Back to resultsClinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism
Primary Purpose
Bruxism, Noncarious Cervical Lesions
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tooth restoration
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism focused on measuring glass hybrids, bruxism, Non carious cervical lesions
Eligibility Criteria
Inclusion Criteria:
- non-hospitalized, healthy patients that were seeking dental treatmen
- occlusally contacted teeth
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
"composite resin", "Ceram-x One Universal"
"glass ionomer cement", "Equia Forte"
Arm Description
tooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
Tooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
marginal adaptation score alpha
It represents the marginal integrity of the restorations. It is scored as alpha (perfect marginal adaptation), bravo (detectable marginal discrepency, clinically acceptable) or charlie (marginal crevice, clinically unacceptable). The examination of marginal adaptation is performed by clinical examination of the restoration with probe.
Full Information
NCT ID
NCT03713827
First Posted
October 15, 2018
Last Updated
October 18, 2018
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT03713827
Brief Title
Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism
Official Title
24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
May 2022 (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
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (NCCLs) of patients with bruxism.
For this purpose, twenty-five patients having NCCLs and bruxism enrolled to the present study. Before treatment, the dimensions of the NCCLs were measured in depth, gingival-incisal height and mesio-distal width using a CPI probe. Degree of tooth wear (TWI) and gingival conditions (GI) are also recorded. A total of 148 NCCLs were randomly restored with a a glass-hybrid-restorative system (Equia Forte Fil, GC, Tokyo, Japan) or a nano ceramic composite resin (Ceram.X One Universal, Dentsply, DeTrey, Konstanz, Germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-USPHS criteria. Data were analyzed with Chi- Square, Fisher's Exact Test, Mann Whitney-U and Cochran's Q tests (p < 0.05).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Noncarious Cervical Lesions
Keywords
glass hybrids, bruxism, Non carious cervical lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
double blinded, split mouth, randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"composite resin", "Ceram-x One Universal"
Arm Type
Active Comparator
Arm Description
tooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
Arm Title
"glass ionomer cement", "Equia Forte"
Arm Type
Active Comparator
Arm Description
Tooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"
Intervention Type
Device
Intervention Name(s)
tooth restoration
Intervention Description
restoration of non carious cervical lesions with two different restorative materials
Primary Outcome Measure Information:
Title
Retention Alpha for at least 90% of the restorations
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
marginal adaptation score alpha
Description
It represents the marginal integrity of the restorations. It is scored as alpha (perfect marginal adaptation), bravo (detectable marginal discrepency, clinically acceptable) or charlie (marginal crevice, clinically unacceptable). The examination of marginal adaptation is performed by clinical examination of the restoration with probe.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-hospitalized, healthy patients that were seeking dental treatmen
occlusally contacted teeth
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism
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