Investigation of Glass Carbomer Performance
12-Month Clinical Performance Evaluation of a Current Glass Carbomer Restorative System
1 other identifier
interventional
36
1 country
1
Brief Summary
The aim of this in vivo study was to evaluate the clinical 1 year follow-up of silica and flouroapatite reinforced glass carbomer filling material.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
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
Study Start
First participant enrolled
September 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2018
CompletedFirst Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 16, 2019
CompletedOctober 16, 2019
October 1, 2019
7 days
October 4, 2019
October 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of criterias
In this clinical study, the restorations were evaluated.Restorations were scored. using the terms Alpha, Bravo and Charlie.Alpha was used for restorations that were considered clinically successful; Bravo was used for the restorations with several deficiencies but requiring no replacement; and Charlie was used for the clinically unacceptable restorations where the restoration had to be replaced.End of the one-week there was no significant differences between restorative materials for all evaluation criterias, were mentioned in summary.
1 week
Secondary Outcomes (1)
Evaluation of criterias
6-months
Other Outcomes (1)
Evaluations of criterias
12-months
Study Arms (2)
Glass carbomer
ACTIVE COMPARATORTokuyama Estelite Posterior
ACTIVE COMPARATORInterventions
Detection of caries then restoration of cavities
Detection of caries then restoration of cavities
Eligibility Criteria
You may qualify if:
- years of age
- No systemic diseases
- Presence of molar / premolar teeth with occlusal and / or interface caries
- Lack of parafunctional habits such as clenching and grinding of teeth
- Lack of cooperation problems
- Accepted regular visits -
You may not qualify if:
- Any endodontic treatment or withdrawal indications (abscess, swelling and fistula complaints, palpation and percussion pain, spontaneous or night pain) 2- Teeth with congenital developmental defect 3- Teeth with pathological mobility 4- Teeth which do not have normal occlusion due to skeletal or pathological reasons 5- Lack of contact or opposite teeth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
- Bezmialem Vakif Universitycollaborator
Study Sites (1)
Bezmialem vakif university
Istanbul, Fatih, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeynep Buket Kaynar, Dr
Bezmialem Vakif University
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
- Principal Investigator
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 16, 2019
Study Start
September 9, 2017
Primary Completion
September 16, 2017
Study Completion
September 10, 2018
Last Updated
October 16, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 12 months