Non-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)

Non-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) - GFG f-up-study 123

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011588

Enrollment

Registered

2017-01-27

Start date

2017-01-16

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

K08.1

Interventions

Group 1: 10808-113: soft tissue Augmentation with a Collagen sponge (CM-10808) simultaneous to GBR and implant palcement in single tooth gaps. non-interventional longterm Observation of the stability

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Countries

Switzerland

Contacts

Public ContactVivianne Chappuis

Zahnmedizinische Kliniken der Universität Bern, Klinik für Oralchirurgie und Stomatologie

vivianne.chappuis@zmk.unibe.ch+413031 632 49 05

Outcome results

None listed

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