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

Not Applicable

Completed

• Conditions: Soft Tissue Deficiency; Tooth Loss
• Interventions: Device: Collagen Matrix 10808; Procedure: Connective tissue graft

• Registration Number: NCT02356770
• Lead Sponsor: Geistlich Pharma AG

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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• 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 (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Matrix 10808	Collagen Matrix 10808	Mucosal split-thickness flap in combination with the Collagen Matrix 10808.
Connective tissue graft (gold standard)	Connective tissue graft	Mucosal split-thickness flap in combination with the connective tissue graft.

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	at day 90 compared to day 0 (Baseline)

Secondary Outcome Measures

Name	Time	Method
Probing Depth (mm)	at day 0 and at day 90
Plaque Index (0-3)	at day 0 and at day 90
Qualitative histological assessment regarding matrix degradation and safety parameters	at day 90
Gain in mucosal soft tissue thickness by 3D volumetric analysis	at day 90, compared to day 0
Assessment of Adverse Events	from Day 0 to Day 90
Presence of Swelling	at Day 7, 30, 90
Surgery time	at surgery
Keratinized Tissue width (mm)	at day 0 and at day 90
Bleeding of Probing (0/1)	at day 0 and at day 90
Oral health impact profile (OHIP-G14) score	at day 0, 7, 90
Gain in mucosal soft tissue thickness measured by trans-mucosal probing	at day 30 compared to day 0
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
Clinical Attachment Level (mm)	at day 0 and at day 90
Closure of the wound	at Day 7, 30, 90
Recession depth (mm)	at day 0 and at day 90

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland