NL-OMON24676招募中不适用
A Single-Center, Single-Cohort Study of FF-37101 for Bone Formation in the Maxillomandibular Region
Fujifilm Manufacturing Europe BV0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization.
- •18 year or older at time of informed consent.
- •Have 1 tooth (front, pre-molar or molar) of poor prognosis diagnosed for tooth extraction.
- •Have 1 or more healthy tooth/teeth immediately adjacent to the tooth that is to be extracted.
- •Have a type I or type II socket of the buccal alveolar bone of the tooth to be extracted.
- •Absence of pockets of 5mm or more in the full dentition, with exception of the pocket of the tooth to be extracted.
- •Able to return for follow-up visits, as defined in this clinical investigation plan, after tooth extraction.
- •Scheduled to have an implant placed 6 months after tooth extraction and FF-37101 implantation.
排除标准
- •Signs of active inflammation, i.e. presence of inflammatory fluid during tooth extraction.
- •Active generalized periodontal disease; evident periapical radiolucencies or abscesses; autoimmune disorders; taking or having a history of bisphosphonate medications or Denosumab (history of MRONJ (medication-related osteonecrosis of the jaw)/BRONJ (bisphosphonate-related osteonecrosis of the jaw)); congenital or metabolic bone disorders; or uncontrolled diabetes.
- •Full coverage restoration or large metallic restoration work including dental implant completed on any tooth adjacent to the tooth to be extracted in this clinical investigation.
- •Current or former smoker or user of chewing tobacco or nicotine-containing products. Former smokers or users are defined as subjects who smoked 10 cigarettes or more (or an equivalent amount of other tobacco products) per day in the 5 years prior to screening.
- •Females who are pregnant, breastfeeding, or are planning to conceive during their enrollment in the clinical investigation.
- •History of any clinically significant mental and/or psychological, or other major disease, as determined by the investigator that would prevent dental treatment.
- •Inability to effectively communicate with study staff during the clinical investigation.
- •History of any severe allergic or anaphylactic reactions to collagen or gelatin, or current sensitivity to collagen or gelatin.
- •Unwillingness or inability to comply with the requirements of this clinical investigation plan.
- •Previous head and neck radiation- or chemo-therapy.
- •Other reasons that, in the opinion of the investigator, will make the subject unsuitable for enrollment.
研究者
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