An interventional study of tooth restoration in Bruxism and Noncarious Cervical Lesions, sponsored by Hacettepe University. Status unknown. Open to participants aged 42 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-22.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
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).
166 studies on the registry are indexed under Bruxism; 38 are open to participants now.
This study's enrollment of 25 is below the median of 38 across 103 interventional studies indexed under Bruxism.
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Exclusion Criteria:
tooth restoration with nano-ceramic composite resin "Ceram-x one Universal"
Device: tooth restoration
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
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.
Time frame: 24 months
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.
Time frame: 24 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Hacettepe University