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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02289781




Registration number
NCT02289781
Ethics application status
Date submitted
7/11/2014
Date registered
13/11/2014

Titles & IDs
Public title
Wear of Enamel Against Polished Zirconia Crowns
Scientific title
Wear of Enamel Antagonists by Polished Ceramic Surfaces
Secondary ID [1] 0 0
00104254
Secondary ID [2] 0 0
IRB201200002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth Wear 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - posterior crowns

Zirconia posterior crowns - Monolithic zirconia crowns which are polished and non-glazed

Metal-Ceramic posterior crowns - Metal-supported glass-ceramic veneered crowns which are polished and non-glazed


Treatment: Devices: posterior crowns
teeth will be prepared to receive posterior crown made of either zirconia or metal-ceramic material
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline, 1 year, 2 years, and 3 years wear of Enamel Antagonist
Timepoint [1] 0 0
Change from baseline, 1 year, 2 years, and 3 years
Secondary outcome [1] 0 0
Change from baseline, 1 year, 2 years, and 3 years in the wear of Zirconia and Metal-Ceramic Crowns
Timepoint [1] 0 0
Change from baseline, 1 year, 2 years, and 3 years

Eligibility
Key inclusion criteria
* Subjects must be over 21 years of age and in good overall health. No contraindications to dental treatment are present
* Subjects must be in good overall good dental health and are at a low caries risk, with no active tooth decay (caries), and no periodontal disease. Periodontal pocket depths on all remaining teeth are not greater than 4 mm
* Subjects must have no existing temporomandibular disorder, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. bruxism, clenching)
* Subjects must need a crown on either a first or second premolar or first or second molar in any arch. Abutment teeth must be restorable and have a crown:root ratio of at least 1:1. Abutment teeth must have a full complement of opposing non-restored or minimally restored natural teeth. Minimally restored means the teeth contain no restoration greater than a Class II amalgam restoration. The opposing arch must not have a full coverage restoration or a partial denture. The contralateral tooth and its antagonist are present
* Subjects must exhibit good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
* Subjects must exhibit a normal flow of saliva. Subjects with any medical pathologies that limit salivary flow volume or who require a chronic intake of medications that minimize flow of saliva will be excluded from the study
* Subjects must be willing to pay $500 for the clinic incidentals and they must be compliant with yearly appointments
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* anything that does not meet inclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2022
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
University of Florida
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
3M Pharmaceuticals Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Josephine F. Esquivel-Upshaw, D.M.D., M.S.
Address 0 0
University of Florida
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02289781