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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02356770
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Tooth Loss Soft Tissue Deficiency Device: Collagen Matrix 10808 Procedure: Connective tissue graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Assessment of Adverse Events [ Time Frame: from Day 0 to Day 90 ]
  2. Closure of the wound [ Time Frame: at Day 7, 30, 90 ]
  3. Presence of Swelling [ Time Frame: at Day 7, 30, 90 ]
  4. Oral health impact profile (OHIP-G14) score [ Time Frame: at day 0, 7, 90 ]
  5. Daily Mefenaminacid consumption [ Time Frame: between Day 0 and Day 7 ]
  6. 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 ]
  7. Surgery time [ Time Frame: at surgery ]
  8. Qualitative histological assessment regarding matrix degradation and safety parameters [ Time Frame: at day 90 ]
  9. Gain in mucosal soft tissue thickness by 3D volumetric analysis [ Time Frame: at day 90, compared to day 0 ]
  10. Gain in mucosal soft tissue thickness measured by trans-mucosal probing [ Time Frame: at day 30 compared to day 0 ]
  11. Keratinized Tissue width (mm) [ Time Frame: at day 0 and at day 90 ]
  12. Probing Depth (mm) [ Time Frame: at day 0 and at day 90 ]
  13. Clinical Attachment Level (mm) [ Time Frame: at day 0 and at day 90 ]
  14. Bleeding of Probing (0/1) [ Time Frame: at day 0 and at day 90 ]
  15. Plaque Index (0-3) [ Time Frame: at day 0 and at day 90 ]
  16. Recession depth (mm) [ Time Frame: at day 0 and at day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356770


Locations
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Switzerland
University of Zurich
Zurich, Switzerland, 8032
Sponsors and Collaborators
Geistlich Pharma AG
Investigators
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Study Director: Lorenz Uebersax, PhD Geistlich Pharma AG
Study Data/Documents: 1. Publication  This link exits the ClinicalTrials.gov site
Identifier: PMID: 27310522
A first publication was published concerning the primary outcome of the transmucosal measurements.
2. publicaton  This link exits the ClinicalTrials.gov site
Identifier: PMID: 28107560
2. publication concerning the volumetric changes of the soft tissue

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Responsible Party: Geistlich Pharma AG
ClinicalTrials.gov Identifier: NCT02356770    
Other Study ID Numbers: 10860
DRKS00003586 ( Registry Identifier: Deutsches Register Klinischer Studien )
CIV-11-12-003323 ( Other Identifier: EUDAMED )
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases