NCT00889239

Brief Summary

The objectives of this study are to characterize the clinical performance and wear mechanisms of all-ceramic posterior crowns. The wear rate of all-ceramic crowns and opposing enamel in selected patients will be quantified. The relationship of each subject's maximum clenching force and wear rate will also be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
5.9 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

10.9 years

First QC Date

April 25, 2009

Last Update Submit

May 14, 2015

Conditions

Ceramic and Dental Enamel Wear

Keywords

ceramicwear rateopposing enamel

Outcome Measures

Primary Outcomes (1)

  • Clinical performance

    5 years

Secondary Outcomes (1)

  • wear rate

    2 years

Study Arms (1)

A

EXPERIMENTAL

ceramic crown

Other: lithia-disilicate-based crown

Interventions

lithia-disilicate-based crownOTHER

all-ceramic crown

Also known as: ceramic crown
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 examination
  • 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 biting or clenching force
  • Abutment tooth that opposes a removable partial denture
  • Abutment tooth 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 (1)

Faculty of Dentistry, Mahidol University

Bangkok, 10400, Thailand

Location

Study Officials

  • Kallaya Suputtamongkol

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 25, 2009

First Posted

April 28, 2009

Study Start

May 1, 2004

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

TH(1)