Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting

  • STATUS
    Recruiting
  • End date
    Sep 23, 2024
  • participants needed
    150
  • sponsor
    University of Bergen
Updated on 23 January 2021
dental implantation
bone graft

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.

Description

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.

Details
Condition Alveolar Bone Loss
Treatment Autologous bone graft, Advanced medicinal Therapy (MSC combined with biomaterial)
Clinical Study IdentifierNCT04297813
SponsorUniversity of Bergen
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note