Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- temporomandibular pain
研究概览
简要总结
This observer-blind crossover intervention study aims to determine the most effective type of device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types of devices: standard, prefabricated and manufactured in the dental laboratory.
Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge will use the three devices at a random sequence during the twelve treatment sessions, so each device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.
详细描述
Treatment with electroconvulsive therapy will involve the application of 12 m-ECT sessions at the rate of two sessions for six weeks according to the protocol established in the ECT Unit of the Department of Psychiatry at the University Hospital of Bellvitge.
Two devices, SB and CA, will be prepared for each patient and placed in mouth before anesthesia by one operator. This operator will assign a randomized sequence of use of the three devices (SB, CA or SM). Device SM will be the sole protector that will be placed after the anesthesia by nurse.
The outcome assessor will the scans pre- and post-session m-ECT and collect data, accede the surgery room before the session with the patient conscious and perform the exploration. This outcome assessor will leave the operating room during the procedure for the application of m-ECT an come back an hour later for the post-examination session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should have an intellectual level that allows a proper communication and must agree to cooperate in all tests and exams required by the study protocol.
- •Obtaining written informed consent for participating in the project (model consent form)
- •The patient must have enough teeth in the upper arch or being a carrier of a stable removable prosthesis.
排除标准
- •Being in a maintenance ECT program.
- •Receiving ECT during the six months prior to the index episode.
- •Pregnancy and lactation.
结局指标
主要结局
temporomandibular pain
时间窗: through study completion, an average of six weeks
Continuous quantitative variable assessed by visual analogue scale (VAS) of 100 mm in length, marking the end as no pain (source) or the worst pain imaginable (final)
次要结局
- Dental fractures(through study completion, an average of six weeks)
- Dental mobility assessed by Periotest®(through study completion, an average of six weeks)
- Oral soft tissues injuries(through study completion, an average of six weeks)
研究者
Eva Willaert Jiménez-Pajarero
DDS, PhD
University of Barcelona