NCT04798300

Brief Summary

The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

January 28, 2021

Last Update Submit

June 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations

    measured by Geomagic professional software

    one year

Secondary Outcomes (1)

  • Wear of restorations to tested opposed to natural teeth

    one year

Study Arms (2)

tested material

OTHER

Newly Introduced Gradient Monolithic Zirconia (Intervention)

Procedure: Newly Introduced Gradient Monolithic Zirconia

comparator material

ACTIVE COMPARATOR

Full Strength Monolithic Zirconia (Comparator)

Procedure: Full Strength Monolithic Zirconia

Interventions

Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear

tested material

Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear

comparator material

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects are required to be:
  • From 18-50 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 planned for a single coverage restoration in the posterior area.
  • Patients with a natural (not crowned) opposing antagonist.
  • Able to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Attrition

Condition Hierarchy (Ancestors)

Tooth WearTooth DiseasesStomatognathic Diseases

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
principle investigator

Study Record Dates

First Submitted

January 28, 2021

First Posted

March 15, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR