on-interventional follow-up observation of peri-implant soft tissues following previous soft tissue augmentation in single tooth gaps: a clinical multi-center study

• Conditions: soft-tissue augmentation aruond dental implants; K08.1; Loss of teeth due to accident, extraction or local periodontal disease

• Registration Number: DRKS00013354
• Lead Sponsor: niversität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

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

•Severe trauma to implant site

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
• Performance:<br>- Mucosal thickness and tissue volume 3 years after insertion of the final reconstructions <br>- Peri-implant tissue volume 5 years after the insertion of the final reconstructions <br>- Peri-implant health and the height of the papilla <br>- Esthetic outcomes (PES)<br>• Patient-reported outcome measures (PROMs)<br>- Assessment of patient satisfaction in respect to soft tissue appearance using an adapted VAS questionnaire <br>• Safety<br>- Recording of any AE<br>Recording of concomitant medication<br>