Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries, Dental
Caries Class I
Keywords: primary teeth
silver diamine fluoride
caries sealing
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The US Public Health Service criteria for secondary caries on restorations
timeFrame: 2 years
measure: The US Public Health Service criteria for retention of restorations
timeFrame: 2 years
measure: The US Public Health Service criteria for marginal discoloration on restorations
timeFrame: 2 years
measure: The US Public Health Service criteria for marginal adaptation on restorations
timeFrame: 2 years
measure: The US Public Health Service criteria for surface roughness on restorations
timeFrame: 2 years
measure: The US Public Health Service criteria for anatomical form on restorations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Ankara
country: Turkey
facility: Hacettepe university
Study officials:
affiliation: Hacettepe University
name: Zafer Cehreli
role: PRINCIPAL_INVESTIGATOR
References: