Randomized controlled clinical study to investigate effectiveness and safety of a Collagen Matrix 10808 for soft tissue volume augmentation after implant placement in single tooth gaps compared to autogenous connective tissue graft
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00003586
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
- Secondary Outcome Measures
Name Time Method Safety endpoints: <br>- Assessment of AEs<br>- Closure of the wound at Day 7, 30, 90<br>- Presence of Swelling at Day 7, 30, 90<br>- Oral health impact profile (OHIP-G14) score at 0, 7, 90<br>- Daily Mefenaminacid consumption between Day 0 and Day 7<br>- Evaluation of pain using a VAS score daily between Day 0 and day 7 and at Day 30 and 90<br>- surgery time<br>- Qualitative histological assessment regarding matrix degradation and safety parameters at Day 90<br><br>Effectiveness endpoints: <br>- Gain in mucosal soft tissue thickness at day 90, compared to day 0 based to a 3D volumetric analysis<br>- Gain in mucosal soft tissue thickness measured at day 30 compared to day 0 by trans-mucosal probing<br>- KT width, PD, CAL, BOP, PI at day 0 and at day 90