A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants

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

The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.

Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.

The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.

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 (Bleeding of probing) 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