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

Hacettepe University

Status: Unknown

Conditions: Bruxism; Noncarious Cervical Lesions

Treatments: Device: tooth restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT03713827

KA-16020

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 42 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

"composite resin", "Ceram-x One Universal"

Active Comparator group

Description:

tooth restoration with nano-ceramic composite resin "Ceram-x one Universal"

Treatment:

Device: tooth restoration

"glass ionomer cement", "Equia Forte"

Active Comparator group

Description:

Tooth restoration with glass ionomer cement (Glass hybrid restorative system) "Equia Forte"

Treatment:

Device: tooth restoration