Transcutaneous Electrical Nerve Stimulation (TENS) as a Non-invasive Non-pharmacological Method to Alleviate Discomfort During Orthodontic Tooth Movement - An In-vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to learn if Transcutaneous Electric Nerve Stimulation (TENS) device works to reduce discomfort during orthodontic treatment, by using orthodontic separators to mimic the discomfort of braces.
The main questions it aims to answer are:
- Does TENS device lower the participants level of discomfort?
- Will TENS device be effective with orthodontic tooth movement?
Researchers will place the separators on different sides of upper and lower first molars. TENS device will be applied on each participant on one of both teeth (according to their group), so that the results can be compared within the same person. Participants will:
- Visit the clinic after 12 or 24 hours (depends on their group)
- Stay on dental chair while TENS device is applied.
- Rate the discomfort level on VAS scale before and after TENS device application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants don't know which group they are assigned to.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full permanent dentition excluding third molars.
- •Sound not carious nor endodontic treated contralateral first molars.
- •Interproximal contact mesial and distal to first molar present on both upper and lower molars.
排除标准
- •Dental pain.
- •Heart arrhythmias.
- •History of seizures.
- •Taking any pain medication during the test period.
- •Missing tooth excluding third molars.
- •Endodontic treated or carious first molar.
- •Spacing mesial or distal to the first molar.
研究组 & 干预措施
12 Hours Maxilla
Participants recalled after 12 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).
干预措施: TENS Device (Other)
12 Hours Mandible
Participants recalled after 12 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).
干预措施: TENS Device (Other)
24 Hours Maxilla
Participants recalled after 24 hours of separators application and TENS device applied on maxillary arch (mandibular arch is considered as control).
干预措施: TENS Device (Other)
24 Hours Mandible
Participants recalled after 24 hours of separators application and TENS device applied on mandibular arch (maxillary arch is considered as control).
干预措施: TENS Device (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: From orthodontic separators application to 12 or 24 hours depends on the participant group.
To rate the level of discomfort pre and post TENS device application, where 0 is equivalent to no discomfort and 10 indicates most discomfort possible.
Visual Analogue Scale
时间窗: From orthodontic separators application to 12 or 24 hours depends on the participant group.
To rate the level of discomfort pre and post TENS device application, where 0 is equivalent to no discomfort and 10 indicates most discomfort possible (the more reduction of the level of discomfort the better for the study results).
次要结局
未报告次要终点