E-max CAD Crowns Retained With Fiber Reinforced Composite Post Versus E-max CAD Endocrowns
One Year Clinical Evaluation of E-max CAD Crowns Retained With Fiber Reinforced Composite Post Versus E-max CAD Endocrowns in Anterior Endodontically Treated Teeth: A Randomized Clinical Trial
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
Different types of post and core have been used for several years for restoring anterior endodontically treated teeth, but their preparations involve various risks such as: root perforation, root weakness and tooth fracture. The introduction of adhesive systems and conservative restorations, make it possible to reconstruct damaged anterior endodontically treated teeth with conservative restoration as endocrowns. The hypothesis of this trial is that E-max CAD endocrowns will show comparably equal clinical performance if compared to E-max CAD crowns retained with fiber reinforced composite post and core system when treating anterior endodontically treated teeth..
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 Dec 2017
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
October 29, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedNovember 7, 2017
November 1, 2017
1.2 years
October 29, 2017
November 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gross Fracture
it indicates if the restoration is intact and fully retained or not using USPHS criteria for recording Categorical Alpha (A):Restoration is intact and fully retained.Bravo (B):Restoration is partially retained with some portion of the restoration still intact.Charlie (C):Restoration is completely missing
12 months
Secondary Outcomes (2)
Patient Satisfaction
12 months
Marginal Integrity
12 months
Study Arms (2)
E-max CAD crowns retained with Fiber Reinforced Composite Post
ACTIVE COMPARATORThe modulus of elasticity of FRC post is (18-22 GPa) resembling that of dentin. Ideally the remaining tooth, the fiber post and the composite cement create a "monoblock" in which the loads are uniformly dissipated, ensuring a behavior similar to healthy teeth with a lower risk of root fracture. Using lithium disilicate e.max restorations is documented in literature as a successful restoration.
E-max CAD Endocrowns
EXPERIMENTALEndocrowns have several advantages over conventional crowns like adequate function and esthetic with less chair time reduced number of interfaces in the restorative system. Stress concentration is less because of the reduction in the nonhomogenous material present. The preparation design is conservative compared to the traditional crown. Supragingival margin prevents interferences with periodontal tissues so involvement of the biological width is minimal. The application and polymerization of resins is also better controlled. Emax ceramic material have a high mechanical strength and are capable of being acid etched, with the adhesive capacity of adhesive systems and resinous cements, made it possible to restore endodontically treated teeth, without cores and intraradicular posts.
Interventions
endocrown used to restore endodontically treated teeth with E-max CAD endocrowns
fiber reinforced composite post need to restore endodontically treated tooth with E-max crown
Eligibility Criteria
You may qualify if:
- Age range of the patients from 20-60 years old who can read and sign informed consent document. Illiterate patients will be excluded.
- Patients willing to return for follow-up examinations and evaluation.
- Medically free patients or with controlled systemic disease.
- No active periodontal disease.
- Patients with anterior endodontically treated tooth/teeth indicated for Endocrown restoration (e.g. teeth without missing any wall, 2-3mm of sound tooth structure above cement-enamel junction).
You may not qualify if:
- Patients under 20 years old.
- Patients with bad oral hygiene and motivation.
- Patients with psychiatric problems or unrealistic expectation (patient have phobia from dental treatments or needle bricks).
- Patients with missing teeth opposing to the area intended for restoration.
- Patients with parafunctional habits (clencing /bruxism).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- no masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
October 29, 2017
First Posted
November 6, 2017
Study Start
December 1, 2017
Primary Completion
February 1, 2019
Study Completion
April 1, 2019
Last Updated
November 7, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share