Retrospective, mono-centric post-market clinical follow-up study on the use of Cerasorb® Foam for socket preservation in dental surgery
- Registration Number
- DRKS00028789
- Lead Sponsor
- curasan AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
Patients who have been treated according to the intended use and instructions for use of Cerasorb Foam and have undergone dental surgery for filling and reconstruction of two-walled and multi-walled non-infected bone, with existing documentation for:
- diagnosis of tooth not worthy of preservation
- surgical treatment of tooth extraction, including digital volume tomography (DVT) measurement of dental alveolus according to AWMF guidelines 083-005 and 083-011
- removal of stitches (safety visit)
- implant placement with prior DVT follow-up measurement of dental alveolus
Patients whose diagnosis does not fall within the indications, or whose medical condition is one of the contraindications for Cerasorb Foam, which are:
- Acute and chronic infections in the operative field
- Severe metabolic disorders, such as severe, uncontrolled, or poorly controlled diabetes or bone diseases which impair bone or wound healing
- Disorders of calcium metabolism - Steroid treatment - Drugs that interfere with calcium metabolism
- Immunosuppressive therapy
- Endocrine bone disease
- Radiation therapy
- Nicotine abuse
- Known allergies to porcine collagen or other protein allergies.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Socket preservation [clinical performance]<br>
- Secondary Outcome Measures
Name Time Method - Inflammation after tooth extraction [safety]<br>- Implant characteristics (timing, position, length, diameter, torque, manufacturer, type)<br>