NCT03713827

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 42 Years – 72 Years
• Healthy volunteers: Accepted

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).

Conditions

• Bruxism
• Noncarious Cervical Lesions

Interventions

Type	Name	Description
DEVICE	tooth restoration	restoration of non carious cervical lesions with two different restorative materials

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-06-01
• Completion: 2022-05-01
• First posted: 2018-10-22
• Last updated: 2018-10-22

Regulatory

• FDA-regulated device study