Clinical Performance of Bioactive Restorative Material Versus Glass Hybrid Restorative in Posterior Restorations
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Clinical performance of bioactive restorative material versus glass hybrid restorative in posterior restorations of high caries risk patients will be evaluated over 12 months using Fédération Dentaire Internationale' (FDI) 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 P25-P50 for not_applicable
Started Oct 2018
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
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 2, 2018
July 1, 2018
1.5 years
July 24, 2018
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
(FDI) criteria includes : * Biological properties (Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral \& general health) * Esthetic properties (Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form) * Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour \&wear (quantitatively \& qualitatively), Proximal anatomical form(contact point \&contour), Radiographic examination(when applicable) \&Patient's view) For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor). Subscales will not be combined
Change from the baseline at 6 months and12 months
Study Arms (2)
Resin-modified glass ionomer
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.
Bulk-fill glass hybrid restorative
ACTIVE COMPARATOREQUIA Forte is a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, 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.
It's a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating.
Eligibility Criteria
You may qualify if:
- High caries risk patients with multiple posterior cavitated carious lesions
- 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:
- Low caries risk patients.
- Anterior carious lesions
- Lack of compliance
- Severe medical complications.
- Pregnancy.
- Evidence of parafunctional habits
- Temporomandibular joint disorders
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (5)
Bansal R, Burgess J, Lawson NC. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent. 2016 Jun;29(3):171-4.
PMID: 27505995BACKGROUNDFleming GJ, Awan M, Cooper PR, Sloan AJ. The potential of a resin-composite to be cured to a 4mm depth. Dent Mater. 2008 Apr;24(4):522-9. doi: 10.1016/j.dental.2007.05.016. Epub 2007 Jul 31.
PMID: 17669481BACKGROUNDHickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PMID: 20628774BACKGROUNDHickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007 Mar;11(1):5-33. doi: 10.1007/s00784-006-0095-7. Epub 2007 Jan 30.
PMID: 17262225BACKGROUNDPameijer CH, Garcia-Godoy F, Morrow BR, Jefferies SR. Flexural strength and flexural fatigue properties of resin-modified glass ionomers. J Clin Dent. 2015;26(1):23-7.
PMID: 26054188BACKGROUND
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Mai M Yousry, PhD
Professor of Conservative Dentistry, Cairo University
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
- Principal Investigator and PHD student at Conservative Dentistry Department
Study Record Dates
First Submitted
July 24, 2018
First Posted
July 31, 2018
Study Start
October 1, 2018
Primary Completion
April 1, 2020
Study Completion
June 1, 2020
Last Updated
August 2, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share