Non-interventional long-term follow-up observation of soft tissue around final restorations following previous soft tissue augmentation in single tooth gaps

Non-interventional long-term follow-up observation of soft tissue around final restorations following previous soft tissue augmentation in single tooth gaps - GFG FUP 002

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017484

Enrollment

Registered

2019-06-24

Start date

2012-11-02

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: Study 10860-001: Collagen matrix 10808 Group 2: Study 10860-001: autogenous subepithelial connective tissue graft (SCTG)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The 20 patients who participated in the study 10860-001: 1. Successful soft tissue augmentation in study 10860-001; 2. Final restoration at implant site; 3. 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: 1. Newly developed diseases interfering with soft tissue regeneration (e.g. diabetes); 2. Peri-implant infection (not related to previously performed soft tissue regeneration) following the insertion of the final reconstruction; 3. Second soft tissue augmentation since completion of study 10860-001; 4. Severe trauma to implant site; 5. Orthodontic treatment in the same quadrant.

Design outcomes

Primary

Measure	Time frame
Effectiveness endpoints: 1. Assessment of long-term stability of mucosal soft tissue thickness around implants measured at day 0 (baseline) and 0.5, 1, 3 and 5 years by trans-mucosal probing; 2. Assessment of long-term stability of mucosal soft tissue thickness around implants based on a 3D volumetric analysis; 3. keratinized tissue width, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), periodontal index (PI) at day 0 (baseline) and after 0.5, 1, 3 and 5 years; 4. Aesthetic parameters (pink esthetic score (PES), papilla evaluation, soft tissue recession evaluation, spectroshade measurements) at day 0 (Baseline), 0.5, 1, 3 and 5 years.	—

Measure

Time frame

Effectiveness endpoints: 1. Assessment of long-term stability of mucosal soft tissue thickness around implants measured at day 0 (baseline) and 0.5, 1, 3 and 5 years by trans-mucosal probing; 2. Assessment of long-term stability of mucosal soft tissue thickness around implants based on a 3D volumetric analysis; 3. keratinized tissue width, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), periodontal index (PI) at day 0 (baseline) and after 0.5, 1, 3 and 5 years; 4. Aesthetic parameters (pink esthetic score (PES), papilla evaluation, soft tissue recession evaluation, spectroshade measurements) at day 0 (Baseline), 0.5, 1, 3 and 5 years.

—

Secondary

Measure	Time frame
Safety endpoints to be assessed are: 1. Assessment of AEs; 2. Oral health impact profile (OHIP-G14) score at day 0 (Baseline), and 0.5, 1, 3 and 5 years.	—

Countries

Switzerland

Contacts

Public ContactDaniel S. Thoma

Klinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde

info@zzm.uzh.ch+41 44 634 33 11

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 20, 2026