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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

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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Atrophy Combination Product: Advanced medicinal Therapy (MSC combined with biomaterial) Procedure: Autologous bone graft Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with advanced therapy medicinal product
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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."

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297813


Contacts
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Contact: Kamal Mustafa, Professor +47 98497607 kamal.mustafa@uib.no
Contact: Cecilie Gjerde, DDS +47 55 58 64 41 cecilie.gjerde@uib.no

Locations
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Denmark
Syddansk Universitet SDU (University Hospital of Southern Denmark) Recruiting
Odense, Denmark, 5230
Contact: Kristian Thesbjerg, DDS       kristian.thesbjerg@rsyd.dk   
Contact: Else Pinholt    +45 40 16 13 58    empinholt@health.sdu.dk   
France
Assistance Publique - Hôpitaux De Paris Recruiting
Créteil, France, 94010
Contact: Frederik Gaultier, PhD/DDS    +33 1 45 17 84 05    frederick.gaultier@parisdescartes.fr   
Contact: Bruno Gogly, DDS    +33 1 49 81 31 33    bruno.gogly@aphp.fr   
CHU Nantes, Centre de Soins Dentaires Recruiting
Nantes, France, 44000
Contact: Alain Hoornaert, DDS    +33 2 40 73 88 66    alain.hoornaert@univ-nantes.fr   
Contact: Claire Fourcade, DDS       clairefourcade@aol.com   
Norway
University of Bergen, Institute of Clonical Dentistry Recruiting
Bergen, Hordaland, Norway, 5009
Contact: Cecilie Gjerde, DDS    +4755586000    cecilie.gjerde@uib.no   
Contact: Kamal Mustafa, Prof    +4755586000    kamal.mustafa@uib.no   
Spain
Universidad Complutense De Madrid Recruiting
Madrid, Calle Fernando De Castro Rodriguez,, Spain, 28040
Contact: Mariano Sanz, Prof    +34 913 942 010    marsan@ucm.es   
Contact: Alberto Ortiz-Vigón, PhD/DDS    +34 9 44 15 89 02    alberto@ortizvigon.com   
Universitat Internacional De Catalunya Recruiting
Barcelona, Spain, 08195
Contact: Jordi Caballe Serrano, DDS    +34 6 96 54 03 64    jordicase@uic.es   
Contact: Maria Giralt, DDS    +34 6 96 54 03 64    mariagiralth@gmail.com   
Sponsors and Collaborators
University of Bergen
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
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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
Additional Information:
Publications:
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT04297813    
Other Study ID Numbers: 2018-001227-39
2018-001227-39 ( EudraCT Number )
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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

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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
Keywords provided by University of Bergen:
Maxilla
mandible,
MSC
RCT
Bone regeneration
Multicenter
Additional relevant MeSH terms:
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Alveolar Bone Loss
Atrophy
Pathological Conditions, Anatomical
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases