Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material Applied by Vertical Condensation Obturation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Percent Reduction in Apical Radio-lucency
研究概览
简要总结
Non-surgical root canal therapy (RCT) represents a standard of treatment that addresses infected pulp tissue in teeth and protects against future infection while preserving the tooth for the patient for mainly cosmetic purposes. RCT is offered as the better cosmetic, cheaper, and less time intensive treatment option for a patient compared to those of dental implantation. Dental implantation is the alternative to RCT, and they are both originally offered at the time of the initial consultation. RCT involves non-surgically removing dental pulp comprising blood vessels and nerve tissue, decontaminating residually infected tissue, and using a filler material to replace the non-surgically created space where the pulp was removed. Currently, standard of care treatment for RCT utilizes gutta-percha as the root canal filling material. Our research group has previously demonstrated NDGP's improvement in tensile strength compared to those of gutta-percha. This research studies a new type of filler, gutta-percha modified by the addition of nanodiamond material (NDGP). This is an equivalence study of NDGP and standard gutta-percha administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older when patient is referred to UCLA endodontics department for root canal therapy
- •Patient referral to UCLA endodontics department for root canal therapy
排除标准
- •preoperative periodontal disease
- •prior non-surgical and surgical endodontic treatment
- •currently taking medications used to treat osteoporosis or any form of IV biphosphonates
- •allergic to dental materials
- •dental phobia
- •MD consult/medically compromised/prophylaxis needed
- •developmental/congenital disorders
- •craniofacial disorder/syndromic cases
- •low pain tolerance ascertained from past dental experience
- •current moderate to severe periodontitis
- •previous RCT/initiated pulp therapy
- •previous apical surgery
- •previous surgical root canal procedure
- •with psychiatric and/or mental health history
- •poor oral hygiene
- •poor diet
- •illicit and/or recreational drug use
- •complicated dental history
结局指标
主要结局
Percent Reduction in Apical Radio-lucency
时间窗: 6 months
A radiograph of the treated tooth is made after 6 months post treatment, which will be compared with the radiograph of the treated tooth taken immediately after the RCT procedure. Clinical examination is performed at 6 months after the operation. The greatest diameters (mm) of the radio-lucency were recorded.
Number of Participants With Absence of Apical Periodontitis
时间窗: 1 year
Apical periodontitis resulting in pain and apical lucency is measured. A radiograph of the treated tooth is made after 1 year post treatment, which will be compared with the radiographs of the treated tooth taken immediately after the RCT procedure and 6 months post treatment. Clinical examination is performed at 1 year after the operation.
次要结局
- Number of Participants With Post-Operative Pain(6 months)
- Number of Participants With Tooth Survival (6 Month)(6 months)
- Number of Participants With Tooth Survival (1 Year)(1 year)
研究者
Eric Sung, DDS
Professor of Clinical Dentistry
University of California, Los Angeles