A Phase 3 interventional study of Advanced medicinal Therapy (MSC combined with biomaterial) and Autologous bone graft in Alveolar Bone Atrophy, sponsored by University of Bergen. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by University of Bergen · Phase 3, Interventional, and Treatment
A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.
A phase III multi center clinical trial, randomized and controlled.The study subject is lacking one or more sheet behind the canine in the upper or lower jaw, and the alveolar ridge is too narrow to place a dental implant. The test objects will have augmentation using autologous mesenchymal stromal cells and a biomaterial, biphasic Calcium Phosphate. The control is the traditional bone block from the ramus.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 48 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.
Procedure: Autologous bone graft
Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate
Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)
Augmentation of alveolar ridge with MSC and biomaterial
Augmentation of the alveolar ridge with bone graft
Change in bone width
Changes in linear measurements of bone width measured by CBCT.Principal assessment is linear change in bone width 2 mm below alveolar crest measured by means of CBCT images from baseline to 5 months after the regenerative surgery, immediately prior to implant placement
Time frame: 0-5 months
Pain postoperatively in the two different treatments
Assessed by VAS scale, the scale goes from 0 to 100, 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time frame: 21 months
Radiological examination of bone volume
To evaluate the formation of the new bone by assessing 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 by means of 3D CBCT images captured immediately prior to implant placement, 5-6 months after the regenerative surgery.
Time frame: 21 months
Plan to share: Yes — De-identified individual participants data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Bergen