- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04266210
Clinical Evaluation of a Restorative Glass Ionomer and a Composite Resin for the Restoration
Clinical Evaluation Two Restorative Systems in Non-carious Cervical Lesions at Patients With Different Systemic Diseases
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fuji Bulk
Glass ionomer (Fuji Bulk, GC, Tokyo Japan)
|
Restorative system
|
Experimental: G-ænial Posterior
Posterior composite resin(G-ænial Posterior, GC, Tokyo Japan)
|
Restorative system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical performances of different restoratiove systems
Time Frame: two years
|
Two year results according to USPHS criteria
|
two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Glass ionomer - Composite
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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