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

March 12, 2021 updated by: Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Zafer Cehreli, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caries sealing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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