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Clinical Trials/NCT04266210
NCT04266210
Completed
Not Applicable

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

Hacettepe University1 site in 1 country30 target enrollmentOctober 1, 2018
ConditionsTooth Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Disease
Sponsor
Hacettepe University
Enrollment
30
Locations
1
Primary Endpoint
Clinical performances of different restoratiove systems
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
December 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Fatma Dilşad Öz

Assistant Professor

Hacettepe University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical performances of different restoratiove systems

Time Frame: two years

Two year results according to USPHS criteria

Study Sites (1)

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