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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 10, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 10, 2025
March 1, 2025
2 months
February 10, 2020
March 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical performances of different restoratiove systems
Two year results according to USPHS criteria
two years
Study Arms (2)
Fuji Bulk
EXPERIMENTALGlass ionomer (Fuji Bulk, GC, Tokyo Japan)
G-ænial Posterior
EXPERIMENTALPosterior composite resin(G-ænial Posterior, GC, Tokyo Japan)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Non-vital teeth
- Mobility of teeth
- Severe periodontal disease
- Heavy bruxism habit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 10, 2020
First Posted
February 12, 2020
Study Start
October 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2023
Last Updated
March 10, 2025
Record last verified: 2025-03