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

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

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 :

1. a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort.
2. a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner.
3. a group of patients in which nothing will be given to them during the course of treatment.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication; Pain and Discomfort
• Intervention / Treatment: Radiation: low-level laser therapy; Drug: Panadol-extra

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: low-level laser therapy; low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
Experimental: 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.	Drug: Panadol-extra; Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
No Intervention: Traditional Treatment; 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological General Well-being	Patients will be requested to fill in the Psychosocial General Well-being Index (PGWBI) before the commencement of treatment	One week before performing the first step in Orthodontic Appliance Installation (i.e. one week before separation)

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Amer M Owayda, DDS, MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria; Study Chair: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria; Study Director: Rashad T Murad, DDS MSc PhD, Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria

Publications and helpful links

General Publications

• Farzanegan F, Zebarjad SM, Alizadeh S, Ahrari F. Pain reduction after initial archwire placement in orthodontic patients: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):169-73. doi: 10.1016/j.ajodo.2011.06.042.
• Artes-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21.
• Choi SH, Kim JS, Cha JY, Hwang CJ. Effect of malocclusion severity on oral health-related quality of life and food intake ability in a Korean population. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):384-90. doi: 10.1016/j.ajodo.2015.08.019.
• Dominguez A, Velasquez SA. Effect of low-level laser therapy on pain following activation of orthodontic final archwires: a randomized controlled clinical trial. Photomed Laser Surg. 2013 Jan;31(1):36-40. doi: 10.1089/pho.2012.3360. Epub 2012 Dec 16.
• Gupta M, Kandula S, Laxmikanth SM, Vyavahare SS, Reddy SB, Ramachandra CS. Controlling pain during orthodontic fixed appliance therapy with non-steroidal anti-inflammatory drugs (NSAID): a randomized, double-blinded, placebo-controlled study. J Orofac Orthop. 2014 Nov;75(6):471-6. doi: 10.1007/s00056-014-0243-7. Epub 2014 Oct 31.
• Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain. A single-blind randomized clinical trial. Angle Orthod. 2013 Jul;83(4):611-6. doi: 10.2319/082012-665.1. Epub 2012 Dec 14.
• Long H, Wang Y, Jian F, Liao LN, Yang X, Lai WL. Current advances in orthodontic pain. Int J Oral Sci. 2016 Jun 30;8(2):67-75. doi: 10.1038/ijos.2016.24.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: UDDS-Ortho-03-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No