Back to resultsA Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants
Primary Purpose
Tooth Loss, Soft Tissue Deficiency
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Collagen Matrix 10808
Connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss
Eligibility Criteria
Inclusion Criteria:
- Implant placement at least 6 weeks and maximum 6 months prior enrolment
- Necessity of soft tissue augmentation in single tooth gap
- 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
- Basic periodontal examination (BPE <2)
- 18 years or older
- Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Exclusion Criteria:
- Heavy smoker (> 10 cigarettes per day)
- Probing depth greater than 4 mm
- Insulin dependent diabetes
- General contraindications for dental and/or surgical treatment
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
- Women of child bearing age, not using a standard accepted method of birth control
- Pregnancy or breast feeding
- Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
- Disease affecting connective tissue metabolism (e.g. collagenases).
- Allergy to collagen
- Participation in a clinical trial within the last six months
Sites / Locations
- University of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Collagen Matrix 10808
Connective tissue graft (gold standard)
Arm Description
Mucosal split-thickness flap in combination with the Collagen Matrix 10808.
Mucosal split-thickness flap in combination with the connective tissue graft.
Outcomes
Primary Outcome Measures
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Secondary Outcome Measures
Assessment of Adverse Events
Closure of the wound
Presence of Swelling
Oral health impact profile (OHIP-G14) score
Daily Mefenaminacid consumption
Evaluation of pain using a VAS(Visual Analogue Scale) score daily
Surgery time
Qualitative histological assessment regarding matrix degradation and safety parameters
Gain in mucosal soft tissue thickness by 3D volumetric analysis
Gain in mucosal soft tissue thickness measured by trans-mucosal probing
Keratinized Tissue width (mm)
Probing Depth (mm)
Clinical Attachment Level (mm)
Bleeding of Probing (0/1)
Plaque Index (0-3)
Recession depth (mm)
Full Information
NCT ID
NCT02356770
First Posted
December 18, 2014
Last Updated
February 22, 2019
Sponsor
Geistlich Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT02356770
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geistlich Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss, Soft Tissue Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen Matrix 10808
Arm Type
Experimental
Arm Description
Mucosal split-thickness flap in combination with the Collagen Matrix 10808.
Arm Title
Connective tissue graft (gold standard)
Arm Type
Other
Arm Description
Mucosal split-thickness flap in combination with the connective tissue graft.
Intervention Type
Device
Intervention Name(s)
Collagen Matrix 10808
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Time Frame
at day 90 compared to day 0 (Baseline)
Secondary Outcome Measure Information:
Title
Assessment of Adverse Events
Time Frame
from Day 0 to Day 90
Title
Closure of the wound
Time Frame
at Day 7, 30, 90
Title
Presence of Swelling
Time Frame
at Day 7, 30, 90
Title
Oral health impact profile (OHIP-G14) score
Time Frame
at day 0, 7, 90
Title
Daily Mefenaminacid consumption
Time Frame
between Day 0 and Day 7
Title
Evaluation of pain using a VAS(Visual Analogue Scale) score daily
Time Frame
between Day 0 and day 7 and at Day 30 and 90
Title
Surgery time
Time Frame
at surgery
Title
Qualitative histological assessment regarding matrix degradation and safety parameters
Time Frame
at day 90
Title
Gain in mucosal soft tissue thickness by 3D volumetric analysis
Time Frame
at day 90, compared to day 0
Title
Gain in mucosal soft tissue thickness measured by trans-mucosal probing
Time Frame
at day 30 compared to day 0
Title
Keratinized Tissue width (mm)
Time Frame
at day 0 and at day 90
Title
Probing Depth (mm)
Time Frame
at day 0 and at day 90
Title
Clinical Attachment Level (mm)
Time Frame
at day 0 and at day 90
Title
Bleeding of Probing (0/1)
Time Frame
at day 0 and at day 90
Title
Plaque Index (0-3)
Time Frame
at day 0 and at day 90
Title
Recession depth (mm)
Time Frame
at day 0 and at day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Implant placement at least 6 weeks and maximum 6 months prior enrolment
Necessity of soft tissue augmentation in single tooth gap
2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
Basic periodontal examination (BPE <2)
18 years or older
Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Exclusion Criteria:
Heavy smoker (> 10 cigarettes per day)
Probing depth greater than 4 mm
Insulin dependent diabetes
General contraindications for dental and/or surgical treatment
History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
Women of child bearing age, not using a standard accepted method of birth control
Pregnancy or breast feeding
Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Disease affecting connective tissue metabolism (e.g. collagenases).
Allergy to collagen
Participation in a clinical trial within the last six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Uebersax, PhD
Organizational Affiliation
Geistlich Pharma AG
Official's Role
Study Director
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
1. Publication
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/27310522
Available IPD/Information Identifier
PMID: 27310522
Available IPD/Information Comments
A first publication was published concerning the primary outcome of the transmucosal measurements.
Available IPD/Information Type
2. publicaton
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/28107560
Available IPD/Information Identifier
PMID: 28107560
Available IPD/Information Comments
2. publication concerning the volumetric changes of the soft tissue
Learn more about this trial
A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants
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