Soft Tissue Deficiency, Tooth Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECollagen Matrix 10808
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
PROCEDUREConnective tissue graft
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
Sponsors
Geistlich Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 | at day 90 compared to day 0 (Baseline) |
Secondary
| Measure | Time frame |
|---|---|
| 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 day 0, 7, 90 |
| Daily Mefenaminacid consumption | between Day 0 and Day 7 |
| Evaluation of pain using a VAS(Visual Analogue Scale) score daily | between Day 0 and day 7 and at Day 30 and 90 |
| Surgery time | at surgery |
| Qualitative histological assessment regarding matrix degradation and safety parameters | at day 90 |
| Assessment of Adverse Events | from Day 0 to Day 90 |
| Gain in mucosal soft tissue thickness measured by trans-mucosal probing | at day 30 compared to day 0 |
| Keratinized Tissue width (mm) | at day 0 and at day 90 |
| Probing Depth (mm) | at day 0 and at day 90 |
| Clinical Attachment Level (mm) | at day 0 and at day 90 |
| Bleeding of Probing (0/1) | at day 0 and at day 90 |
| Plaque Index (0-3) | at day 0 and at day 90 |
| Recession depth (mm) | at day 0 and at day 90 |
| Gain in mucosal soft tissue thickness by 3D volumetric analysis | at day 90, compared to day 0 |
Countries
Switzerland
Outcome results
None listed