NL-OMON55475招募中不适用
A Single-Center, Single-Cohort Study of FF-37101 for Bone Formation in the Maxillomandibular Region - A study with a bonefiller to stimulate bone formation in the jaw
FUJIFILM Manufacturing Europe BV0 个研究点目标入组 28 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
- 28
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
- •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.
- •- Metal root pin or 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 the 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
研究者
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