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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss; Soft Tissue Deficiency
• Intervention / Treatment: Device: Collagen Matrix 10808; Procedure: Connective tissue graft

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen Matrix 10808; Mucosal split-thickness flap in combination with the Collagen Matrix 10808.	Device: Collagen 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.
Other: Connective tissue graft (gold standard); Mucosal split-thickness flap in combination with the connective tissue graft.	Procedure: Connective 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Assessment of Adverse Events	from Day 0 to Day 90
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
Gain in mucosal soft tissue thickness by 3D volumetric analysis	at day 90, compared to day 0
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

Collaborators and Investigators

• Sponsor: Geistlich Pharma AG
• Investigators: Study Director: Lorenz Uebersax, PhD, Geistlich Pharma AG

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 10860; DRKS00003586 (Registry Identifier: Deutsches Register Klinischer Studien); CIV-11-12-003323 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Study Data/Documents

1. 1. Publication
   Information identifier: PMID: 27310522
   Information comments: A first publication was published concerning the primary outcome of the transmucosal measurements.
2. 2. publicaton
   Information identifier: PMID: 28107560
   Information comments: 2. publication concerning the volumetric changes of the soft tissue