Evaluation of Low-Level-LASER Therapy (LLLT) Effect on Accelerating Orthodontic Tooth Movement For Crowded Upper Incisors Leveling and Alignment in Lingual Orthodontic Patients: A Randomized Clinical Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Tooth Alignment at one month
研究概览
简要总结
We will treat patients with class I malocclusion who have moderate crowding (4-6 mm) according to Little's irregularity index and asses the efficacy of low level laser therapy in accelerating orthodontic tooth movement .
There is two groups :
- treated with Low level laser therapy (LLLT)
- treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed.
Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .
详细描述
The time of orthodontic treatment is considered to be one of the most concerns for patients. The study will investigate the effect of low level laser therapy on the speed of orthodontic tooth movement during the correction of moderately crowded anterior upper teeth using lingual orthodontic appliance.
The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention.
Low level laser with a wave length of 830 nm, output of 150 mW, energy of 2 J per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth.
Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I malocclusion with mild to moderate crowding
- •Old between 17-27 years
- •Good oral hygiene
- •Patients should be fit and well
- •4-6 mm crowding in upper incisors according to Little's index
- •Enough clinical crowns length
排除标准
- •Patients who had an old orthodontic treatment
- •People who have any drug or disease affect orthodontic movement
- •Any contraindication for orthodontic treatment
研究组 & 干预措施
Lingual orthodontics
Patients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way.
干预措施: low level laser therapy (Radiation)
Lingual orthodontics
Patients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way.
干预措施: Lingual Orthodontics (Device)
Low level laser therapy
Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.
干预措施: low level laser therapy (Radiation)
结局指标
主要结局
Change in Tooth Alignment at one month
时间窗: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.
Little's Index of Irregularity will be measured at 30 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Duration of tooth alignment
时间窗: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
Days required to complete tooth alignment will be counted.
Change in Tooth Alignment at the end of Alignment Stage
时间窗: T1: one day before the beginning of treatment; T2: when alignment of teeth is complete and this is expected to occur within 90 - 120 days
Little's Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Change in Tooth Alignment at two months
时间窗: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.
Little's Index of Irregularity will be measured at 60 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
次要结局
- Change in the levels of pain and discomfort(T1: 10 minutes following the insertion of the first wire in the beginning of treatment; T2: at 24 hours post-commencement; T3: at 48 hours; T4: at 72 hours following the placement of primary archwire)
- Change in Patients' Acceptance((1) one day following the beginning of the treatment, (2) after one week of the beginning of treatment, (3) after 4 weeks, (5) at the end the alignment stage which is expected to occur within 3 to 4 months)