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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tooth Disease

Intervention / Treatment
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* Device: Fuji Bulk
* Device: G-ænial Posterior


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fuji Bulk<br>Glass ionomer (Fuji Bulk, GC, Tokyo Japan) | Device: Fuji Bulk<br>* Restorative system<br>|
| Experimental: G-ænial Posterior<br>Posterior composite resin(G-ænial Posterior, GC, Tokyo Japan) | Device: G-ænial Posterior<br>* Restorative system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different restoratiove systems | Two year results according to USPHS criteria | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-caries cervical lesions, glass ionomer, composite resin