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

NCT ID: NCT04266210

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fuji Bulk

Glass ionomer (Fuji Bulk, GC, Tokyo Japan)

Group Type EXPERIMENTAL

Fuji Bulk

Intervention Type DEVICE

Restorative system

G-ænial Posterior

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

Group Type EXPERIMENTAL

G-ænial Posterior

Intervention Type DEVICE

Restorative system

Interventions

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Fuji Bulk

Restorative system

Intervention Type DEVICE

G-ænial Posterior

Restorative system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fatma Dilşad Öz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Glass ionomer - Composite

Identifier Type: -

Identifier Source: org_study_id

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