Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism

Study Overview
=================
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).

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

Conditions
-----------------
Bruxism, Noncarious Cervical Lesions

Intervention / Treatment
-----------------
* Device: tooth restoration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 72 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: double blinded, split mouth, randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: composite resin, Ceram-x One Universal<br>tooth restoration with nano-ceramic composite resin Ceram-x one Universal | Device: tooth restoration<br>* restoration of non carious cervical lesions with two different restorative materials<br>|
| Active Comparator: glass ionomer cement, Equia Forte<br>Tooth restoration with glass ionomer cement (Glass hybrid restorative system) Equia Forte | Device: tooth restoration<br>* restoration of non carious cervical lesions with two different restorative materials<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glass hybrids, bruxism, Non carious cervical lesions