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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
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
February 10, 2020
Last Updated
August 21, 2023
Sponsor
Hacettepe University
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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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