New Bioactive Restorative Material vs GIC in Restoration of Proximal Lesions
Bioactive
Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.
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 Nov 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedSeptember 22, 2020
September 1, 2020
10 months
April 20, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Proximal Contact (modified USPHS criteria)
Ordinal(Alfa/Bravo/Charlie)
6 months
Proximal Contact (modified USPHS criteria)
Ordinal(Alfa/Bravo/Charlie)
1 Year
Secondary Outcomes (2)
Retention(modified USPHS criteria)
6 Months
Retention(modified USPHS criteria)
1 Year
Study Arms (2)
New Bioactive Restorative Material
EXPERIMENTALACTIVA Presto restorative material
High Viscosity Glass Hybrid Reinforced Glass Ionomer
ACTIVE COMPARATOREQUIA Forte restorative material
Interventions
New Bioactive Restorative Material
High Viscosity Glass Hybrid Reinforced Glass Ionomer
Eligibility Criteria
You may qualify if:
- Proximal lesions in posterior premolars and molars and Age 20-40 years
You may not qualify if:
- Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rana Ayman Kamallead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 28, 2020
Study Start
November 1, 2020
Primary Completion
September 1, 2021
Study Completion
May 1, 2022
Last Updated
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share