K08.1
Conditions
Interventions
Group 1: Collagen Matrix 10808
Group 2: Autogenous Connective Tissue Graft
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Implant placement at least 6 weeks and maximum 6 months prior enrolment 2. Necessity of soft tissue augmentation in single tooth gap 3. 2 teeth adjacent to each side of the defect have a mean BOP of < 30% 4. Basic periodontal examination (BPE <2) 5. 18 years or older 6. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures 7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Heavy smoker (> 10 cigarettes per day) 2. Probing depth greater than 4 mm 3. Insulin dependent diabetes 4. General contraindications for dental and/or surgical treatment 5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years 6. Women of child bearing age, not using a standard accepted method of birth control 7. Pregnancy or breast feeding 8. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs) 9. Disease affecting connective tissue metabolism (e.g. collagenases). 10. Allergy to collagen 11. Participation in a clinical trial within the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints: - Assessment of AEs - Closure of the wound at Day 7, 30, 90 - Presence of Swelling at Day 7, 30, 90 - Oral health impact profile (OHIP-G14) score at 0, 7, 90 - Daily Mefenaminacid consumption between Day 0 and Day 7 - Evaluation of pain using a VAS score daily between Day 0 and day 7 and at Day 30 and 90 - surgery time - Qualitative histological assessment regarding matrix degradation and safety parameters at Day 90 Effectiveness endpoints: - Gain in mucosal soft tissue thickness at day 90, compared to day 0 based to a 3D volumetric analysis - Gain in mucosal soft tissue thickness measured at day 30 compared to day 0 by trans-mucosal probing - KT width, PD, CAL, BOP, PI at day 0 and at day 90 | — |
Countries
Switzerland
Contacts
Public ContactDaniel S. Thoma
Clinic for Fixed and Removable Prosthodontics and Dental Material Science Center for Dental and Oral Medicine and Cranio-Maxillofacial Surgery University of Zurich
Outcome results
None listed