NCT02751125

Reconstruction of Jaw Bone Using Mesenchymal Stem Cells

Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bone Atrophy

Interventions

Type	Name	Description
DRUG	BCP with autologous mesenchymal stem cells (MSC).	Augmentation of narrow alveolar ridge with BCP and MSC

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-03-01
• Completion: 2020-03-01
• First posted: 2016-04-26
• Last updated: 2020-03-03

Locations

1 site across 1 country: Norway