A multicentre clinical trial; Alveolar bone augmentation using MesenchymalStem Cells and biphasic calcium phosphate granules prior to dentalimplants - BEHANDLING
- Conditions
- Patients in need of dental implant(s) in the upper and lower jaws withpresence of bone defects with loss in vertical height and < than 4 mm inlateral widthTherapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
- Registration Number
- EUCTR2018-004046-41-ES
- Lead Sponsor
- niversity of Bergen,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
• Need an dental implant
Can understand and sign informed consent
• Age 18 years or older
• Insufficient bone ridge width and or height at the recipient site for
implant placement
• Healthy oral mucosa, at least 2 mm keratinized
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• General contraindications for dental and/or surgical treatments
• Thin keratinized mucosa (< 1mm)
• Inflammatory and autoimmune disease of the oral cavity
• Uncontrolled diabetes
• History of malignant diseases
• Concurrent or previous radiotherapy of head and neck region
• Concurrent or previous immunosuppressant, bisphosphonate or high
dose corticosteroid therapy
• Current Smokers
• Pregnant or lactating women
• Women of child bearing age, who are not using a highly effective
method of birth control
• Participation in an investigational device, drug or biologics study
within the last 24 weeks prior to the study start
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method