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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05470959
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
26.3
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: ACTIVA bioactive
  • Other: Riva LC
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
Actual Study Start Date :
Oct 10, 2019
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Dec 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: ACTIVA bioactive

bioactive ionic resin composite

Other: ACTIVA bioactive
bioactive ionic resin composite
Other: Riva LC

Resin-modifed glass ionomer

Other: Riva LC
resin-modified glass ionomer
Other Names:
  • Riva light cure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria [2-years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Mansoura Egypt 35111

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Study Director: salah mahmoud, professor, faculty of dentistry, mansoura university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05470959
    Other Study ID Numbers:
    • M19091019
    First Posted:
    Jul 22, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Jul 22, 2022