A Comparison of Efficiency of Transcutaneous Electric Nerve Stimulation and Low-Intensity Pulsed Ultrasound for Reducing Pain associated with orthodontic tooth movement : A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess the pain level associated with orthodontic tooth movement after Separator placement
研究概览
简要总结
This will be a in-vivo study. 66 patients undergoing orthodontic treatment will be selected for the study. The study protocol will be verbally explained and a consent form will obtained from the patients and only those willing are going to include in the study. For all subjects elastic separators (Ortho Organizer Inc.) will be placed mesially and distally to both maxillary first molar by using elastomeric separating pliers. The TENS device used in this study is designed by UltraCare PRO (Zealmax Innovations Pvt. Ltd, Gujarat, India). It is a dual-channel rechargeable TENS unit made for pain relief and has a compact, portable design made for easy operation with four reusable self-adhesive electrode pads to be used. Patient will further informed about a pain-relieving gadget that delivered a modest electric current and also the stimulus might be anything from sub-sensory to a little tingle.Immediately after placement of separator a self adhesive electrode pads will be placed on the subjects zygomatic arch. TENS unit will be set to deliver a current frequency of 0.5 Hz with an intensity of 500 mA. The duration of each Session will be 20 minutes. The same procedure will repeat after 24 hours.
Low-Intensity Pulsed Ultrasound(Medgears Digital Unit Ultrasound Physiotherapy Machine-Tapsi CYCLOPS 1) will be used on other group of patients. First, a small amount of gel applies to the outer surface of facial skin than moves the Ultrasound Machine Head in small circular direction over area of zygomatic arch for 7 min. The output frequency of the device will be 1 MHz, The maximum output power will be 3 W/cm2 in the pulse mode. The same procedure will get repeat after 24 hours.
•Following the separator placement and giving TENS therapy or Ultra sound therapy , each subject will get VAS scoring slips(Figure-4) and instructed to evaluate their pain every 12 hours by marking the spot on the line they believed to best represent the pain they will experiencing at that time for 4 days.
The VAS Scale is 10-cm line labelled at each end by descriptor such as ‘no pain’ and ‘worst pain’.
Subjects will be also instructed to make each evaluation independently from the previous ones by not consulting the previous VAS ratings.
Patient will be asked to set 12 hours alarm for reminder and after filling form every 12 hours send the confirmation message on WhatsApp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients receiving fixed orthodontic treatment.
- •Patients in age group of 18-35 years Absence of spacing, presence of tight contacts between the permanent first molar and adjacent teeth.
- •Intake of no systemic analgesics.
- •Presence of antagonistic tooth.
- •Absence of posterior open bite.
- •Good oral hygiene and healthy periodontium.
排除标准
- •Patients who do not give consent for the study.
- •Patients under pain or anxiety medications.
- •Patients with compromised periodontium.
- •Patients with Migraine Patients whose pain will not relieved after 2 cycle of TENS and US therapy.
结局指标
主要结局
To assess the pain level associated with orthodontic tooth movement after Separator placement
时间窗: 4 Days
次要结局
- To assess the pain level associated with orthodontic tooth movement after giving Transcutaneous Electric Nerve Stimulation or Low-Intensity Pulsed Ultrasound Therapy for consecutive 2 days after Separator placement(4 Days)
研究者
Dr Ankita Mandavia
Manubhai Patel Dental College and Dental Hospital and SSR General Hospital Gujarat