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

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ACTIVA bioactive
Riva LC
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ACTIVA bioactive

Riva LC

Arm Description

bioactive ionic resin composite

Resin-modifed glass ionomer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2022
Last Updated
July 20, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05470959
Brief Title
Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
Acronym
BIRCRMGILYCT
Official Title
Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIVA bioactive
Arm Type
Other
Arm Description
bioactive ionic resin composite
Arm Title
Riva LC
Arm Type
Other
Arm Description
Resin-modifed glass ionomer
Intervention Type
Other
Intervention Name(s)
ACTIVA bioactive
Intervention Description
bioactive ionic resin composite
Intervention Type
Other
Intervention Name(s)
Riva LC
Other Intervention Name(s)
Riva light cure
Intervention Description
resin-modified glass ionomer
Primary Outcome Measure Information:
Title
assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria
Description
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.
Time Frame
2-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
salah mahmoud, professor
Organizational Affiliation
faculty of dentistry, mansoura university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Mansoura
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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