Clinical Performance of Fiber Reinforced Composite Versus Microhybrid Composite Restorations
Clinical Performance of Direct Fiber Reinforced Resin Composite Restorations Versus Direct Microhybrid Resin Composite Restorations in Endodontically Treated Molars: A Randomized Clinical Trial
1 other identifier
interventional
56
1 country
1
Brief Summary
Clinical performance of direct fiber reinforced resin composite restorations versus direct microhybrid resin composite restorations in endodontically treated molars will be evaluated over 12 months using modified USPHS criteria.
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 Jan 2019
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
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedJanuary 27, 2021
January 1, 2021
1.1 years
April 20, 2018
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Clinical performance
Measured using modified USPHS criteria for clinical evaluation of restoration failure.
Change from the baseline at six months.
Study Arms (2)
Fiber resin composite
EXPERIMENTALFiber reinforced resin composite restoration used as dentin substitute covered by conventional resin composite
Microhybrid resin composite
ACTIVE COMPARATORMicrohybrid resin composite restoration with lower strength compared to Fiber reinforced resin composite restoration
Interventions
a type of resin composite with improved strength due to the fiber's action
a type of conventional resin composite
Eligibility Criteria
You may qualify if:
- Patients with Good oral hygiene.
- Co-operative patients approving to participate in the study.
- Endodontically treated molar with minimum to moderate loss of tooth structure.
- Presence of antagonists
You may not qualify if:
- Patients with advanced periodontal disease.
- Patients with parafunctional habits.
- Patients with temporomandibular joint disorders.
- Teeth with failed endodontic therapy or extensive caries.
- Pregnant female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry
Giza, Egypt
Related Publications (1)
Abouelleil H, Pradelle N, Villat C, Attik N, Colon P, Grosgogeat B. Comparison of mechanical properties of a new fiber reinforced composite and bulk filling composites. Restor Dent Endod. 2015 Nov;40(4):262-70. doi: 10.5395/rde.2015.40.4.262. Epub 2015 Sep 2.
PMID: 26587411BACKGROUND
Related Links
Study Officials
- STUDY DIRECTOR
Mohamed Farid, PHD
Professor of Conservative Dentistry, Cairo University
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
- Assistant lecturer at Conservative Dentistry Department
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 3, 2018
Study Start
January 1, 2019
Primary Completion
February 5, 2020
Study Completion
March 10, 2020
Last Updated
January 27, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share