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The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension')

The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') - Flap tension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025804
Enrollment
60
Registered
2021-09-09
Start date
2022-03-11
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

Soft-tissue dehiscence in the upper jaw (single tooth implant or pontic)

Interventions

Group 1: Soft-tissue augmentation

Sponsors

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Maxillary single implant sites with two neighboring teeth or pontic sites with two neighboring teeth aimed for reconstruction with an FDP or an RBB • GBR procedures and implant surgeries at least 3 months ago (if performed) • Biologic or esthetic indication for a soft tissue augmentation • Clinical attachment level >80% at neighboring teeth

Exclusion criteria

Exclusion criteria: • Active periodontitis (PD =5mm) • Smoking of >10 cigarettes per day • General contraindications for dental and/or surgical treatment • Uncontrolled diabetes • Pregnancy or breast feeding • Disease affecting connective tissue metabolism (e.g. collagenases) • Allergy to collagen-based substitutes • Allergy against local anesthetics

Design outcomes

Primary

MeasureTime frame
Volumetric change from Baseline (visit 1) to 8 weeks of healing following soft tissue augmentation (visit 4), based on intraoral scans (STL-files)

Secondary

MeasureTime frame
• Initial soft tissue thickness (CBCT scan) • Flap tension at wound closure (measured with a high precision advanced force strain gauge) • Volume gain following surgery (Superimposition of STL files) • Flap thickness at surgery (with caliper) • Surgery time from first incision to last suture • Mucosal scarring index at 1 week following surgery

Countries

Switzerland

Contacts

Public ContactStefan Bienz

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin

stefan.bienz@zzm.uzh.ch+41 44 634 04 04

Outcome results

None listed

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