A First-in-Human Study of a Novel 3rd Molar Tooth Bud Ablation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Tooth Structure Development Assessment
研究概览
简要总结
The goal of this single-arm prospective, non-randomized study is to demonstrate microwave ablation and agenesis of 3rd molar tooth buds using the Zero3 System in participants that have 3rd molar tooth bud(s) without the formation of enamel (calcification). Typically ages 8 to 12 years. The main question it aims to answer is:
• Effectiveness of 3rd Molar ablation and agenesis
Participants will
- Have CBCT and IOS scans to determine the presence of 3rd molar tooth buds without enamel formation (calcification)
- If indicated, have the Zero3 procedure to ablate the 3rd molar tooth buds
- Visit the dentist at 7, 30, and 90 days to observe 3rd molar agenesis. Participants will exit the study at 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 8 and 12 years of age
- •Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud
排除标准
- •Subject use of articaine is contraindicated (known hypersensitive to products containing sulfites).
- •Subject has any condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the subject.-
研究组 & 干预措施
Zero3 Procedure
干预措施: Zero3 System (Device)
结局指标
主要结局
Tooth Structure Development Assessment
时间窗: 12 weeks
Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Tooth Structure Development and Bony Crypt In Growth using the following scale. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. Success is defined as a score of "0" or "1" on Tooth Structure Development scale at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually.
Bony Crypt Growth Assessment
时间窗: 12 weeks
Efficacy assessment will be performed based on periapical X-rays from Follow-up Visit 3 (12-week post treatment). Effectiveness Assessment will consist of evaluation of Bony Crypt In Growth using the following scales. Tooth Structure Development Assessment Scale for 3rd Molar: "0" = No radiographic evidence. "1" = Minimal or trace level of detectable radiographic evidence of mineralized tooth structure formation. "2" = Moderate or intermediate level of detectable radiographic evidence of mineralized tooth structure formation with crown formation to be less than 50% complete. "3" = Advanced level of detectable radiographic evidence of mineralized tooth structure formation with enamel formation estimated to be 50% or more complete. N/I = Not Interpretable. N/A = Not Applicable. Success is defined as a score of "0" or "1" on Bony Crypt Growth Assessment scales at Follow-up Visit 3 (12-week post treatment). Each treated tooth bud is evaluated individually.
Incidence of wound healing and adverse events
时间窗: 90 Days
* Incidence of puncture site wound healing complete post procedure at day 1, day 7, day 30, day 90 as visually evaluated by treating dentist. Success is defined as greater than 90% healing of the puncture site by day 90 post-procedure by visual evaluation by the Investigator. * Incidence of serious adverse events related to the Zero3 procedure at day 1, day 7, day 30, day 90. Success is defined as an incidence of less 5%. A Medical Monitor will review all adverse events and classify each as serious or not serious. * Pain will be assessed using the Faces Pain Scale- Revised, with mean pain scale determined for all Participants.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](12 weeks)
- Incidence of 3rd molar tooth bud agenesis(90 days)