EUCTR2012-003139-50-NO进行中（未招募）不适用
International, multicenter phase II uncontrolled prospective clinical trial: Jaw bone reconstruction using a combination of biomaterial and autologous mesenchymal stem cells prior to dental implant placementImBioCeSM: Implant placement after reconstruction with a Biomaterial and mesenchymal stem cell combination - Maxillo 1
niversity of Bergen, Faculty of medicin and dentistry, Dep. of Clinical Dentistry0 个研究点目标入组 15 人开始时间: 2013年8月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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,
- •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
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