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NCT04266210 Clinical Trial

Clinical Evaluation of a Restorative Glass Ionomer and a Composite Resin for the Restoration

Tooth Disease Clinical Trial

Official title:
Clinical Evaluation Two Restorative Systems in Non-carious Cervical Lesions at Patients With Different Systemic Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04266210
Other study ID # Glass ionomer - Composite
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2023

Study information
Verified date August 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The clinical performances of a restorative glass ionomer and a composite resin will be compared in the restoration of non-carious cervical lesions (NCCLs) at patients with systemic diseases. After recruiting participants with at least 2 NCCLs and at least one systemic disease, all restorations will be placed by a single clinician. All lesions will be cleaned before restoring. NCCLs will be divided into two groups: a conventional restorative glass ionomer cement [Fuji Bulk (GC, Tokyo Japan) (FB)] and a posterior composite resin [G-ænial Posterior (GC, Tokyo Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date December 1, 2023
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Patients with at least one systemic disease such as hypertension, cancer in remission after chemotherapy or radiotherapy, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus. Patients using medications for hypertension, diabetes mellitus, hemophilia, heart disease, coronary artery disease, rheumatoid arthritis, chronic obstructive pulmonary disease, lupus eritematozus. Patients who are able to attend recall appointments. Age greater than 18 years who had at least one systemic disease At least two NCCLs needed to be restored. At least 20 teeth in occlusion. Exclusion Criteria: Non-vital teeth Mobility of teeth Severe periodontal disease Heavy bruxism habit

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fuji Bulk
Restorative system
• G-ænial Posterior
Restorative system

Locations
Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performances of different restoratiove systems Two year results according to USPHS criteria two years
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