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Clinical Trials/NCT03331887
NCT03331887UnknownNot Applicable

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

Cairo University0 sites32 target enrollmentStarted: December 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
32
Primary Endpoint
Gross Fracture

Study Overview

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..

Detailed Description

This trial will be conducted on patients from the out patient clinic in the fixed prosthodontics clinic, Faculty of Oral and Dental Medicine, Cairo University.

  • Adherence session will take place in the presence of the patients in the initial visit. This include that the patients will be informed by Abou El-Enein Y about the study steps and maintenance of oral hygiene instructions. Participant will be asked by Abou El-Enein Y if they have any problem like pain.
  • Motivation and enforcing the maintenance of oral hygiene measures by Abou El-Enein Y.

The visits will be designed as follow:

  • st visit: (Y.A) will call participants before tooth preparation procedure for preoperative records, face to face adherence reminder session, clinical examination, radiograohic examination, pre-operative photographing, Impression taking for study cast analysis and waxing up. Each participant will be asked to sign consent form written in patient native language.

2nd visit: Tooth preparation for either e-max crown retained with fiber reinforced composie post or e-max endocrown, secondary impression and temporarization.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

no masking

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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).

Arms & Interventions

E-max CAD crowns retained with Fiber Reinforced Composite Post

Active Comparator

The 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.

Intervention: E-max CAd crowns retained with fiber reinforced composite post (Procedure)

E-max CAD Endocrowns

Experimental

Endocrowns 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.

Intervention: E-max CAD endocrown (Procedure)

Outcomes

Primary Outcomes

Gross Fracture

Time Frame: 12 months

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

Secondary Outcomes

  • Patient Satisfaction(12 months)
  • Marginal Integrity(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasmin Hesham Abou El-Enein

assistant lecturer

Cairo University

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