Assessment of Low-level Laser Therapy Versus Paracetamol-caffeine Efficacy in Controlling Pain During Fixed Orthodontic Treatment and Their Role in Enhancing Oral-health-related Quality of Life: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Levels of Pain and Discomfort_Debonding
研究概览
简要总结
Patients with class I malocclusion who have mild to moderate crowding will be treated in this study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to orthodontic treatment will be assessed. The effect of these two interventions on oral-health related quality of life during all stages of orthodontic treatment will be explored, i.e. at the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of brackets, (4) removal of the fixed appliances.
There are three groups :
- a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort.
- a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner.
- a group of patients in which nothing will be given to them during the course of treatment.
详细描述
The assessment of oral-health-related quality of life during the different stages of orthodontic treatment is probably unique in the literature.
The study will cover the different stages of orthodontic treatment from A to Z. In other words, patients will be followed up till the end of treatment at which fixed appliances are removed. Pain control will be accomplished in one arm using LLLT and in another arm by prescribing Panadol Extra®. A third group will be left without any medication or laser irradiation to serve as a control group.
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)
盲法说明
Patients in the first group will undergo active irradiation with low-level laser therapy but they will consume placebo tablets. Patients in the second group will consume real Panadol-extra tablets but they will be subjected to a placebo red-beam as if they are irradiated with a laser beam. Patients in the third group will be subjected to both placebo procedures (i.e. placebo red-beam and not low-level laser therapy and placebo tablets).
入排标准
- 年龄范围
- 15 Years 至 30 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 (2-5 mm of tooth-size-arch-length-discrepancy)..
- •Good oral hygiene and periodontal health
- •No need for any preparation for fixed orthodontic appliance.
- •No severe skeletal discrepancy (i.e. Class I skeletal relationship).
排除标准
- •Previous orthodontic treatment
- •Patients with psychological abnormalities.
- •Patients with systematic diseases or being treated from chronic pain or headache.
研究组 & 干预措施
Low-level laser therapy
Patients upper and lower jaws will be irradiated with low-level laser therapy at specific points on the alveolus around the teeth from the vestibular and lingual sides. This group of patients will be followed up till the end of treatment.
干预措施: low-level laser therapy (Radiation)
Panadol-extra
Patients will be given Panadol-extra (565 mg: 500 mg paracetamol and 65 mg caffeine) at specific time points to control pain and discomfort during orthodontic treatment. This group of patients will be followed up till the end of treatment.
干预措施: Panadol-extra (Drug)
结局指标
主要结局
Change in Levels of Pain and Discomfort_Debonding
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after appliance removal (i.e. taking off all the braces and bands). Assessment will be made at this stage which is called 'Appliance Removal'.
Change in Levels of Pain and Discomfort_LastArch
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the fifth (i.e. the last) arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Last Arch Placement'.
Change in Levels of Pain and Discomfort_Separation
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after performing the first step in orthodontic installation of the appliance, i.e. the separation stage where separators are placed between the molar teeth on both sides of the jaw and in both jaws. Separators are placed for seven days before cementing the bands (that surround the molar teeth).
Change in Levels of Pain and Discomfort_FirstArch
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after banding the molars and bonding the rest of the dental arches. Brackets are to be placed and the first archwire will be engaged. Assessment will be made at this stage which is called 'First Arch Placement'.
Change in Levels of Pain and Discomfort_SecondArch
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the second arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Second Arch Placement'.
Change in Levels of Pain and Discomfort_ThirdArch
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the third arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Third Arch Placement'.
Change in Levels of Pain and Discomfort_FouthArch
时间窗: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the fourth arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Fourth Arch Placement'.
次要结局
- Change in oral-health-related quality of life_Separation((1) one week following separation, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_FirstArch((1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_SecondArch((1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_ThirdArch((1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_FourthArch((1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_LastArch((1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)
- Change in oral-health-related quality of life_Debonding((1) one week following appliance removal, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.)