soft-tissue augmentation aruond dental implants K08.1
Conditions
Interventions
Group 1: soft-tissue Augmentation with autogenous connective tissue graft
(Observational study)
Group 2: soft-tissue Augmentation with Collagen matrix
( observational study)
Sponsors
Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Successful participation and tooth restoration in study 10860-112 • Ability to fully understand the nature of the proposed long-term follow-up study and ability to sign the informed consent form
Exclusion criteria
Exclusion criteria: • Severe trauma to implant site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucosal thickness at the buccal aspect of FibroGide® compared to the autogenous soft tissue graft with respect to 5 years after the insertion of the final reconstructions. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Performance: - Mucosal thickness and tissue volume 3 years after insertion of the final reconstructions - Peri-implant tissue volume 5 years after the insertion of the final reconstructions - Peri-implant health and the height of the papilla - Esthetic outcomes (PES) • Patient-reported outcome measures (PROMs) - Assessment of patient satisfaction in respect to soft tissue appearance using an adapted VAS questionnaire • Safety - Recording of any AE Recording of concomitant medication | — |
Countries
Germany, Spain, Switzerland
Contacts
Public ContactDaniel Thoma
Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
Outcome results
None listed