Patients in need of dental implant(s) in the upper and lower jaws with presence of bone defects with loss in vertical height and < than 4 mm in lateral width
Conditions
Interventions
Product Name: Células madre mesenquimales y fosfato cálcico bifásico microporoso (MBCP+)
Product Code: BEHANDLING
Pharmaceutical Form: Granules
INN or Proposed INN: Autologous Bone Marrow-derived mese
Sponsors
University of Bergen,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective: placement of dental implants in bone regenerated with a combination of autologous culture expanded mesenchymal stem cells and biomaterials.The principal objective is to assess if it is possible to insert an implant in the reconstructed area 5 months after the grafting procedure. This decision will be made based on radiological examination of bone volume and bone quality by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery;Secondary Objective: Evaluate new bone formation at 5-6 months assessed by clinical examination and CBCT. Evaluate the safety of the tested interventions by assessing adverse effects and soft tissue healing at 2 and 4 weeks and 5 months. Assess the morbidity with the procedure by measuring postoperative antiinflammatory medication and the degree of reported pain using a VAS scale. Assess patient's satisfaction with the surgical intervention and the prosthetic outcome by patient reported outcomes. The impact of the test treatments on the patient's overall quality of life will be assessed. Assess the fate of the transplanted MSCs by liquid biopsy technology at screening, and 2 weeks after the bone augmentation surgery. Bone promoting activity of the interventions by evaluating the core biopsies harvested during re-entry procedure at the sites by microcomputed tomography and histology. Evaluate the effectiveness of the interventions;Primary end point(s): At the end of the healing period (5-6 months), radiological and clinical examinations will be performed to determine whether or not the patient may have one or more dental implants inserted.;Timepoint(s) of evaluation of this end point: After 5-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): At 21 months;Timepoint(s) of evaluation of this end point: Once the implants have been inserted, periapical radiographs and clinical evaluation will assess the post-surgical follow-up up to 20 months after grafting. | — |
Countries
Norway, Spain
Contacts
Public ContactCecilie Gjerde
University of Berguen, Faculty of Medicin, Department of CLinical Dentistry
Outcome results
None listed