on-interventional long-term follow-up observation of the stability of the augmented soft tissue around final restorations following previous soft tissue augmentation simultaneous to GBR and implant placement in single tooth gaps in the clinical investigation . (10808-113)
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00011588
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Patients will be included in the study if they present all of the following conditions:
1. Written informed consent
2. Successful soft tissue volume augmentation with collagen matrix 10808 in the study 10808-113
3. Implant survival at the treated site in study 10808-113
4. Final restoration at implant site
5. Ability to fully understand the nature of the proposed long-term follow-up study
Patients will not be included in the study if they present one of the following conditions:
1. Second soft tissue augmentation at target site of study 10808-113 since completion of study 10808-113
2. Severe trauma to implant site
3. Orthodontic treatment in the same quadrant
4. Participation in a clinical study interfering with the objective of this non-interventional long-term follow-up observation
5. Newly diagnosed diseases interfering with bone or soft-tissue metabolism
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate long-term stability of augmented mucosal soft tissue as dimensional changes of facial mucosa between 2 and 6 years post-surgery using cone beam computed tomography (CBCT, 3D Analysis)
- Secondary Outcome Measures
Name Time Method The secondary objective is to assess the esthetic outcome after 2 and 6 years post-surgery in study 10808-113 by means of the modified Pink Esthetic Score (modPES, nach Belser et al., 2009).