Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluation of Implants Placed in the Regular Dentist's Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00286533
First received: February 1, 2006
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

This study is an evaluation of the implants placed in a regular dentist's practice regarding:

  • gingiva condition
  • stability of implant
  • prothetic quality
  • questionnaires for the patients

Condition Intervention
Dental Implant
Procedure: Clinical examination (implant stability, gingiva condition, etc.)
Procedure: Questionnaires

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retrospective Evaluation of Implants Placed in the Regular Dentist's Practice. A Study to Evaluate Implant Success, Prosthetic Complications, Opinion of the Patient, and Quality of Care

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • gingiva condition [ Time Frame: t0 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • stability of implant [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • prothetic quality [ Time Frame: t0 ] [ Designated as safety issue: No ]
  • questionnaires for the patients [ Time Frame: t0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placed implants Procedure: Clinical examination (implant stability, gingiva condition, etc.)
Clinical examination (implant stability, gingiva condition, etc.) to follow
Procedure: Questionnaires
Questionnaires are used.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with implants placed in a regular dentist's practice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286533

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00286533     History of Changes
Other Study ID Numbers: 2005/414 
Study First Received: February 1, 2006
Last Updated: December 4, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Implant

ClinicalTrials.gov processed this record on December 02, 2016