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NCT05470959 Clinical Trial

Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial

Dental Caries Clinical Trial

— BIRCRMGILYCT  

Official title:
Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05470959
Other study ID # M19091019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2019
Est. completion date December 20, 2021

Study information
Verified date July 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

Description:

patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 20, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6) - vital teeth - no sensitivity to teeth percussion - no spontaneous pain - no radiolucency in the periapical or furcation area of teeth - complete and normal occlusion - good oral hygiene Exclusion Criteria: - poor oral hygiene - severe or chronic periodontal problems - periapical lesions - heavy bruxism - non-vital teeth - visibly cracked teeth - spontaneous dental pain - sensitivity to teeth percussion

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ACTIVA bioactive
bioactive ionic resin composite
• Riva LC
resin-modified glass ionomer

Locations
Country Name City State
Egypt Faculty of Dentistry Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria comparison of 2-year clinical performance of recent bioactive ionic resin composite( ACTIVA bioactive) to resin-modified glass ionomer liner ( Riva LC) in indirect dental pulp treatment using FDI world dental federation clinical criteria. 2-years
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