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Completed

NCT Number: NCT02356770

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

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Soft Tissue Deficiency Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen Matrix 10808

Device

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

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Geistlich Pharma AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2015
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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