Clinical Performance of Restorative Materials in Primary Teeth
Primary Purpose
Caries; Dentin, Dental Caries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Compomer
RMGIC
Giomer
Amalgam
Sponsored by
About this trial
This is an interventional treatment trial for Caries; Dentin focused on measuring restorative materials, primary teeth, children
Eligibility Criteria
Inclusion Criteria:
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth that have caries lesions extending no more than the outher half of dentin radiographically
Exclusion Criteria:
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients who are uncooperative
- 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 or anomalies
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Compomer
RMGIC
Giomer
Amalgam
Arm Description
Adhesive agent+Compomer
Primer+RMGIC
Adhesive Agent+ Giomer
Amalgam
Outcomes
Primary Outcome Measures
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03037814
Brief Title
Clinical Performance of Restorative Materials in Primary Teeth
Official Title
Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 28, 2021 (Anticipated)
Primary Completion Date
July 25, 2026 (Anticipated)
Study Completion Date
March 25, 2027 (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 dental restorative materials in Class II cavities of primary molar teeth
Detailed Description
Restorations will be placed on four primary molar teeth with proximal 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: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. 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; Dentin, Dental Caries
Keywords
restorative materials, primary teeth, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compomer
Arm Type
Other
Arm Description
Adhesive agent+Compomer
Arm Title
RMGIC
Arm Type
Other
Arm Description
Primer+RMGIC
Arm Title
Giomer
Arm Type
Other
Arm Description
Adhesive Agent+ Giomer
Arm Title
Amalgam
Arm Type
Other
Arm Description
Amalgam
Intervention Type
Device
Intervention Name(s)
Compomer
Intervention Description
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
Intervention Type
Device
Intervention Name(s)
RMGIC
Intervention Description
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
Intervention Type
Device
Intervention Name(s)
Giomer
Intervention Description
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Intervention Type
Device
Intervention Name(s)
Amalgam
Intervention Description
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
Primary Outcome Measure Information:
Title
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
Description
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients and parent of the patients who accept to participate and sign the informed consent
Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
Teeth that have healthy lamina dura and periodontal ligament
Teeth that have caries lesions extending no more than the outher half of dentin radiographically
Exclusion Criteria:
Patients and parent of the patients who don't accept to participate and sign the informed consent
Teeth that are previously restored
Patients who are uncooperative
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 or anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zafer C Cehreli, DDS, PhD
Phone
00905353197969
Email
zcehreli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beste Ozgur, DDS, PhD
Phone
005072657769
Email
besteisbitiren@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafer C Cehreli, DDS, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/26161601
Available IPD/Information Identifier
26161601
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/19953810
Available IPD/Information Identifier
19953810
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/12542617
Available IPD/Information Identifier
12542617
Learn more about this trial
Clinical Performance of Restorative Materials in Primary Teeth
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