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

Tooth Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356770
• Other study ID #: 10860
• Secondary ID: DRKS00003586CIV-
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2019
• Source: Geistlich Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Soft Tissue Deficiency
• Tooth Loss

Intervention

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.

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.

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Geistlich Pharma AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of Adverse Events		from Day 0 to Day 90
Secondary	Closure of the wound		at Day 7, 30, 90
Secondary	Presence of Swelling		at Day 7, 30, 90
Secondary	Oral health impact profile (OHIP-G14) score		at day 0, 7, 90
Secondary	Daily Mefenaminacid consumption		between Day 0 and Day 7
Secondary	Evaluation of pain using a VAS(Visual Analogue Scale) score daily		between Day 0 and day 7 and at Day 30 and 90
Secondary	Surgery time		at surgery
Secondary	Qualitative histological assessment regarding matrix degradation and safety parameters		at day 90
Secondary	Gain in mucosal soft tissue thickness by 3D volumetric analysis		at day 90, compared to day 0
Secondary	Gain in mucosal soft tissue thickness measured by trans-mucosal probing		at day 30 compared to day 0
Secondary	Keratinized Tissue width (mm)		at day 0 and at day 90
Secondary	Probing Depth (mm)		at day 0 and at day 90
Secondary	Clinical Attachment Level (mm)		at day 0 and at day 90
Secondary	Bleeding of Probing (0/1)		at day 0 and at day 90
Secondary	Plaque Index (0-3)		at day 0 and at day 90
Secondary	Recession depth (mm)		at day 0 and at day 90