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

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.

Study Overview

• Status: Unknown
• Conditions: Bruxism; Noncarious Cervical Lesions
• Intervention / Treatment: Device: tooth restoration

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).

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: glass hybrids; bruxism; Non carious cervical lesions
• Additional Relevant MeSH Terms: Uterine Diseases; Stomatognathic Diseases; Tooth Diseases; Bruxism; Uterine Cervical Diseases
• Other Study ID Numbers: KA-16020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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