The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Pain and Discomfort, Orthodontic Appliance Complication

Intervention / Treatment
-----------------
* Radiation: low-level laser therapy
* Drug: Panadol-extra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: Previous orthodontic treatment Patients with psychological abnormalities. Patients with systematic diseases or being treated from chronic pain or headache.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-level laser therapy<br>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. | Radiation: low-level laser therapy<br>* low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.<br>|
| Experimental: Panadol-extra<br>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. | Drug: Panadol-extra<br>* Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort<br>|
| No Intervention: Traditional Treatment<br>Patients will not undergo any actual irradiation therapy or take any active tablets during orthodontic treatment. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Levels of Pain and Discomfort_Separation | 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). | (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. | 
| Change in Levels of Pain and Discomfort_FirstArch | 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'. | (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. | 
| Change in Levels of Pain and Discomfort_SecondArch | 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'. | (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. | 
| Change in Levels of Pain and Discomfort_ThirdArch | 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'. | (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. | 
| Change in Levels of Pain and Discomfort_FouthArch | 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'. | (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. | 
| Change in Levels of Pain and Discomfort_LastArch | 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'. | (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. | 
| Change in Levels of Pain and Discomfort_Debonding | 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'. | (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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral-health-related quality of life_Separation | Patients will be given a questionnaire to be filled 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). This questionnaire is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled 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'. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled 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'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled 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'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled 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'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled 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'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes. | (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 | Patients will be given a questionnaire to be filled after appliance removal (i.e. taking off all the braces and bands). Assessment will be made at this stage which is called 'Appliance Removal'. | (1) one week following appliance removal, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days. |