Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Auto… (NCT04297813) | Clinical Trial Compass
CompletedPhase 3
Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
Denmark, France, Norway48 participantsStarted 2020-03-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy, non smoking patients in need of dental implants in the upper or lower jaw, with loss in vertical height and less that 4 mm in lateral width.
Exclusion Criteria:
* General contraindications for dental and/or surgical treatments
* Contraindications for both bone marrow harvesting and bone grafts
* History of any malignant diseases
* Concurrent or previous radiotherapy of head and neck region
* History of contagious diseases (HIV, HTLV and/or syphilis seropositivity, hepatitis B or C infection)
* Uncontrolled diabetes mellitis, e.g. patients with diabetes not regulated with medications or diet. This will be verified based on patient's history and concurrent HbA1c levels (HbA1c \> 53 mmol/mol).
* Inflammatory and autoimmune disease of the oral cavity.
* Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy.