K08.1
Conditions
Interventions
Group 1: All patients in this pilot study will receive the Collagen Matrix 10808 simultaneously to implantation and GBR in order to obtain the increase of the soft tissue volume.
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Switzerland
Contacts
Public ContactVivianne Chappuis
Universität BernKlinik für Oralchirurgie und StomatologieZMK
Outcome results
None listed