Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism
24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. The lesions were restored with glass hybrid restorative (Equia Forte) or nano ceramic composite resin (Ceram-x One). Restorations were evaluated after 24 months according to USPHS criteria and the data were evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
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
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedOctober 22, 2018
October 1, 2018
2.3 years
October 15, 2018
October 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention Alpha for at least 90% of the restorations
The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
24 months
Secondary Outcomes (1)
marginal adaptation score alpha
24 months
Study Arms (2)
"composite resin", "Ceram-x One Universal"
ACTIVE COMPARATORtooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
"glass ionomer cement", "Equia Forte"
ACTIVE COMPARATORTooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"
Interventions
restoration of non carious cervical lesions with two different restorative materials
Eligibility Criteria
You may qualify if:
- non-hospitalized, healthy patients that were seeking dental treatmen
- occlusally contacted teeth
You may not qualify if:
- Patients having intensive medical history
- Chronic periodontitis,
- high caries activity,
- extremely poor oral hygiene,
- teeth with restorations,
- mobility due to periodontal disease
- in contacted with removable prosthetic construction were excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 22, 2018
Study Start
March 1, 2016
Primary Completion
June 1, 2018
Study Completion
May 1, 2022
Last Updated
October 22, 2018
Record last verified: 2018-10