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

March 10, 2020 updated by: University of Bergen

Randomized Controlled Clinical 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 Grafting

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5230
  • France
  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5009
        • Recruiting
        • University of Bergen, Institute of Clonical Dentistry
        • Contact:
        • Contact:
  • Spain
      • Barcelona, Spain, 08195
        • Recruiting
        • Universitat Internacional de Catalunya
        • Contact:
          • Jordi Caballe Serrano, DDS
          • Phone Number: +34 6 96 54 03 64
          • Email: jordicase@uic.es
        • Contact:
    • Calle Fernando De Castro Rodriguez,
      • Madrid, Calle Fernando De Castro Rodriguez,, Spain, 28040
        • Recruiting
        • Universidad Complutense de Madrid
        • Contact:
          • Mariano Sanz, Prof
          • Phone Number: +34 913 942 010
          • Email: marsan@ucm.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.
Procedure: Autologous bone graft
Augmentation of the alveolar ridge with bone graft
Experimental: Test
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone width
Time Frame: 0-5 months
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
0-5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain postoperatively in the two different treatments
Time Frame: 21 months
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."
21 months
Radiological examination of bone volume
Time Frame: 21 months
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.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Assistance Publique - Hôpitaux de Paris
University of Aarhus
Universidad Complutense de Madrid
University of Ulm
European Commission
Université de Nantes
Universitat Internacional de Catalunya

Investigators

  • Principal Investigator: Mariano Sanz, Professor, Universidad Complutense de Madrid
  • Principal Investigator: Else Marie Pinholt, Professor, Syddansk Universitet SDU (University Hospital of Southern Denmark)
  • Principal Investigator: Federico Hernandez-Alfaroo, Professor, Universitat Internacional de Catalunya
  • Principal Investigator: Alain Hoornaert, DDS, CHU Nantes, Centre de Soins Dentaires
  • Principal Investigator: Frederik Gaultier, PhD/DDS, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-001227-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participants data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available after study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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