Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control Trial
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer (RMGI) in class V o will be evaluated over 12 months using United State Public Health Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations
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 Mar 2019
Longer than P75 for not_applicable
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
December 7, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedDecember 11, 2018
December 1, 2018
3.4 years
December 7, 2018
December 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the clinical performance using United State Public Health Service (USHPS)
Change from the baseline at 6 months and12 months
Study Arms (2)
Bioactive-Restorative material
EXPERIMENTALActiva Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.
Resin Modified Glass Ionomer (RMGI)
ACTIVE COMPARATORFuji II Lc, fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics a wear-resistant, self-adhesive, light-cured resin coating.
Interventions
enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth
Enhanced glass ionomer with acceptable mechanical properties and esthtic properties
Eligibility Criteria
You may qualify if:
- Cervical Class V carious lesions.
- Age 18-50 years.
- Co-operative patients approving to participate in the study.
- Pulp asymptomatic vital carious posterior teeth.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
You may not qualify if:
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylates
- Rampant caries
- Pregnancy
- Disabilities
- Heavy smoking; xerostomia
- Lack of compliance
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
o ALKHUDHAIRY FI & ZH, A. 2016. Comparison of Shear Bond Strength and Microleakage of Various Bulk-fill Bioactive Dentin substitutes: An in vitro study. J Contemp Dent Pract, 17. o B. RANJBAR OMIDI, F. F. N., H. DEHGHAN, P. TAMIZ, M. MOHAMMADI SAVADROODBARI, AND R. JABBARIAN, 2018. Microleakage of an Enhanced Resin-Modified Glass Ionomer Restorative Material in Primary Molars. Journal of Dentistry of Tehran University of Medical Sciences (jdt), 15. o BANSAL, R., BURGESS, J. & LAWSON, N. C. 2016. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent, 29, 171-4. o CROLL, T. P., BERG, J. H. & DONLY, K. J. 2015. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent, 36, 60-5. o GAROUSHI, S., VALLITTU, P. K. & LASSILA, L. 2018. Characterization of fluoride releasing restorative dental materials. Dent Mater J, 37, 293-300. o HICKEL, R., PESCHKE, A., TYAS, M., MJOR, I., BAYNE, S., PETERS, M., HILLER, K. A., RANDALL, R., VANHERLE, G. & HEINTZE, S. D. 2010. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent, 12, 259-72. o MICHOU, S., LARSEN, L., BENETTI, A. R. & PEUTZFELDT, A. 2018. Adhesion and marginal integrity of bioactive restorative materials. Dental Materials, 34, e11. o NAGI, S. M., MOHARAM, L. M. & EL HOSHY, A. Z. 2018. Fluoride release and recharge of enhanced resin modified glass ionomer at different time intervals. Future Dental Journal. o NEMATOLLAHI, H., BAGHERIAN, A., GHAZVINI, K., ESMAILY, H. & MEHR, M. A. 2017. Microbial microleakage assessment of class V cavities restored with different materials and techniques: A laboratory study. Dental research journal, 14, 344-350. o OWENS, B. M., PHEBUS, J. G. & JOHNSON, W. W. 2018. Evaluation of the marginal integrity of a bioactive restorative material. Gen Dent, 66, 32-36. o PAMEIJER, C. H., GARCIA-GODOY, F., MORROW, B. R. & JEFFERIES, S. R. 2015. Flexural strength and flexural_fatigue. J Clin Dent, 26, 5. o PERDIGAO, J., DUTRA-CORREA, M., SARACENI, S. H., CIARAMICOLI, M. T. & KIYAN, V. H. 2012. Randomized clinical trial of two resin-modified glass ionomer materials: 1-year results. Oper Dent, 37, 591-601.2016. Guideline on Restorative Dentistry. Pediatr Dent, 38, 250-262.
BACKGROUND
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Yehia Hafez Yehia
Study Record Dates
First Submitted
December 7, 2018
First Posted
December 11, 2018
Study Start
March 1, 2019
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
December 11, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL