Impact of Genetic Polymorphisms on Dental Implant Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01274442
First received: January 10, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

Patients that may participate in this case-control study underwent dental implant surgery in the University Hospital in Ghent in 2004-2007.

According to one of our recent papers based on this patient group, 34/461 patients lost one or more implants. The goal is to invite these 34 patients, to update the anamnesis, to perform a brief clinical oral examination and to have a blood sample. The latter is necessary to identify relevant genetic polymorphisms of the patient that are associated with implant loss. Among the remaining patients that did not lose implants, another 34 'controls' will be invited for the same examinations.


Condition Intervention
Patients Treated by Means of 1 or More Dental Implants
Other: anamnesis
Procedure: oral examination
Procedure: Blood sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Case-control Study on the Impact of Genetic Polymorphisms on Dental Implant Loss.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • genetic polymorphisms associated with implant loss [ Time Frame: after 3 to 6 years ] [ Designated as safety issue: No ]
    Identification of genetic polymorphisms that are associated with implant loss. It concerns only one evaluation (1 blood sample).


Estimated Enrollment: 68
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CONTROL: no dental implants lost
Group of patients who received an implant during a dental implant surgery in the University Hospital in Ghent in 2004-2007, who did not lose their implants.
Other: anamnesis
To update the anamnesis.
Procedure: oral examination
A brief clinical oral examination will be performed.
Procedure: Blood sample
A blood sample will be taken to identify relevant genetic polymorphisms.
Experimental: CASE: patients lost one or more implants
Group of patients who received an implant during a dental implant surgery in the University Hospital in Ghent in 2004-2007, but who lost one or more implants.
Other: anamnesis
To update the anamnesis.
Procedure: oral examination
A brief clinical oral examination will be performed.
Procedure: Blood sample
A blood sample will be taken to identify relevant genetic polymorphisms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dental implant surgery in the University Hospital in Ghent in 2004-2007.
  • Case: dental implant loss
  • Control: no dental implant loss

Exclusion Criteria:

-

  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: NCT01274442

Contacts
Contact: Elisabeth De Wilde, Dentist Elisabeth.DeWilde@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Elisabeth De Wilde, Dentist       Elisabeth.DeWilde@ugent.be   
Principal Investigator: Hugo De Bruyn, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01274442     History of Changes
Other Study ID Numbers: 2010/771
Study First Received: January 10, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
dental implant

ClinicalTrials.gov processed this record on July 31, 2014