Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
BIRCRMGILYCT
Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2021
CompletedFirst Submitted
Initial submission to the registry
July 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedJuly 22, 2022
July 1, 2022
2.1 years
July 19, 2022
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
ACTIVA bioactive
OTHERbioactive ionic resin composite
Riva LC
OTHERResin-modifed glass ionomer
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Al Mansurah, 35111, Egypt
Related Publications (1)
Ahmed B, Wafaie RA, Hamama HH, Mahmoud SH. 3-year randomized clinical trial to evaluate the performance of posterior composite restorations lined with ion-releasing materials. Sci Rep. 2024 Feb 28;14(1):4942. doi: 10.1038/s41598-024-55329-6.
PMID: 38418863DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
salah mahmoud, professor
faculty of dentistry, mansoura university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2022
First Posted
July 22, 2022
Study Start
October 10, 2019
Primary Completion
October 30, 2021
Study Completion
December 20, 2021
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share