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

Not Applicable

Completed

• Conditions: Tooth Disease
• Interventions: Device: Fuji Bulk; Device: G-ænial Posterior

• Registration Number: NCT04266210
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2018-12-01
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Completion: 2023-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuji Bulk	Fuji Bulk	Glass ionomer (Fuji Bulk, GC, Tokyo Japan)
G-ænial Posterior	G-ænial Posterior	Posterior composite resin(G-ænial Posterior, GC, Tokyo Japan)

Primary Outcome Measures

Name	Time	Method
Clinical performances of different restoratiove systems	two years	Two year results according to USPHS criteria

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey