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

NCT ID: NCT02356770

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-07-31

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.

Conditions

Tooth Loss; Soft Tissue Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Collagen Matrix 10808

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

Group Type: EXPERIMENTAL

Collagen Matrix 10808

Intervention Type: 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 (gold standard)

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

Group Type: OTHER

Connective tissue graft

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz Uebersax, PhD

Role: STUDY_DIRECTOR

Geistlich Pharma AG

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Study Documents

Document Type: 1. Publication

A first publication was published concerning the primary outcome of the transmucosal measurements.

View Document

Document Type: 2. publicaton

2\. publication concerning the volumetric changes of the soft tissue

View Document

Other Identifiers

DRKS00003586

Identifier Type: REGISTRY

Identifier Source: secondary_id

CIV-11-12-003323

Identifier Type: OTHER

Identifier Source: secondary_id

10860

Identifier Type: -

Identifier Source: org_study_id