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

Geistlich Pharma AG0 sites10 target enrollmentMarch 21, 2014

Overview

No summary available.

Registry

who.int

Start Date

March 21, 2014

End Date

January 12, 2016

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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

•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.
•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