Clinical evaluation of the alignment efficacy and pain with CuNiTi and Multistranded SS arch wires during initial orthodontic treatment- Randomised clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assessment of Alleviation of Crowding, intercanine width, interpremolar width, inter molar width, littles irregularity score.
研究概览
简要总结
This was a randomized controlled trial having a parallel-arm design with an identical allocation ratio of one to one. All the patients were bonded with MBT prescription 0.022x0.028 inch slot (3M
unitek) brackets. The patients in group A and group B receives 0.016-inch Cu NiTi and 0.0175-inch Multi-stranded Stainless steel respectively at the initial appointment which is denoted as T0. The Little’s irregularity index was employed to assess the anterior crowding, Intercanine width, Interpremolar width and Intermolar width. at pre- treatment (T 1 ) and post-treatment (T 2 ) stage after 6 weeks. Each of the recruited subject in the study were provided with a specifically designed Visual analogue scale (VAS) diary. They were requested to note the intensity of perceived pain (using the terms ‘0’- no pain to ‘100’- the highest pain) on a 10 cm VAS in the first month, at various time periods such as 4hours, 24hours, 3days, 1week, 1 month and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 20.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of normal health with physical and mental fitness.
- •2.Age between 12 to 20 years 3.Patients with symmetrical jaws as assessed on orthopantamogram (OPG).
- •4.Confirmation that all permanent teeth have fully erupted from the second molar to second molar (with no extraction in the mandibular arch).
- •5.Mandibular anterior dental crowding (Little’s irregularity index (Little 1975) greater than 6mm) 6.No spaces in the mandibular arch.
- •7.(Patients with class I molar and skeletal relationship) 8.Patients with normal vertical growth pattern.
- •9.Normal Systemic and periodontal health.
排除标准
- •1.Patients with systemic diseases or any drug therapy that interferes with orthodontic tooth movement.
- •2.Patients with any abnormal vertical growth pattern and horizontal growth pattern.
- •3.Patients with blocked out tooth in the lower anteriors.
- •4.Missing teeth except for third molars treatment with extractions (impacted or unerupted permanent teeth) 5.History of previous orthodontic treatment with either intra-oral or extra-oral appliances (including removable appliances, rapid palatal expansion appliances, or headgear) and functional appliances.
- •6.Craniofacial syndrome or Skeletal asymmetry (with cleft lip and palate, anomalies, and syndrome).
结局指标
主要结局
Assessment of Alleviation of Crowding, intercanine width, interpremolar width, inter molar width, littles irregularity score.
时间窗: preT0 (at the time of wire placement) and post treatment T6 (after 6 weeks)
次要结局
- Assessment of pain perception(At 4hours (T1), 24hours (T2). 3days (T3), 1week (T4), 1 month (T5) and 6 weeks (T6))