NCT01274442

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration 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

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2013

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

January 10, 2011

Last Update Submit

December 28, 2022

Conditions

Patients Treated by Means of 1 or More Dental Implants

Keywords

dental implant

Outcome Measures

Primary Outcomes (1)

  • genetic polymorphisms associated with implant loss

    Identification of genetic polymorphisms that are associated with implant loss. It concerns only one evaluation (1 blood sample).

    after 3 to 6 years

Study Arms (2)

CONTROL: no dental implants lost

ACTIVE COMPARATOR

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: anamnesisProcedure: oral examinationProcedure: Blood sample

CASE: patients lost one or more implants

EXPERIMENTAL

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: anamnesisProcedure: oral examinationProcedure: Blood sample

Interventions

anamnesisOTHER

To update the anamnesis.

CASE: patients lost one or more implantsCONTROL: no dental implants lost
oral examinationPROCEDURE

A brief clinical oral examination will be performed.

CASE: patients lost one or more implantsCONTROL: no dental implants lost
Blood samplePROCEDURE

A blood sample will be taken to identify relevant genetic polymorphisms.

CASE: patients lost one or more implantsCONTROL: no dental implants lost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Interventions

Immunologic MemoryDiagnosis, OralBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Adaptive ImmunityImmunityImmune System PhenomenaDentistrySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Hugo De Bruyn, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

June 1, 2011

Primary Completion

August 5, 2013

Study Completion

August 5, 2013

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

BE(1)