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

Primary Purpose

Caries, Dental, Caries Class I

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SDF
Giomer
GIC
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring primary teeth, silver diamine fluoride, caries sealing

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts 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

Sites / Locations

  • Hacettepe UniversityRecruiting
  • Hacettepe universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

SDF+Giomer

Giomer only

SDF+GIC

GIC only

Arm Description

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

Beautifil II dental restorative material

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

Equia forte dental restorative material

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2019
Last Updated
March 12, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03872986
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental, Caries Class I
Keywords
primary teeth, silver diamine fluoride, caries sealing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SDF+Giomer
Arm Type
Experimental
Arm Description
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material
Arm Title
Giomer only
Arm Type
Experimental
Arm Description
Beautifil II dental restorative material
Arm Title
SDF+GIC
Arm Type
Experimental
Arm Description
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte
Arm Title
GIC only
Arm Type
Experimental
Arm Description
Equia forte dental restorative material
Intervention Type
Device
Intervention Name(s)
SDF
Intervention Description
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)
Intervention Type
Device
Intervention Name(s)
Giomer
Intervention Description
Beautifil II dental restorative material
Intervention Type
Device
Intervention Name(s)
GIC
Intervention Description
Equia forte dental restorative material
Primary Outcome Measure Information:
Title
The US Public Health Service criteria for secondary caries on restorations
Description
A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries
Time Frame
2 years
Title
The US Public Health Service criteria for retention of restorations
Description
Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration
Time Frame
2 years
Title
The US Public Health Service criteria for marginal discoloration on restorations
Description
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
Title
The US Public Health Service criteria for marginal adaptation on restorations
Description
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
Title
The US Public Health Service criteria for surface roughness on restorations
Description
Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked
Time Frame
2 years
Title
The US Public Health Service criteria for anatomical form on restorations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zafer C Cehreli
Phone
00905353197969
Email
zcehreli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gizem Erbas Unverdi
Phone
00905052805736
Email
erbasgizem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafer Cehreli
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zafer C Cehreli, DDS, PhD
Phone
+903123052289
Email
zcehreli@gmail.com
First Name & Middle Initial & Last Name & Degree
Gizem Erbas Unverdi, DDS, PhD
Phone
+903123052280
Email
erbasgizem@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zafer C Cehreli, Prof
First Name & Middle Initial & Last Name & Degree
Gizem Erbas Unverdi, Research as.
First Name & Middle Initial & Last Name & Degree
Elif Ballikaya, Research as.
Facility Name
Hacettepe university
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gizem E Unverdi
Email
erbasgizem@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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