NCT04738513

Brief Summary

The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 31, 2021

Last Update Submit

February 3, 2021

Conditions

Single Anterior CrownsBadly Decayed TeethEndodontically Treated TeethSpacing Between Anterior TeethMalposed Teeth(Tilted,Overerupted,Totated,Etc.)

Outcome Measures

Primary Outcomes (1)

  • Marginal integrity

    Measured by using Modified United States Public Health Service criteria (USPHS criteria) * Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer) * Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer) * Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)

    1 year

Secondary Outcomes (5)

  • Gingival discoloration

    1 year

  • Gingival inflammation

    1 year

  • Restoration color stability

    1 year

  • Secondary caries

    1 year

  • patient satisfaction

    1 year

Study Arms (2)

Conventional preparation technique

ACTIVE COMPARATOR

Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.

Procedure: Conventional Preparation technique

Vertical preprartion

EXPERIMENTAL

Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique.

Procedure: Vertical preparation technique

Interventions

Vertical preparation techniquePROCEDURE

Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.

Also known as: Vertiprep
Vertical preprartion
Conventional Preparation techniquePROCEDURE

Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.

Conventional preparation technique

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • From 21-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Psychologically and physically able to withstand conventional dental procedures.
  • Patients with teeth problems indicated for all ceramic crowns in esthetic zone;
  • Badly decayed teeth
  • Teeth restored with large filling restorations
  • Endodontically treated teeth
  • Malformed teeth
  • Malposed teeth (Tilted, over-erupted, rotated, etc.)
  • Able to return for follow-up examinations and evaluation.
  • Thick gingival biotype.

You may not qualify if:

  • Patient less than 21or more than 50 years.
  • Patient with active resistant periodontal diseases.
  • Patients with poor oral hygiene and uncooperative patients.
  • Pregnant women.
  • Patients in the growth stage with partially erupted teeth.
  • Psychiatric problems or unrealistic expectations.
  • Patient with periodontal problems.
  • Patients with malocclusion or parafunctional habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Central Study Contacts

Menna ElGendy, MSD

CONTACT

00201093302027mennaelgendy@dentisrty.cu.edu.eg

Rana Sherif, Professor

CONTACT

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
Principal investigator

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations

EG(1)