NCT03331887

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Status
unknown

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

October 29, 2017

Last Update Submit

November 5, 2017

Conditions

Keywords

endodontically treate teethEmax crownsFiber reinforced composite postEndocrowns

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 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.

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

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.

Procedure: E-max CAD endocrown

Interventions

endocrown used to restore endodontically treated teeth with E-max CAD endocrowns

E-max CAD Endocrowns

fiber reinforced composite post need to restore endodontically treated tooth with E-max crown

E-max CAD crowns retained with Fiber Reinforced Composite Post

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Central Study Contacts

Yasmin Hesham Abou El-Enein, Assistant lecturer

CONTACT

Amina abdEllatif Zaki, Professor

CONTACT

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