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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713827
Enrollment
25
Registered
2018-10-22
Start date
2016-03-31
Completion date
2022-05-31
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Noncarious Cervical Lesions

Keywords

glass hybrids, bruxism, Non carious cervical lesions

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).

Interventions

restoration of non carious cervical lesions with two different restorative materials

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

double blinded, split mouth, randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
42 Years to 72 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Retention Alpha for at least 90% of the restorations24 monthsThe 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

MeasureTime frameDescription
marginal adaptation score alpha24 monthsIt 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026