Patients Treated by Means of 1 or More Dental ImplantsPolymorphismNCT01274442
Impact of Genetic Polymorphisms on Dental Implant Loss
A study testing anamnesis, oral examination and Blood sample in people with Patients Treated by Means of 1 or More Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Treated by Means of 1 or More Dental Implants
- What is being tested?
- anamnesis, oral examination and Blood sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2011to 5 Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dental implant surgery in the University Hospital in Ghent in 2004-2007.
- Case: dental implant loss
- Control: no dental implant loss
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case-control Study on the Impact of Genetic Polymorphisms on Dental Implant Loss.
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.
- Being tested
- anamnesis, oral examination, Blood sample
- Keywords
- dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anamnesisOther
To update the anamnesis.
oral examinationProcedure or surgery
A brief clinical oral examination will be performed.
Blood sampleProcedure or surgery
A blood sample will be taken to identify relevant genetic polymorphisms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: anamnesis; Procedure: oral examination; Procedure: 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. Receives: Other: anamnesis; Procedure: oral examination; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic polymorphisms associated with implant loss
Identification of genetic polymorphisms that are associated with implant loss. It concerns only one evaluation (1 blood sample).
Measured: after 3 to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study start1 Jun 2011
- Primary completion5 Aug 2013
- Study completion5 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated by Means of 1 or More Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo De Bruyn, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274442
- Sponsor's protocol ID
- 2010/771
- Acronym
- Polymorphism
- Status last verified
- Dec 2022
- First submitted
- 10 Jan 2011
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study on the Impact of Genetic Polymorphisms on Dental Implant Loss.
- ClinicalTrials.gov ID
- NCT01274442
- Acronym / sponsor ID
- Polymorphism / 2010/771
- Keywords
- dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 5 Aug 2013 (actual)
- Study completion
- 5 Aug 2013 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL: no dental implants lost | Active comparator | Other: anamnesis, Procedure: oral examination, Procedure: Blood sampleGroup 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. |
| CASE: patients lost one or more implants | Experimental | Other: anamnesis, Procedure: oral examination, Procedure: Blood sampleGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dental implant surgery in the University Hospital in Ghent in 2004-2007.
- Case: dental implant loss
- Control: no dental implant loss
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anamnesisTo update the anamnesis. | Other | CASE: patients lost one or more implants, CONTROL: no dental implants lost |
| oral examinationA brief clinical oral examination will be performed. | Procedure or surgery | CASE: patients lost one or more implants, CONTROL: no dental implants lost |
| Blood sampleA blood sample will be taken to identify relevant genetic polymorphisms. | Procedure or surgery | CASE: patients lost one or more implants, CONTROL: no dental implants lost |
Primary outcome
genetic polymorphisms associated with implant loss
Time frame: after 3 to 6 years
Identification of genetic polymorphisms that are associated with implant loss. It concerns only one evaluation (1 blood sample).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo De Bruyn, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anamnesis, oral examination and Blood sample in people with Patients Treated by Means of 1 or More Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic polymorphisms associated with implant loss (time frame: after 3 to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.