A pilot study to investigate safety and effectiveness of Collagen Matrix 10808 to increase soft tissue thickness simultaneous to GBR and implant placement

Not Applicable

• Conditions: K08.1; Loss of teeth due to accident, extraction or local periodontal disease

• Registration Number: DRKS00006005
• Lead Sponsor: Geistlich Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-21
• Study Completion: 2016-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients will be included in the study if they present all of the following conditions:
• Signed informed consent
• Age 18 years or older
• Absence of significant medical conditions
• Patients with healthy or effectually treated periodontal conditions
• Full-Mouth Plaque score less than 25% (O’Leary et al. 1972)
• Candidate for single tooth replacement in the anterior maxilla
• Implant sites with the need for contour augmentation using GBR (Chen & Buser 2009)
• Implant sites which allow the concept of early implant placement after tooth extraction

Exclusion Criteria

Patients will not be included in the study if they present one of the following conditions:
• General contraindications for dental and/or surgical treatments
• Immunosuppressant, corticosteroid or bisphosphonate therapy
• Inflammatory or autoimmune disease of oral cavity
• History of malignancy, radiotherapy or chemotherapy for malignancy within the past five years.
• Smokers
• Uncontrolled diabetes
• Pregnant or lactating women
• Women of child bearing age, not using a standard accepted method of birth control
• Allergy to collagen
• Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this pilot study is to investigate the safety of Collagen Matrix 10808 in the indication of increasing soft tissue thickness simultaneous to GBR (guided bone regeneration) and implant placement. The GBR ist the standard procedure of the bone increase using the bone substitute material and the barrier membrane. The safety will be recorded according to the wound healing complications (wound closure, dehiscence, inflammation, swelling), which might be related to the Colagen Matrix.

Secondary Outcome Measures

Name	Time	Method
As secondary objectives effectiveness and esthetic parameters will be investigated. The gain of the soft tissue volume will be measured through 3-D analysis (interoral scans and radiologically scanned impressions) in the beginning of the study and at day 14, 30 and 56. Contemporaneously the thickness of the soft tissue will be measured using the ultrasound device. The esthetics of the tissue will be measured at the end of the study (day 56) according to the surface-structure (Colour, Form, Contour) and compared with the neighbouring soft tissue. A further objective is to define the appropriate surgical procedure, which will be obtained using a standardized questionnaire completed by the surgeon.