Comparison of the effect of sonic and oscillating tooth brushes on orthodontic tooth movement during en-masse retraction-A randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To measure the amount of tooth retraction
研究概览
简要总结
Aim of the study is to evaluate the effect of sonic and oscillating tooth brushes on orthodontic tooth movement during en-masse retraction.
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To evaluate the effect of sonic toothbrushes on orthodontic tooth movement during en-masse retraction compared to control group.
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To evaluate the effect of oscillating toothbrushes on orthodontic tooth movement during en-masse retraction compared to control group.
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To evaluate the effect of vibration on pain perception using sonic and oscillating tooth brushes compared to control group.
PROCEDURE
Participants of age 18-25 years with bimaxillary protrusion or Angle’s class II division 1 malocclusion with mild crowding 1-3 mm assessed by little’s irregularity index requiring extraction of upper 1st premolars will be selected from the outpatient department of Orthodontics. Written informed consent will be taken. Patients will be selected and randomly assigned into test and control sites. The trial starts after levelling and alignment(TO). Premolars will be extracted and en-masse retraction of the anterior teeth will be initiated. The trial ends at the end of 6 months. Group 1,subjects will be asked to apply vibrations using sonic toothbrush vibrating at 316Hz for 10 min immediately after arch wire placement and twice daily in the morning and night for 4 months. Group 2, Subjects will be asked to apply vibrations using oscillating toothbrush vibrating at 60 Hz for 10 min immediately after arch wire placement and twice daily in the morning and night for 4 months. Group 3 acts as control group. No intervention in the control group. Subjects in test groups will be reminded to use electric toothbrushes twice daily(20min/day) by sending an alarm using To Do Reminder mobile app. Impressions will be taken using alginate, and models will be poured. Measurements will be made using digital callipers with a sharpened fine edge of accuracy to 0.01mm. Each of the participant will be provided with a specifically designed visual analogue scale (VAS) 52 diary (Appendix) and are requested to note the intensity of perceived pain (using the terms ’0’ - no pain to ’10’- the highest pain) on a 10cm visual analogue scale in the first 6 weeks at various points of time such as t1-2 hours after arch wire placement; 12-6 hours; t3 - at bed time; t4 -24 hours; t5 - 2 days; t6 - 3 days; t7 - 7 days. The amount of tooth retraction will be measured at 4th(T1),8 th(T2),12th(T3),16th(T4), 20th(T5),24th(T6) weeks when the patient is scheduled for routine check up visits. The radiographs are taken at T0 and T6 to evaluate the inclination of canines and molars. Data will be collected for intergroup and intragroup comparison by statistical analysis.
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 and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Physically and mentally healthy individuals of both genders in the age group of 18-25 years 2.Class I malocclusion with bimaxillary protrusion 3.Class II division 1 malocclusion 4.crowding 1-3mm assessed by littles index 5.space requirement showing all four premolar extractions 6.No history of orthodontic treatment 7.Healthy teeth without any caries or active lesions 8.Patients with full permanent dentition 9.Patients without any habit of alcohol intake and smoking.
排除标准
- •1.Evidence of bone loss or periodontal problems 2.Patients with systemic diseases 3.Patients with pacemakers and any other medical devices that interfere with vibration 4.Patients taking medication that can interfere with orthodontic tooth movement 5.Extractions other than 1st premolar extraction in the upper arch 6.Crowding greater than 3mm 7.Pregnant patients 8.Patients with removable appliances and additional appliances that could be unpredictable pain sources such as headgear and miniscrew 9.Patients who has undergone orthognathic surgery 10.Missing teeth except for third molars treatment with extractions (impacted or unerupted permanent teeth).
结局指标
主要结局
To measure the amount of tooth retraction
时间窗: To measure the amount of tooth retraction at 4th,8th,12th,16th,20th and 24th weeks
次要结局
- Intensity of perceived pain will be measured using visual aalogue scale(t1-2 hours after arch wire placement,t2-6hours,t3-at bed time,t4-24hours,t5-2days,t6-3days,t7-7days)
研究者
BESTA VIJAYA LAKSHMI
NARAYANA DENTAL COLLEGE AND HOSPITAL