Comparison of effectiveness of one time versus two time piezoperforation on the rate of orthodontic tooth movement:A three arm parallel study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- amount of tooth retraction
研究概览
简要总结
The aim of this study is to assess and compare the effect of one time versus two time Piezoperforation in orthodontic tooth movement during enmasse retraction in maxilla using piezotome
To assess the orthodontic tooth movement using one time piezoperforation compared to control
To assess the orthodontic tooth movement in Two time Piezoperforations compared to control.
To compare the orthodontic tooth movement using one time versus two time piezoperforation compared to control.
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 by block randomisation . Levelling and alignment will be done. Premolars will be extracted and the trial starts after one month of extraction T0 and en-masse retraction of the anterior teeth will be initiated. The trial ends at the end of 3 months T4
Piezoperforations will be performed using piezotome , under local infiltration of 2ml Lignocaine . Three small perforations with each perforation of 1.5 mm diameter and 4 mm depth were done bilaterally in the extraction space distally to the canine.The perforations were spaced 3 mm apart vertically , which was measured using William’s periodontal probe clinically. Bleeding is controlled, and canine retraction will be started immediately on both sides using Nickel Titanium closed coil springs delivering 150 gm force. The second MOP will be performed only in the Group III experimental group 6 weeks after the first MOP.
Group I -No intervention in the Control group
Group II-One time intervention of Piezoperforation will be given one month after extraction of premolars
Group III-Two time interventions of piezo perforations will be given. The first intervention will be given after 1 month of extraction of premolars, and the second intervention will be given at the end of the 6th week.
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 study subject will be provided with a specifically designed visual analogue scale VAS diary 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 at various points of time such as t1-2 hrs after piezoperforation,t2-6 hrs , t3 –12 hrs, t4 -24 hrs,t5 – 2 days
The amount of tooth retraction will be measured at the 2nd T1, 4th T2, 8th T3, and 12th T4 weeks when the patient is scheduled for routine check-up visits.
The radiographs will be taken at T0, T2, T4 to evaluate the inclination of canines and molars.
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 little’s index space requirement showing all four premolar extractions 5.No history of orthodontic treatment 6.Healthy teeth without any active lesions 7.Patients with full permanent dentition 8.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 ,bleeding diathesis 3.Patients taking medication that can interfere with orthodontic tooth movement 4.Extractions other than 1st premolar extraction in the upper arch 5.Crowding greater than 3mm 6.Pregnant patients 7.Patients with removable appliances, additional appliances that could be unpredictable pain sources such as headgear and miniscrew 8.Patients who has undergone orthognathic surgery 9.Missing teeth except for third molars treatment with extractions (impacted or unerupted permanent teeth).
结局指标
主要结局
amount of tooth retraction
时间窗: The amount of tooth retraction will be measured at | the 2nd(T1), 4th (T2), 8th (T3), and 12th (T4) weeks
次要结局
- Intensity of perceived pain measured on a 10cm visual analogue scale(t1-2 hrs after piezoperforation, t2-6 hrs , t3 –12 hrs, t4 -24 hrs, t5 – 2 days)
研究者
Eranti Saimanogna
Narayana Dental College and Hospital