EUCTR2018-001227-39-DK进行中（未招募）1 期
A 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 autologous bone block grafting. - Maxibone
niversity of Bergen, Faculty of Medicin, Department of Clinical Dentistry0 个研究点目标入组 150 人开始时间: 2019年11月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •Written informed consent
- •? Patient should be able to understand and complete the informed consent
- •? Age 18 years or older
- •? Insufficient bone ridge width (= than 4 mm) and or height at the recipient site for
- •titanium dental implant placement
- •? Patient should be eligible for bone marrow harvest and bone transplant
- •? Healthy oral mucosa, at least 2 mm keratinized mucosa
- •? Female candidates of child bearing potential (WOCBP) -as defined by CTFG 2- must be
- •referred to their physician for a pregnancy test 1,2 before inclusion in the study. In
- •case of a negative preganancy test their physician will be asked to prescribe one of
- •the highly effective birth control methods recommended by CTFG 2 which includes:
- •1. Combined estrogen and progestogen containing contraceptives that are
- •associated with inhibition of ovulation (oral, intravaginal or transdermal).
- •2. Progestogen-only hormonal contraceptives associated with inhibition of
- •ovulation (oral, injectable or implantable).
- •3. Intrauterine devices.
- •4. Intrauterine hormone-releasing system.
- •5. Bilateral tubal occlusion.
- •? The WOCBP candidates will only be included in the study if the pregnency tests are
- •negative. These patients must continue using the contraceptives until the placement
- •of dental implants (5 months after bone augmentation procedure considering that
- •pregnancy is not considered as a contraindication for normal dental implant).
- •? Female candidates that have entered menopause for less than 12 months must also
- •be referred to confirm post-menopausal state by testing the level of follicle
- •stimulating hormone (FSH).
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •General contraindications for dental and/or surgical treatments
- •· Contraindications for both bone marrow harvesting and bone grafts:
- •§ Patients with severe bone marrow diseases such as leukemias, lymphomas, and myelodysplastic syndromes.
- •§ Patients with severe respiratory disease, chronic respiratory failure, medical history of generalized allergic manifestation.
- •§ Patients with a history of severe osteoporosis.
- •§ Patients suffering from any serious coagulation disorders that could require substitution therapy.
- •§ Patients receiving anticouagulant treatment should be adjusted in collaboration with the treating physician.
- •§ Patients with total hip prothesis
- •§ Patients with active infection at the harvest site
- •§ Patients with previous pathology or trauma at the harvest site
- •· 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.
- •· Patients with a history of drug addiction.
- •· Patients with known hypersensitivity against paracetamol, codein or xylocaine.
- •· Thin keratinized mucosa (< 1mm)
- •· Current smokers and those who have quitted smoking in the last 4 weeks (there is evidence that nicotine and cotinine levels disappear after 4 weeks of non-smoking).
- •· Pregnant or lactating women.
- •· Participation in an investigational device, drug or biologics study within the last 24 weeks prior to the study start
研究者
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