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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04266210
Enrollment
30
Registered
2020-02-12
Start date
2018-10-01
Completion date
2023-12-01
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Disease

Keywords

non-caries cervical lesions, glass ionomer, composite resin

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.

Interventions

DEVICEFuji Bulk

Restorative system

Restorative system

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical performances of different restoratiove systemstwo yearsTwo year results according to USPHS criteria

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026