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

NCT02356770 | Completed

• 3 other identifiers: 10860DRKS00003586CIV-11-12-003323
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Soft Tissue Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Study Arms (2)

Collagen Matrix 10808

EXPERIMENTAL

Mucosal split-thickness flap in combination with the Collagen Matrix 10808.

Device: Collagen Matrix 10808

Connective tissue graft (gold standard)

OTHER

Mucosal split-thickness flap in combination with the connective tissue graft.

Procedure: Connective tissue graft

Interventions

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.

Collagen Matrix 10808

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.

Connective tissue graft (gold standard)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Implant placement at least 6 weeks and maximum 6 months prior enrolment
• Necessity of soft tissue augmentation in single tooth gap
• teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of \< 30%
• Basic periodontal examination (BPE \<2)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (1)

University of Zurich

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Lorenz Uebersax, PhD

  Geistlich Pharma AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: February 5, 2015
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

CH (1)