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Completed

NCT Number: NCT05470959

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

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

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTIVA bioactive

Other

bioactive ionic resin composite

Riva LC

Other

resin-modified glass ionomer

Other names: Riva light cure

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: BIRCRMGILYCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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