The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension')
Not Applicable
Recruiting
- Conditions
- Soft-tissue dehiscence in the upper jaw (single tooth implant or pontic)
- Registration Number
- DRKS00025804
- Lead Sponsor
- niversität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volumetric change from Baseline (visit 1) to 8 weeks of healing following soft tissue augmentation (visit 4), based on intraoral scans (STL-files)
- Secondary Outcome Measures
Name Time Method • Initial soft tissue thickness (CBCT scan)<br>• Flap tension at wound closure (measured with a high precision advanced force strain gauge)<br>• Volume gain following surgery (Superimposition of STL files)<br>• Flap thickness at surgery (with caliper)<br>• Surgery time from first incision to last suture<br>• Mucosal scarring index at 1 week following surgery