NCT04805281

Brief Summary

In-vitro studies do not represent the actual masticatory environment and cannot simulate the intricate chewing pattern. Hence, there is a need for an in vivo study evaluating the wear potential of the newly introduced strength - color gradient multilayered zirconia IPS e.max ZirCAD Prime (5Y-TZP/3Y-TZP) and compare it to Lithium Disilicate IPS e.max CAD which has proven to have favorable wear patterns.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

February 17, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

February 17, 2021

Last Update Submit

June 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The amount of occlusal wear in natural antagonist enamel caused by the restorative material

    The amount of occlusal wear in natural antagonist enamel, using digital superimposition of model scans after 1 year, measured in micrometer.

    1 year

Secondary Outcomes (1)

  • The amount of occlusal wear in the restorative material itself

    1 year

Study Arms (2)

Lithium Disilicate IPS e.max crowns in posterior teeth

ACTIVE COMPARATOR
Other: Lithium Dislicate IPS e.max crown

Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth

EXPERIMENTAL
Other: monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.

Interventions

wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth

Monolithic Zirconia (5Y-TZP/3-YTZP) crowns in posterior teeth

wear of lithium disilicate IPS e.max crown in posterior teeth

Lithium Disilicate IPS e.max crowns in posterior teeth

Eligibility Criteria

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

You may qualify if:

  • All subjects are required to:
  • Be aged 21-50 years old, be able to read and sign the informed consent document. 2- Psychologically and physically able to withstand conventional dental procedures.
  • Patients with mutilated posterior teeth indicated for full coverage restorations.
  • Patients with sound natural antagonists. 5- Able to attend punctually for preplanned visits and evaluation. 6- Have no active periodontal or pulpal diseases.
  • There should be no apparent loss or wear in opposing enamel.

You may not qualify if:

  • Patient with active resistant periodontal diseases.
  • Patients with parafunctional habits and bruxism.
  • Patients with poor oral hygiene, high caries risk and uncooperative patients. 3- Pregnant women.
  • Patients in the growth stage with partially erupted teeth. 5- Psychiatric problems or unrealistic expectations.
  • Lack of opposing dentition in the area of interest. 7- Restored occlusal surface opposing the planned restoration. 8- The presence of a removable or fixed orthodontic appliance.

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

Rana Sherif, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 17, 2021

First Posted

March 18, 2021

Study Start

August 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations