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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03713827
Recruitment Status : Active, not recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Information provided by (Responsible Party):
Ece Meral, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Bruxism Noncarious Cervical Lesions Device: tooth restoration Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: double blinded, split mouth, randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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

Primary Outcome Measures :
  1. Retention Alpha for at least 90% of the restorations [ Time Frame: 24 months ]
    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.

Secondary Outcome Measures :
  1. marginal adaptation score alpha [ Time Frame: 24 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
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Responsible Party: Ece Meral, principal investigator, Hacettepe University Identifier: NCT03713827    
Other Study ID Numbers: KA-16020
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Ece Meral, Hacettepe University:
glass hybrids
Non carious cervical lesions
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Tooth Diseases
Stomatognathic Diseases
Uterine Diseases
Genital Diseases, Female