EFFECT OF INTRAMUSCULAR ADMINISTRATION OF BOTULINUM TOXIN ON TEMPORALIS AND MASSETER DURING TREATMENT IN SKELETAL DEEP BITE PATIENTS - A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Muscle thickness using ultrasound
研究概览
简要总结
Botulinum toxin is a
Aim: To study the effects of intramuscular administration of botulinum toxin on the acceleration of posterior extrusion in skeletal deep bite correction in adults.
P= Adult skeletal deep bite patients treated orthodontically.
I= Intramuscular masseter administration of Botox for orthodontic deep bite correction
C= Orthodontic deep bite correction with extrusion mechanics.
O= Acceleration of extrusion in orthodontic deep bite correction
Rationale : Botulinum toxin is a known neurotoxin. Low dose administration of Botox can reduce muscle activity. These neuromuscular changes
produced by Botox can be used to prevent post treatment bite deepening in adults with deep bite.
Null hypothesis: Intramuscular administration of botulinum toxin deos not accelerate the deep bite correction in adults with skeletal deep bite.
Alternate hypothesis: Intramuscular administration of botulinum toxin accelerates the deep bite correction in adults with skeletal deep bite.
Research question: Does intramuscular injection of botulinum toxin in masseter aid in acceleration of posterior extrusion in skeletal deep bite patients?
Variables:
primary outcome: LAFH- COGS, Posterior dental heights, Mandibular plane angle, Clinical overbite and
Secondary outcome : muscle activity and muscle thickness
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, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Skeletal deep bite Reduced posterior and anterior facial height.
排除标准
- •Poor periodontal status Blood dyscariasis Retreatment orthodontic patients Missing posterior teeth Hypersensitivity to botulinum toxin.
结局指标
主要结局
Muscle thickness using ultrasound
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
LAFH
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
Clinical overbite
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
Posterior Dental height
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
Mandibular Plane angle
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
Muscle activity by EMG
时间窗: T0- before administration of botulinum toxin masseter | T1- immediately after administration of botulinum toxin in the masseter | T2- 3 months after administration of botulinum toxin in the masseter
次要结局
- masseter muscle activity via EMG(masseter muscle thickness using ultrasound)