International trial. Reconstruction of jaw bone with a combination of biomaterial and autologous stem cells, before dental implant placement.

• Conditions: Men and women aged 18 years or more requiring jaw bone reconstruction prior to dental implant placement based on clinical and radiological examinations (CBCT Cone beam CT imaging). Areas suitable for reconstruction correspond to the mandible areas behind the canine teeth affected by lateral or vertical bone loss (focusing lateral bone loss). They must receive clear information about the study and give their informed consent to participate in the study.; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2012-003139-50-NO
• Lead Sponsor: niversity of Bergen, Faculty of medicin and dentistry, Dep. of Clinical Dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Local criteria:
o Patients presenting with an indication for an implant and wanting implant-borne prosthetic
restoration.
o Patients presenting with lateral or vertical bone loss (focusing lateral bone loss) of the mandible
behind the canine tooth.
o Lateral (width 5 mm or less) bone loss preventing the insertion of an implant without prior bone
augmentation.
o Endentate for more than 6 months in the region requiring reconstruction.
o Endentate concerning at least 2 missing teeth in the region requiring reconstruction.
o Absence of clinical signs of infection in the region requiring reconstruction.
o Patients presenting with good dental hygiene (subjective criteria)
o Patients not presenting with any major oral pathologies.
o Dental crest size less than 5 mm.
General criteria:
o Adult patients over 18 and under 80 years of age.
o 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).
o Patients with the capacity to understand medical information and give their informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Local criteria:
o Patients presenting with clinical or radiological signs of bone infection (acute or chronic
osteomyelitis).
o Residual dentition close to the area requiring reconstruction with untreated endodontic disorder
(apical granuloma or apical cyst).
o Untreated oral infection (cellulitis, periodontitis).
o Patients with poor hygiene (subjective criteria).
o Surgical procedure undertaken in the area requiring reconstruction less than 6 months prior to
the bone graft.
o History of malignant tumors of the upper airways / digestive tract or of the jaw.
o History of or scheduled cervico-facial radiation therapy.
General criteria :
o the patient suffer from any serious coagulation disorders that could require substitution therapy
o the patient is receiving VKA therapy, which should be adjusted if necessary so that the INR does
not exceed 2.5
o 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
o the patient has received localized iliac crest radiotherapy contraindicating withdrawal from the
irradiated site
o the patient has major skin lesions or diseases.
o 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.
o Pregnant or breastfeeding women or women not using effective contraception if they are of
childbearing age.
o Patients presenting with cancerous disorders (carcinoma, sarcoma, leukemia, lymphoma) or
psychiatric disorders or with uncontrolled systemic diseases (diabetes, hypertension), or chronic
renal disease.
o Severe bruxism.
o History of chemotherapy.
o Smoking or alcohol addiction. Occasional consumption of alcohol and/or smoking will be noted
in the case report form.
o Patients with an ASA score of 0 or 1, incapable of tolerating general anesthesia.
o Immunosuppression
o Body mass index outside the normal range, particularly > 30 because of increased surgical risk
at the time of BM harvesting from the iliac crest.
o 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.).
o HIV, HTLV and/or syphilis seropositivity.
o Hepatitis B or C infection.
o Active autoimmune disease.
o History of immunosuppressant treatment or bone marrow treatment.
o Administration of treatment interfering with bone metabolism.
o Patients requiring antibiotic prophylaxis before any dental procedure
o Concomitant treatments: history of treatment or current treatment with bisphosphonates, long
term corticosteroid treatment.
o Minor(s) or persons of full age under tutorship.
Tests are left to the discretion of the physician

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified