DRKS00028789
Completed
Not Applicable
Retrospective, mono-centric post-market clinical follow-up study on the use of Cerasorb® Foam for socket preservation in dental surgery - ReSORB
curasan AG0 sites54 target enrollmentMay 9, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- curasan AG
- Enrollment
- 54
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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