Clinical Performance of Restorative Materials in Primary Teeth
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 25, 2027
March 15, 2021
March 1, 2021
4.8 years
January 29, 2017
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
5 years
Study Arms (4)
Compomer
OTHERAdhesive agent+Compomer
RMGIC
OTHERPrimer+RMGIC
Giomer
OTHERAdhesive Agent+ Giomer
Amalgam
OTHERAmalgam
Interventions
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.
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.
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zafer C Cehreli, DDS, PhD
Hacettepe University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
January 29, 2017
First Posted
January 31, 2017
Study Start
September 28, 2021
Primary Completion (Estimated)
July 25, 2026
Study Completion (Estimated)
March 25, 2027
Last Updated
March 15, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share