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Reconstruction of Jaw Bone Using Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT02751125
Recruitment Status : Enrolling by invitation
First Posted : April 26, 2016
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
University of Ulm
Haukeland University Hospital
Université de Nantes
Information provided by (Responsible Party):
Cecilie Gjerde, University of Bergen

Brief Summary:
This pilot study is aimed to reconstruct atrophied posterior alveolar mandibular ridges using biomaterial and autologous bone marrow derived stem cells (BMMSC) and to insert an implant into the new bone in a prosthetically guided position.

Condition or disease Intervention/treatment Phase
Bone Atrophy Drug: BCP with autologous mesenchymal stem cells (MSC). Phase 1

Detailed Description:

Eleven patients presenting with the need of an implant retained restoration in the posterior mandibula and an alveolar ridge of maximum 4.5 mm width.

A clinical examination, x- rays and Cone Beam CT(CBCT) are accessed. A sample of the patients` bone marrow is extracted from the posterior alveolar ridge, immediately shipped to the collaborating good clinical practice (GCP) cell laboratory for cell expansion, and returned after 21 days. The stem cells mixed with Bi Calcium Phosphate (BCP) are then used to augment the alveolar ridge. The material is covered with a titanium reinforced membrane before closure of the site. After four to six months a bone biopsy is performed and implants are installed in the regenerated bone.

The patient will be followed after 1, 2, 3, and 5 years where implant stability will be assessed. Furthermore the new formed bone will be clinically and radiologically assessed at the same time.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Jaw Bone Reconstruction Using a Combination of Autologous Mesenchymal Stem Cells and Biomaterial Prior to Dental Implant Placement
Actual Study Start Date : June 2014
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Augmentation of new alveolar bone
Augmentation of atrophied alveolar ridge with mesenchymal stem cells( MSC) and bis calcium phosphate(BCP)
Drug: BCP with autologous mesenchymal stem cells (MSC).
Augmentation of narrow alveolar ridge with BCP and MSC
Other Name: MSC and BCP




Primary Outcome Measures :
  1. Amount of newly formed bone induced by MSCs and the bone substitute. These measurements are based on radiological assessments. [ Time Frame: Four to six months post augmentation ]
    CBCT


Secondary Outcome Measures :
  1. Implant stability [ Time Frame: 12 months ]
    Implant stability measurement using the Ostell system

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 5 years ]
    Safety of MSC in patients. Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients presenting with an indication for an implant and wanting implant-borne prosthetic restoration.

  • Patients presenting with lateral or vertical bone loss (focusing lateral bone loss) of the mandible behind the canine tooth.
  • Lateral (width 5 mm or less) bone loss preventing the insertion of an implant without prior bone augmentation.
  • Endentate for more than 6 months in the region requiring reconstruction.
  • Endentate concerning at least 2 missing teeth in the region requiring reconstruction.
  • Absence of clinical signs of infection in the region requiring reconstruction.
  • Patients presenting with good dental hygiene (subjective criteria)
  • Patients not presenting with any major oral pathologies.
  • Dental crest size less than 5 mm.

General criteria:

  • Adult patients over 18 and under 80 years of age.
  • Patients in good general health presenting with a complete blood count and renal and hepatic function values within normal limits (confirmed by local laboratory tests).
  • Patients with the capacity to understand medical information and give their informed consent.

Exclusion Criteria:

ocal criteria:

  • Patients presenting with clinical or radiological signs of bone infection (acute or chronic osteomyelitis).
  • Residual dentition close to the area requiring reconstruction with untreated endodontic disorder (apical granuloma or apical cyst).
  • Untreated oral infection (cellulitis, periodontitis).
  • Patients with poor hygiene (subjective criteria).
  • Surgical procedure undertaken in the area requiring reconstruction less than 6 months prior to the bone graft.
  • History of malignant tumors of the upper airways / digestive tract or of the jaw.
  • History of or scheduled cervico-facial radiation therapy.

General criteria:

  • The patient suffers from any serious coagulation disorders that could require substitution therapy
  • The patient is receiving VKA therapy, which should be adjusted if necessary so that the INR does not exceed 2.5
  • The patient has history of allergy to iodine or to local anesthetics(sulfites, etc.)., or a history of hematoma, or hemorrhage or blood coagulation disorders
  • The patient has received localized iliac crest radiotherapy contraindicating withdrawal from the irradiated site
  • The patient has major skin lesions or diseases.
  • Patients presenting with bone metabolism disorders: hypophosphatemia, primary parathyroid osteitis or that is secondary to chronic renal insufficiency or osteomalacia, Paget's disease, vitamin D-related disorders, osteoporosis.
  • Pregnant or breastfeeding women or women not using effective contraception if they are of childbearing age.
  • Patients presenting with cancerous disorders (carcinoma, sarcoma, leukemia, lymphoma) or psychiatric disorders or with uncontrolled systemic diseases (diabetes, hypertension), or chronic renal disease.
  • Severe bruxism.
  • History of chemotherapy.
  • Smoking or alcohol addiction. Occasional consumption of alcohol and/or smoking will be noted in the case report form.
  • Patients with an ASA score of 0 or 1, incapable of tolerating general anesthesia.
  • Immunosuppression
  • Body mass index outside the normal range, particularly >30 because of increased surgical risk at the time of BM harvesting from the iliac crest.
  • Risk of remote infection (orthopedic prosthesis implanted in the previous 6 months, patients presenting with a high risk of infective endocarditis, presence of pulmonary arteriovenous shunt, etc.).
  • HIV, HTLV and/or syphilis seropositivity.
  • Hepatitis B or C infection.
  • Active autoimmune disease.
  • History of immunosuppressant treatment or bone marrow treatment.
  • Administration of treatment interfering with bone metabolism.
  • Patients requiring antibiotic prophylaxis before any dental procedure
  • Patients reticent to undergo dental care or periodontal treatment
  • Concomitant treatments: history of treatment or current treatment with bisphosphonates, long term corticosteroid treatment.

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): NCT02751125


Locations
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Norway
Institute of Clinical Dentistry, University of Bergen
Bergen, Hordaland, Norway, 5008
Sponsors and Collaborators
University of Bergen
University of Ulm
Haukeland University Hospital
Université de Nantes
Investigators
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Principal Investigator: Cecilie Gjerde, DDS University of Bergen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cecilie Gjerde, Assosiate Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02751125     History of Changes
Other Study ID Numbers: 2012-003139-50
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cecilie Gjerde, University of Bergen:
Mesenchymal stem cells
bone augmentation
bone regeneration

Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical