Randomized controlled clinical investigation to evaluate treatment concept forreconstruction of atrophied alveolar ridge using Collagenated Xenogeneic Bone Block(CXBB) compared to autogenous bone block (ABB) treatment
- Conditions
- reconstruction of atrophied alveolar in patients with partial edentulism
- Registration Number
- DRKS00012322
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 67
Written informed consent
- Age 18 years or older
- Partial edentulism
- Surgical site characteristics:
- Atrophied alveolar ridge with one or more adjacent missing teeth
- Atrophied alveolar ridge with residual ridge width of = 4 mm
- Sufficient bone height at the surgical site for implant placement
- General contraindications for dental and/or surgical treatments
- Periodontitis
- Peri-implantitis
- Probing depth > 4mm at the adjacent teeth
Inadequate oral hygiene (PI>1)
- Knife-edge morphology of the alveolar ridge
- Insufficient bone for bone block harvesting from ramus mandibulae
- Edentulous area not larger than 4 missing teeth
- Implants adjacent to the surgical site
- Inflammatory disease of oral cavity
- Immunological impairment
- Allergy to collagen
- Diabetes
- History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
- Previous, concurrent or planned radiotherapy of head area
- Concurrent or previous immunosuppressant, bisphosphonate, high-dose or long-term corticosteroid therapy
- Smokers or subjects who did not quit smoking at least 3 months prior to the surgery
- Pregnant or lactating women
- Women of child bearing age, who are not using a highly effective method of birth control
- Participation in an investigational device, drug or biologics study within the last 26 weeks
prior to the study start
- Participation in any other clinical investigation during the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method