Randomized, controlled, clinical trial for evaluation of the influence of platelet rich fibrin (PRF) in combination with bone substitute materials in use for regeneration of extraction sockets
Not Applicable
Recruiting
- Conditions
- Bone- and soft tissue regeneration after tooth extractionK08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00024023
- Lead Sponsor
- niversitätsklinikum der Goethe-Universität Frankfurt am Main Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
informed consent
- tooth/teeth in need of extraction
- patients planed for dental restoration via implantation
- indication for socket preservation / ridge preservation
- patients is suitable for two-timed intervention
- patient will follow study-related requirements and guidelines
Exclusion Criteria
- severe periodontal disease or acute pericoronitis at remaining dentition
- mucosal disease in treatment areas
- antibiotic treatment
- previous augmentation procedures in defect region
- uncontrolled diabetes
- alcohol abuse
- inability to follow post-surgery instructions
- inability to attend follow-up visits
- insufficiency to follow study-related requirements and guidelines
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone gain in augmented region planned for implantation<br>[3 months post-augmentation]
- Secondary Outcome Measures
Name Time Method - soft tissue healing (score 1-4) [7 days post-augmentation]<br>- implant survival [up to 6 months post-implantation]<br>- bone change in augmented region [3 months post-augmentation]<br>- histological evaluation of vital bone, residual bone substitute material, connective tissue [3 months post-augmentation]<br>- overall soft tissue healing [7 days post-surgery]<br>- Oral Health Impact Profile questionnaire (OHIP-14) [pre-/post-surgery]<br>- peri implant soft tissue and bone tissue changes [up to 6 months post-implantation]<br>- further complications [up to 9 months post-augmentation]<br>- implant-bone connection in follow-up according to radiological evaluation [up to 6 months post-implantation]