“COMPARATIVE EVALUATION OF LOW LEVEL LASER THERAPY AND MINI IMPLANT FACILITATED MICRO-OSTEOPERFORATIONS ON THE RATE OF TOOTH MOVEMENT - A PROSPECTIVE CLINICAL STUDYâ€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome to compare the tooth movement with low level laser therapy and modified micro osteoperforation in two different groups.
研究概览
简要总结
This is an prospective clinical study to evaluate and compare the effect of modified micro-osteoperforations with low level laser therapy on the rate of tooth movement. The study will be conducted at Teerthankar Mahaveer Dental College And Research Centre on 20 patients age 18- 30 years having Class II division I or Bimaxillary Protrusion malocclusion pattern from Dept. of Orthodontics and Dentofacial Orthopaedics. The study will be a comparative clinical trial conducted from the beginning of 2nd Phase (space closure phase) of fixed orthodontic treatment, for duration of 6 weeks
To check movement of tooth digital scan of the patient will be done with the help of intra oral scanner before and after canine retraction, the patients will be equally and randomly divided into 2 groups: Group1 in which LLT will be randomly assigned to one side of the maxillary arch (experimental side), and a Group 2 in which MOPs will be randomly assigned to one side of the maxillary arch (experimental side). Randomization will be performed with coin tosses to prevent selection bias. The sides contralateral to the procedures will serve as the controls in both groups.
Secondary outcome to assess the pain and discomfort level in the patients during the treatment with Micro-osteoperforation using a numerical rating scale and to check analgesic effect of LLLT during orthodontic tooth movement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with Angle’s Class II Div1 malocclusion (indicated for bilateral maxillary first premolar extraction) or Bimaxillary protrusion (indicated for all first premolar extraction).
- •2.All subjects with age group of 18 – 30 years.
- •3.All subjects undergoing treatment with Pre-adjusted Edgewise Appliance (PEA) with 0.022 MBT prescriptions.
- •4.Subjects who have completed the leveling and alignment (1st Phase).
排除标准
- •1.Previous history of orthodontic treatment.
- •2.Presence of craniofacial anomalies.
- •3.Presence of any signs and symptoms of gingival and periodontal diseases.
- •4.Long-term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
- •5.Poor oral hygiene for more than 2 visits.
- •6.Severe skeletal Class II malocclusion, overjet more than 10 mm.
- •7.Systemic diseases.
- •8.Evidence of bone loss.
- •9.Past periodontal disease.
- •11.Gingivitis and caries.
结局指标
主要结局
The primary outcome to compare the tooth movement with low level laser therapy and modified micro osteoperforation in two different groups.
时间窗: Subjects will be evaluated at baseline, 3 weeks and 6 weeks later on his or her opd visits.
次要结局
- secondary outcome is to acess discomfort level in the patients during the treatment with Micro- osteoperforation using a numerical rating scale and to check analgesic effect of Low level laser therapy during orthodontic tooth movement.(Subjects will be evaluated at baseline, 3 weeks and 6 weeks later on his or her opd visits.)