NCT00737308

Brief Summary

The objectives of this study are to determine the clinical performance of zirconia-based dental prostheses and their related properties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

6.8 years

First QC Date

August 17, 2008

Last Update Submit

May 14, 2015

Conditions

Dental Restoration Wear

Keywords

crownsceramics

Outcome Measures

Primary Outcomes (1)

  • ceramic crown fracture

    2 years

Secondary Outcomes (1)

  • masticatory function

    2 years

Study Arms (1)

A

EXPERIMENTAL

crown for clasp

Other: ceramic crown

Interventions

ceramic crownOTHER

Zirconia

Also known as: Zirconia
A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
  • Bruxism: No evidence based on an intraoral exam
  • Dental history: No evidence of either moderate or severe periodontal disease
  • Medical history: Good to excellent general health

You may not qualify if:

  • Periodontal status: Pocket depth greater than 4 mm
  • Occlusion: Evidence of bruxism or excessive clenching force, Abutment tooth that opposes a removable partial denture, Abutment teeth for fixed partial dentures, Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction, Tooth with first or second degree of tooth mobility, Tooth with extensive carious lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry, Mahidol University

Pyathai, Bangkok, 10400, Thailand

Location

Faculty of Dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

zirconium oxide

Study Officials

  • Kallaya Suputtamongkol

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2008

First Posted

August 19, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

TH(2)