Randomized, controlled, clinical trial for clinical, functional, and histomorphometrical evaluation of bone substitute materials in combination with PRF in use for socket preservatio
Not Applicable
- Conditions
- Bone- and soft tissue regeneration after tooth extractionK08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00019228
- Lead Sponsor
- niversitätsklinikum derGoethe-Universität Frankfurt am MainKlinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Age 18 to 98 years
- Patients informed consent
- One or more tooth/teeth not worth to be preserved
- Patients is suitable for two-timed procedure
- Patient agrees to follow all study related instructions (eg. instruction regarding oral hygiene, compliance regarding follow-up visits and treatments)
Exclusion Criteria
- previous augmentations in the defect area
- uncontrolled diabetes (non-compliance regarding physicians instruction for treatment, diet, and/or alcohol consumption; A1c-Level above 8%)
- non-compliance regarding study-related instructions
- active periodontal disease at the remaining teeth
- mucosal disease in defect area
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone gain in augmentation bed / supposed area for implantation
- Secondary Outcome Measures
Name Time Method - Implant survival<br>- Implant success<br>- Change in bone volume in augmentation area / planned implant area<br>- Histological evaluation ratio of: vial bone, residual bone substitute material, connective tissue, further non-bone tissue <br>- Soft tissue healing<br>- Evaluation of oral health via questionnaire (Oral Health Impact Profile questionnaire OHIP-14)<br>- Peri-implant soft tissue and hard tissue changes<br>- Biological or technical complications<br>- Bone-to-implant contact throughout study via radiological parameter