Completed

NCT Number: NCT04266210

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

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.

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Key information

Conditions

Tooth Disease Stomatognathic Diseases Tooth Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fuji Bulk

Device

Restorative system

G-ænial Posterior

Device

Restorative system

Primary outcomes

Clinical performances of different restoratiove systems

Time frame: two years

Two year results according to USPHS criteria

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2023
First posted: Feb 12, 2020
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed