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

Primary Purpose

Tooth Disease

Status

Active

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Fuji Bulk

G-ænial Posterior

About this trial

This is an interventional treatment trial for Tooth Disease focused on measuring non-caries cervical lesions, glass ionomer, composite resin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fuji Bulk

G-ænial Posterior

Arm Description

Glass ionomer (Fuji Bulk, GC, Tokyo Japan)

Posterior composite resin(G-ænial Posterior, GC, Tokyo Japan)

Outcomes

Primary Outcome Measures

Clinical performances of different restoratiove systems

Two year results according to USPHS criteria

Secondary Outcome Measures

Full Information

NCT ID

NCT04266210

First Posted

February 10, 2020

Last Updated

August 21, 2023

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT04266210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Disease

Keywords

non-caries cervical lesions, glass ionomer, composite resin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fuji Bulk

Arm Type

Experimental

Arm Description

Glass ionomer (Fuji Bulk, GC, Tokyo Japan)

Arm Title

G-ænial Posterior

Arm Type

Experimental

Arm Description

Posterior composite resin(G-ænial Posterior, GC, Tokyo Japan)

Intervention Type

Device

Intervention Name(s)

Fuji Bulk

Intervention Description

Restorative system

Intervention Type

Device

Intervention Name(s)

G-ænial Posterior

Intervention Description

Restorative system

Primary Outcome Measure Information:

Title

Clinical performances of different restoratiove systems

Description

Two year results according to USPHS criteria

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Hacettepe University

City

Ankara

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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