combined effect of photobiomodulation using low energy laser therapy and micro-osteoperforation on the rate of orthodontic tooth movement: a split mouth randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To measure the effect micro-osteoperfoation and low levell laser therapy on the rate of tooth movement
研究概览
简要总结
The aim of the present study is to evaluate the combined effect of Micro-osteoperforation (MOP) combined with Low level laser therapy over 9 weeks period (63 days) on the rate of orthodontic tooth movement. This is a single center, split mouth, parallel-arm, randomized controlled clinical trial performed with 1:1 allocation ratio. Primary goal will be to evaluate the effect of modified micro-osteoperforations combined with Low Level Laser Therapy (LLLT) on the rate of orthodontic tooth movement. Secondary goal will be to assess the pain and discomfort level in the patients during the treatment using a visual analogue scale.
The null hypothesis will be that combined effect of MOP + LLLT does not accelerate the rate of tooth movement compared to their matched control. MOP and LLLT will be given on one side and gingival perforations will be done on the other side of the split mouth model. This will be done in the extraction space immediately after commencement of canine retraction and the measurement will be done on dental casts using digital vernier callipers.
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 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Angle’s Class II Div1 malocclusion (indicated for bilateral maxillary first premolar extraction) or Class I Bimaxillary protrusion (indicated all first premolar extraction)
- •All subjects with age group of 18 – 30 years.
- •All subjects undergoing treatment with Pre-adjusted Edgewise Appliance (PEA) with 0.022 MBT prescriptions.
- •Subjects who have completed the leveling and alignment (1 st Phase).
- •No systemic disease.
- •No radiographic evidence of bone loss.
- •No history of periodontal disease.
- •No smoking.
排除标准
- •Previous history of orthodontic treatment
- •Presence of craniofacial anomalies
- •Presence of any signs and symptoms of gingival and periodontal diseases
- •Long-term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
- •Poor oral hygiene for more than 2 visits
- •Systemic diseases
- •Evidence of bone loss
- •Past periodontal disease
- •Gingivitis and caries.
结局指标
主要结局
To measure the effect micro-osteoperfoation and low levell laser therapy on the rate of tooth movement
时间窗: at baseline, 21st day, 42nd day, 63rd day
次要结局
- To assess the pain perception related to procedure.(to assess their)
研究者
Abhay Kumar Jain
Rajendra Institute of Medical Sciences (RIMS), RANCHI, JHARKHAND