Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- 72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
研究概览
简要总结
Patients with painful molars will be randomly assigned to 2 different groups: GentleWave and EndoActivator. The root canals will be completed using identical protocols except in the mode of delivery and activation of irrigation (using either the GentleWave or EndoActivator). Postoperative pain and pain pill consumption will be measured for the 4 days following their root canal using a Visual Analog Scale and Pain Pill Log, respectively. The alternative hypothesis is that patients undergoing treatment using the GentleWave will experience less pain postoperatively and will consume fewer pain pills.
A 12-month follow up with exam and radiographs will be completed to evaluate healing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.
排除标准
- •Pregnant women
- •Prisoners
- •Persons unable to adequately provide informed consent
- •Non-restorable teeth
- •Patients unable to sit in the dental chair for 3 hours
- •Patients with compromised cardiac health requiring less than .08mg epinephrine
- •Patients with a pacemaker
- •Patients where Ibuprofen and Acetaminophen are contraindicated
- •Patients unable to swallow pills
- •Patients with pain originating somewhere other than the tooth in question
- •Patients having taken analgesics within previous 6 hours
结局指标
主要结局
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
时间窗: 72 hour post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
时间窗: 96 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
时间窗: 48 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
时间窗: 72 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report
时间窗: 12-month recall
Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters.
24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
时间窗: 24 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
时间窗: 24 hr postoperatively
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
时间窗: 48 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Cone Beam Computed Tomography (CBCT) Healing Assessment
时间窗: 12 month recall
Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op.
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
时间窗: 96 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
次要结局
- Pain Pill Consumption for Patients Seen From 09/2021-06/2021(Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.)
- Pain Pill Consumption for Patients Seen From 07/2021-03/2022(Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.)
研究者
David Bingham, DDS
Endodontic Resident at the Center for Advanced Dental Education
St. Louis University