跳至主要内容
临床试验/NCT06548685
NCT06548685尚未招募不适用

Vegetable Ivory Bone Material Study to Evaluate Whether a Biobased Natural Vegetable Ivory Formulation Can Produce Similar or Better Results Compared to Current Standard Bone Healing Treatments

Mark Stanczyk0 个研究点目标入组 5 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Mark Stanczyk
入组人数
5
主要终点
Number of participants with completely healed bone graft surgical site

研究概览

简要总结

The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.

详细描述

The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.

Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have parallel sites from which teeth have been extracted

排除标准

  • They are not a candidate for bone grafting or a dental implant

结局指标

主要结局

Number of participants with completely healed bone graft surgical site

时间窗: Six Months

The number of participants who have bone volumes that match or exceed the control sites.

次要结局

未报告次要终点

研究者

发起方
Mark Stanczyk
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Mark Stanczyk

VP

Dentivia, LLC

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