ACTRN12622001002774尚未招募未知
Assessment of 3D-printed patient specific scaffolds for vertical mandibular bone regeneration following ablative and reconstructive surgery
Metro North Health0 个研究点目标入组 6 人开始时间: 2022年7月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Patients under surveillance after head and neck ablation and reconstruction – within 6-
- •24 months post-surgery
- •Patients interested in oral/dental rehabilitation
- •Significant vertical bony height discrepancy (Minimum of 6mm height discrepancy
- •between native mandible and level of resected/neomandible)
- •Not previously irradiated
- •Adequate soft tissue to cover scaffold
- •Women of reproductive age who are currently on one of the following methods of contraception:
- •-Barrier method of contraception: condoms (male or female) with or without
- •spermicidal agent, diaphragm, or cervical cap with spermicide
- •-Intrauterine device
- •-Hormone-based contraceptive
- •Participant willing and able to comply with the study requirements
- •Participant or guardian capable of providing valid informed consent
排除标准
- •Irradiated patients
- •Current smokers
- •Poorly controlled diabetics (HbA1c of >7%)
- •Patient or guardian unwilling or unable to provide fully informed consent.
- •Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.
- •Known severe concurrent or inter-current illness including: cardiovascular, respiratory, or immunological illness, psychiatric disorders, or alcohol or chemical dependence, or possible allergies (including allergy to PCL) that, at the discretion of the clinical leads Dr Omar Breik and A/Prof Martin Batstone, would compromise the participant safety or compliance or interfere with interpretation of study results.
- •Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the reconstruction surgery.
- •Women of childbearing potential without an appropriate contraceptive method.
- •Life expectancy less than 24 months.
- •Unable or unwilling to comply with the study requirements.
- •Patients unlikely to proceed to dental rehabilitation (These are usually patient who are not interested in undergoing multiple procedures for rehabilitation, patients who have multiple failed appointments, poor oral hygiene, or advanced dental disease affecting their remaining teeth such as periodontitis or dental caries.)
- •Unreliable follow up record (Multiple failed attendances for their regular follow up appointments)
研究者
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