This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant into the new bone in a prosthetically guided position.
Eleven patients presenting with the need of an implant retained restoration in the posterior mandibula and an alveolar ridge of maximum 4.5 mm width. A clinical examination, x- rays and Cone Beam CT(CBCT) are accessed. A sample of the patients' bone marrow is extracted from the posterior alveolar ridge, immediately shipped to the collaborating good clinical practice (GCP) cell laboratory for cell expansion, and returned after 21 days. The stem cells mixed with Bi Calcium Phosphate (BCP) are then used to augment the alveolar ridge. The material is covered with a titanium reinforced membrane before closure of the site. After four to six months a bone biopsy is performed and implants are installed in the regenerated bone. The patient will be followed after 1, 2, 3, and 5 years where implant stability will be assessed. Furthermore the new formed bone will be clinically and radiologically assessed at the same time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Augmentation of narrow alveolar ridge with BCP and MSC
Institute of Clinical Dentistry, University of Bergen
Bergen, Hordaland, Norway
Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments.
CBCT
Time frame: Four to six months post augmentation
Implant stability
Implant stability measurement using the Ostell system
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety of MSC in patients. Adverse events
Time frame: 5 years
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