NCT03314545

Brief Summary

Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"

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
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

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 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

October 15, 2017

Last Update Submit

October 15, 2017

Conditions

Keywords

endocrownlaminate veneer with coronal postpost and corecrown

Outcome Measures

Primary Outcomes (1)

  • Gross Fracture

    : 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.

    one year

Secondary Outcomes (4)

  • marginal integrity

    one year

  • marginal discoloration

    one year

  • color match

    one year

  • caries

    one year

Study Arms (2)

laminate veneers with coronal posts

OTHER

anterior endodontically treated teeth restored with laminate veneers with coronal posts

Procedure: laminate veneer with coronal post

post, core and crown

OTHER

anterior endodontically treated teeth restored with post, core and crown

Procedure: post,core and crown

Interventions

laminate veneer with coronal post

Also known as: anterior endocrown, endolam, endolaminate
laminate veneers with coronal posts

post,core and crown

post, core and crown

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • From 18-60 years old, should be able to read and sign the consent document.
  • Ability to tolerate the restorative procedures (physical and psychological).
  • Patients with anterior endodontically treated teeth indicated for coronal restoration:
  • Good oral hygiene
  • Minimum remaining coronal tooth height of 4 mm
  • Normal functional occlusal stresses within physiological limits.
  • Adequate crown/root ratio
  • No signs and symptoms related to active periapical pathosis or endodontic failure.
  • With no active periodontal or pulpal problems.
  • Willing to return for follow-up visits.

You may not qualify if:

  • Teeth not fully erupted as in young patients.
  • Poor oral hygiene and lack of motivation
  • Vital teeth
  • Psychiatric problems or unrealistic expectations
  • Excessive parafunctional stresses and bad habits like nail biting. 11
  • The absence of sound enamel margins for the preparation
  • Abnormally small teeth or with structural defects in enamel. 12
  • Tooth mobility or inadequate crown/root ratio.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Crowns

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

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
Assistant Lecturer

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 19, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share