- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685967
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin
April 15, 2024 updated by: Dr. Fatma Dilşad Öz, Hacettepe University
The clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared.
After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician.
All caries lesions will be removed before restoring.
Cavities will be divided into two groups: a restorative glass ionomer [Equia Forte HT, GC, Tokyo, Japan (EHT)] and bulk-fill composite resin [SonicFill2, Orange, CA, USA (SBF)] 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age range will be 18 to 65
- patients should have at least 2 approximal caries lesions require restoration
- healthy periodontal status
- a good likelihood of recall availability
Exclusion Criteria:
- poor gingival health
- adverse medical history
- potential behavioral problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glass-ionomer
Equia Forte HT, GC, Tokyo, Japan (EHT)
|
Equia Forte HT, GC, Tokyo, Japan
|
Experimental: Bulk-Fill
SonicFill2, Orange, CA, USA (SBF)
|
SonicFill2, Orange, CA, USA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical performances of different restorative systems according to USPHS criteria
Time Frame: two years
|
Two year results according to USPHS criteria
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2021
Primary Completion (Actual)
August 15, 2021
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
December 22, 2020
First Submitted That Met QC Criteria
December 22, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- glass ionomer-bulk fill
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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