Peri-implantitis, implant loss and osteoradionecrosis in oral cancer patients
Recruiting
- Conditions
- non-healing dead bone due to irradiationosteoradionecrosisradiation osteomyelitis1006291510019190
- Registration Number
- NL-OMON39152
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients treated for cancer of the oral cavity receiving oral rehabilitation with dental implant surgery. (cases)
Patients treated for oral cancer with irradiation and dental implants, complicated by osteoradionecrosis.
Healthy subjects receiving implant surgery for missing dental elements. (controls)
Exclusion Criteria
Age <18
Legal incapacity
Patients with impaired bone metabolism (e.g. haemodialysis, hyperparathyroidism, osteomalacia) (registration, no inclusion).
Patients having used systemic immunosuppressive medication up to three months prior to the dental implant surgery (registration, no inclusion).
Patients allergic to tetracycline will be excluded for the tetracycline labelling of bone analysis exclusively.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Differences in histomorphometric parameters between healthy and irradiated<br /><br>human jaw bone and jaw bone involved in an osteoradionecrosis lesion.<br /><br><br /><br>- Gene expression profiles of irradiated oral mucosa and oral mucosa associated<br /><br>with an osteoradionecrosis lesion compared to healthy oral mucosa.<br /><br><br /><br>- Differences in cell surface characteristics (microplication and microvilli)<br /><br>of irradiated and non irradiated oral mucosa and oral mucosa associated with an<br /><br>osteoradionecrosis lesion. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Abnormalities in histomorphometric parameters in jaw bone of smokers in the<br /><br>control group and non-irradiated patients treated for a malignancy of the oral<br /><br>cavity compared to non-smoking controls.<br /><br><br /><br>- Genexpressieprofiles in oral mucosa of smokers in the control group as<br /><br>opposed to non-smokers and gene expression profiles of non-irradiated patients<br /><br>treated for a malignancy of the oral cavity compared to non smoking controls.<br /><br><br /><br>- Cell surface characteristics (microplications and microvilli) in the oral<br /><br>mucosa of smokers in the control group and in non-irradiated patienst treated<br /><br>for a malignancy of the oral cavity compared to non-smokers.<br /><br><br /><br>These parameters are important to filter the contributing effect of smoking and<br /><br>malignancy to oral tissue alterations in irradiated oral cancer patients. </p><br>