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NCT04685967 Clinical Trial

Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

Tooth Disease Clinical Trial

Official title:
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04685967
Other study ID # glass ionomer-bulk fill
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 15, 2021
Est. completion date May 1, 2025

Study information
Verified date April 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 23
Est. completion date May 1, 2025
Est. primary completion date August 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Glass ionomer
Equia Forte HT, GC, Tokyo, Japan
• Bulk-fill composite
SonicFill2, Orange, CA, USA

Locations
Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)
Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical performances of different restorative systems according to USPHS criteria Two year results according to USPHS criteria two years
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