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

Sponsor

Hacettepe University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03872986

Collaborator

(none)

100

Enrollment

Locations

Arms

39.9

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental Caries Class I	Device: SDF Device: Giomer Device: GIC	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 4, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SDF+Giomer Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material	Device: SDF Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) Device: Giomer Beautifil II dental restorative material
Experimental: Giomer only Beautifil II dental restorative material	Device: Giomer Beautifil II dental restorative material
Experimental: SDF+GIC Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte	Device: SDF Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) Device: GIC Equia forte dental restorative material
Experimental: GIC only Equia forte dental restorative material	Device: GIC Equia forte dental restorative material

Outcome Measures

Primary Outcome Measures

The US Public Health Service criteria for secondary caries on restorations [2 years]
A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries
The US Public Health Service criteria for retention of restorations [2 years]
Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration
The US Public Health Service criteria for marginal discoloration on restorations [2 years]
Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction
The US Public Health Service criteria for marginal adaptation on restorations [2 years]
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
The US Public Health Service criteria for surface roughness on restorations [2 years]
Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked
The US Public Health Service criteria for anatomical form on restorations [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey	06100
2	Hacettepe university	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

Principal Investigator: Zafer Cehreli, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03872986

Other Study ID Numbers:

Caries sealing

First Posted:

Mar 13, 2019

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Principal Investigator, Hacettepe University

primary teeth

silver diamine fluoride

caries sealing

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Mar 15, 2021