Dental ImplantsNCT00313989
Evaluation of Osseo-integration After Placement of Dental Implants With Patients Receiving Radiotherapy for Buccopharyngeal Oncology
A study testing Evaluation of the success rate of implants in people with Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology. Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after the end of the radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Evaluation of the success rate of implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Aug 2015
- 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
- Patients receiving radiotherapy (6 weeks later or at least 3 months before) for buccopharyngeal oncology
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology. Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after the end of the radiotherapy
- Conditions
- Dental Implants
- Being tested
- Evaluation of the success rate of implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the success rate of implantsProcedure or surgery
Evaluation of the success rate of implants
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of implants of patients receiving radiotherapy. | Experimental | Not described Receives: Procedure: Evaluation of the success rate of implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovering and ingrowing of dental implants
Measured: 4 to 6 months
Success rate of dental implants
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startSep 2007
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00313989
- Sponsor's protocol ID
- 2006/125
- Status last verified
- Dec 2014
- First submitted
- 11 Apr 2006
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Osseo-integration After Placement of Dental Implants With Patients Receiving Radiotherapy for Buccopharyngeal Oncology
- ClinicalTrials.gov ID
- NCT00313989
- Acronym / sponsor ID
- 2006/125
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Apr 2006 (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.
Follow up of implants with patients receiving radiotherapy for buccopharyngeal oncology. Implants will be placed 6 weeks before start of the radiotherapy or at least 3 months after the end of the radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of implants of patients receiving radiotherapy. | Experimental | Procedure: Evaluation of the success rate of implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving radiotherapy (6 weeks later or at least 3 months before) for buccopharyngeal oncology
Key exclusion criteria (0 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 |
|---|---|---|
| Evaluation of the success rate of implantsEvaluation of the success rate of implants | Procedure or surgery | Evaluation of implants of patients receiving radiotherapy. |
Primary outcome
Recovering and ingrowing of dental implants
Time frame: 4 to 6 months
Success rate of dental implants
Time frame: 4 to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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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 Evaluation of the success rate of implants in people with 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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 21 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 was withdrawn before enrolling participants, so there are no results.
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?
Recovering and ingrowing of dental implants (time frame: 4 to 6 months). The study lists 2 primary outcomes in all. 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 21 Dec 2022.