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Retrospective, mono-centric post-market clinical follow-up study on the use of Cerasorb® Foam for socket preservation in dental surgery

Retrospective, mono-centric post-market clinical follow-up study on the use of Cerasorb® Foam for socket preservation in dental surgery - ReSORB

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028789
Enrollment
54
Registered
2022-05-09
Start date
2022-05-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

Interventions

Group 1: Assessments related to clinical performance measure socket preservation, which is routinely evaluated by digital volume tomography (DVT) scans at visits 1 (baseline, immediately after tooth e

Sponsors

curasan AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
- Socket preservation [clinical performance]

Secondary

MeasureTime frame
- Inflammation after tooth extraction [safety] - Implant characteristics (timing, position, length, diameter, torque, manufacturer, type)

Countries

Germany

Contacts

Public ContactFrank Palm

Klinikum Konstanz

frank.palm@glkn.de+49 (07531) 51533

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026