Wear of Enamel Against Polished Zirconia Crowns

NCT02289781 | Completed

• 2 other identifiers: IRB20120000200104254
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic crowns. This single-blind pilot study will involve a total of 30 teeth that require full coverage crowns that oppose natural antagonist teeth. The objectives of this research are to test the following hypotheses: (1) differences between mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished veneer surface of metal-ceramic crowns are statistically significant; (2) differences between mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by opposing enamel are statistically significant; and (3) differences between mean antagonist wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by opposing enamel are statistically significant.

Conditions

Tooth Wear

Outcome Measures

Primary Outcomes (1)

• Change from baseline, 1 year, 2 years, and 3 years wear of Enamel Antagonist

  The wear of the enamel opposing the monolithic zirconia will be measured and compared with wear with the metal-ceramic crowns by using scanning technology to scan the teeth at baseline and then at the succeeding time periods. Also, impressions of the teeth will be used on a laser scanner to measure the volume loss on the crowns and the opposing teeth.

  Change from baseline, 1 year, 2 years, and 3 years

Secondary Outcomes (1)

• Change from baseline, 1 year, 2 years, and 3 years in the wear of Zirconia and Metal-Ceramic Crowns

  Change from baseline, 1 year, 2 years, and 3 years

Study Arms (2)

Zirconia posterior crowns

Monolithic zirconia crowns which are polished and non-glazed

Device: posterior crowns

Metal-Ceramic posterior crowns

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

Device: posterior crowns

Interventions

posterior crowns DEVICE

teeth will be prepared to receive posterior crown made of either zirconia or metal-ceramic material

Metal-Ceramic posterior crowns; Zirconia posterior crowns

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients accessing care in a dental clinc needing full coverage crowns.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• 3M Pharmaceuticals Pty Limited: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• F Esquivel-Upshaw J, Hsu SM, Bohorquez AC, Abdulhameed N, Scheiffele GW, Kim M, Neal D, Chai J, Ren F. Novel methodology for measuring intraoral wear in enamel and dental restorative materials. Clin Exp Dent Res. 2020 Dec;6(6):677-685. doi: 10.1002/cre2.322. Epub 2020 Sep 21.

  PMID: 32955159 DERIVED

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Josephine F. Esquivel-Upshaw, D.M.D., M.S.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 13, 2014
• Study Start: April 1, 2013
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)