Randomized, controlled, clinical evaluation of xenogene bone and soft tissue substitute materials (PURGO THE Graft, PURGO THE Cover) in ridge preservatio

Not Applicable

Recruiting

Conditions: K08.1
Loss of teeth due to accident, extraction or local periodontal disease

Registration Number: DRKS00031642

Lead Sponsor: Purgo Biologics Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

Patients with good hygienic oral conditions
- Patients in need of extraction of one or more teeth; in case of more teeth the defect sites have to be in different quadrants
- Patients with type 1 (intact alveolar) or type 2 sockets (compromised alveolar)
- No systemic diseases which could influence the outcome of the therapy
- Patients able to follow pre- and post-surgical instructions
- Patient with informed consent

Exclusion Criteria

- Patients with severe systemic disease
- Patients with uncontrolled diabetes
- Allergies to product components
- Untreated caries
- Alcohol/ drug abuse
- Patients not able to follow instructions
- Patients w/o informed consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone gain 3 months after ridge preservation procedure, evaluated via image analysis of radiological images compared to post-extraction

Secondary Outcome Measures

Name	Time	Method
1. Pain (VAS) - 7 days post extraction<br>2. Soft tissue healing up to 3 months after ridge preservation, evaluated via semi-quantitative image analysis of clinical photo documentation<br>3. Bone quality via Implant success and stability at implantation surgery 3 months post-extraction<br>4. Implant survival after 3 years<br>5. Radiological evaluation of bone change at augmentation/implant site after 3 years, compared to post-extraction and pre-implantation situation<br>6. Occurrence of complications (e.g. infection, periimplantitis, implant loss)<br>7. Evaluation of safety measures via occurrence of (S)AE ((serious) adverse events), and medical device related events up to 3 months post-extraction