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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tooth Disease
• Tooth Diseases

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