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Trial record 1 of 1 for:    NCT04297813
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Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting (Maxibone)

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ClinicalTrials.gov Identifier: NCT04297813
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborators:
Université de Nantes
University of Ulm
Universidad Complutense de Madrid
University of Aarhus
Universitat Internacional de Catalunya
Assistance Publique - Hôpitaux de Paris
European Commission
Information provided by (Responsible Party):
University of Bergen

Tracking Information
First Submitted Date  ICMJE February 25, 2020
First Posted Date  ICMJE March 6, 2020
Last Update Posted Date March 12, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • 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."
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
  • Safety of the treatment [ Time Frame: 21 months ]
    To evaluate the safety of the tested interventions by: - assessing adverse effects (AEs) and soft tissue healing (uneventful healing, wound dehiscence, membrane, exposure, redness, absence of inflammation, signs of infection, swelling) at 2 and 4 weeks and 5 months.
  • Efficacy of treatment: radiological examination of bone volume [ Time Frame: 21 months ]
    To evaluate the efficacy of the treatment and 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial with advanced therapy medicinal product
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alveolar Bone Atrophy
Intervention  ICMJE
  • Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)
    Augmentation of alveolar ridge with MSC and biomaterial
  • Procedure: Autologous bone graft
    Augmentation of the alveolar ridge with bone graft
Study Arms  ICMJE
  • Active Comparator: Control
    The gold standard; Bone block from the ramus of the nation will be transplanted to the alveolar ridge.
    Intervention: Procedure: Autologous bone graft
  • Experimental: Test
    Expanded, autologous mesenchymal stem cells in combination with biphasic calcium phosphate
    Intervention: Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kamal Mustafa, Professor +47 98497607 kamal.mustafa@uib.no
Contact: Cecilie Gjerde, DDS +47 55 58 64 41 cecilie.gjerde@uib.no
Listed Location Countries  ICMJE Denmark,   France,   Norway,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04297813
Other Study ID Numbers  ICMJE 2018-001227-39
2018-001227-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participants data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available after study completion
Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement
URL: http://maxibone.eu
Responsible Party University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE
  • Université de Nantes
  • University of Ulm
  • Universidad Complutense de Madrid
  • University of Aarhus
  • Universitat Internacional de Catalunya
  • Assistance Publique - Hôpitaux de Paris
  • European Commission
Investigators  ICMJE
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
PRS Account University of Bergen
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP