Clinical trial NCT02356770: A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Soft Tissue Deficiency
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 (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

Primary outcomes:
measure: Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
timeFrame: at day 90 compared to day 0 (Baseline)
Secondary outcomes:
measure: Assessment of Adverse Events
timeFrame: from Day 0 to Day 90
measure: Closure of the wound
timeFrame: at Day 7, 30, 90
measure: Presence of Swelling
timeFrame: at Day 7, 30, 90
measure: Oral health impact profile (OHIP-G14) score
timeFrame: at day 0, 7, 90
measure: Daily Mefenaminacid consumption
timeFrame: between Day 0 and Day 7
measure: Evaluation of pain using a VAS(Visual Analogue Scale) score daily
timeFrame: between Day 0 and day 7 and at Day 30 and 90
measure: Surgery time
timeFrame: at surgery
measure: Qualitative histological assessment regarding matrix degradation and safety parameters
timeFrame: at day 90
measure: Gain in mucosal soft tissue thickness by 3D volumetric analysis
timeFrame: at day 90, compared to day 0
measure: Gain in mucosal soft tissue thickness measured by trans-mucosal probing
timeFrame: at day 30 compared to day 0
measure: Keratinized Tissue width (mm)
timeFrame: at day 0 and at day 90
measure: Probing Depth (mm)
timeFrame: at day 0 and at day 90
measure: Clinical Attachment Level (mm)
timeFrame: at day 0 and at day 90
measure: Bleeding of Probing (0/1)
timeFrame: at day 0 and at day 90
measure: Plaque Index (0-3)
timeFrame: at day 0 and at day 90
measure: Recession depth (mm)
timeFrame: at day 0 and at day 90
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: Geistlich Pharma AG
name: Lorenz Uebersax, PhD
role: STUDY_DIRECTOR
References: