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临床试验/NCT01212939
NCT01212939终止不适用

Revitalization of Teeth With Necrotic Pulps and Open Apexes Using Platelet-Rich Plasma

Torabinejad, Mahmoud2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
2
主要终点
stop the infection

研究概览

简要总结

When root canals of infected teeth with closed ends are cleaned, disinfected and filled, the results are predictable with excellent outcomes. However, in a tooth with incomplete root development, the end of the root(s) must be closed before filling the root canals. One or two-step artificial barrier using mineral trioxide aggregate (MTA) has been used before filling the root canals of these teeth. Despite the high success of this treatment, this procedure does not result in complete root formation and these teeth are susceptible to root fracture. A number of case reports in scientific journal have shown the possibility for regeneration of nerve within the root canal space and continued root development in teeth with dead nerves and open ends. There is very little information regarding the use of stem cells and growth factors from the blood of patients to regenerate the nerves in these teeth. Platelet rich plasma (PRP) from whole blood has been mentioned in the literature as a potential ideal material for regeneration of nerves in these teeth. The purpose of this study is to investigate the use of PRP to regenerate tooth nerve and close the root ends in teeth with root canal infection and open root ends.

详细描述

Procedures Participants in this study must be in overall good health and not allergic to the materials used during this study treatment. If you agree to participate in this study, you will receive a screening visit to determine whether you will qualify for the study. At that time, your medical history will be reviewed, your blood pressure and pulse will be taken and you will be asked to fill out detailed medical and dental histories. In addition, you will receive an examination of your teeth and gums.

In the first appointment, after anesthetizing you with a local anesthetic similar to Novocain and application of a rubber dam to isolate your tooth, an opening will be made into the root canal(s). The canal(s) will be cleaned and medicated with antibiotics to get rid of the infection and sealed with a temporary filling material. Except for the use of antibiotics the rest of the procedures done in this appointment are similar to what the investigators do for the patients for need root canal treatment.

In the second appointment, after providing anesthesia with Novocain and application of rubber dam again, the temporary filling will be removed and the antibiotic will be removed using sterile water. The canal will be then dried. During this appointment, 20 ml of whole blood will be taken from your arm vein and will be used to prepare concentrated cells for injection into the prepared canal and sealed again with a temporary filling material. This part is different than what the investigators normally do for patients who need root canal treatment. For those patients the investigators fill the canals and seal the opening into the root canals with a permanent filling material.

You will return three to seven days later to the endodontic clinic and at that time, after rubber dam application, the temporary filling material will be removed and the tooth will be double sealed with permanent filling materials. This is an extra step that the investigators normally do not take for patients who need root canal treatment. A dental assistant or a dentist will call you to make an appointment at 3, 6, 12, 18, and 24 months following completion of your root canal treatment to check the vitality of the tooth using an ice stick and closure of the root end. Checking the process of healing in your tooth is similar to what the investigators routinely do for our patients who require root canal treatment.

Risks The study will require drawing blood from your arm. Veins and arteries vary in size from one person to another and from one side of the body to the other. Obtaining a blood sample from some people may be more difficult than from others. Other risks associated with having blood drawn are slight but may include bleeding, fainting or feeling light-headed, hematoma (blood accumulating under the skin), and infection (a slight risk any time the skin is broken). In rare instances, it may cause severe pain of infection. Depending upon the complications, your dentist may decide to remove the PRP completely out of the root canal and the use other procedures to treat your tooth. Should root canal failure occur, further dental treatment will be rendered at no charge to you.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 89 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with necrotic pulp and open apex.

排除标准

  • People with vital pulp and closed apexes

结局指标

主要结局

stop the infection

时间窗: 6 weeks

次要结局

  • Revitalizing the nerve of the tooth(Every 3-6 months for two years)

研究者

发起方
Torabinejad, Mahmoud
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Torabinejad, Mahmoud

Principal Investigator

Loma Linda University

研究点 (2)

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