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

NCT03400111 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 :

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

Conditions

Pain and Discomfort; Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• 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.

Other Outcomes (1)

• Psychological General Well-being

  One week before performing the first step in Orthodontic Appliance Installation (i.e. one week before separation)

Study Arms (3)

Low-level laser therapy

EXPERIMENTAL

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

Panadol-extra

EXPERIMENTAL

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

Traditional Treatment

NO INTERVENTION

Patients will not undergo any actual irradiation therapy or take any active tablets during orthodontic treatment.

Interventions

low-level laser therapy RADIATION

low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.

Low-level laser therapy

Panadol-extra DRUG

Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort

Panadol-extra

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Previous orthodontic treatment
• Patients with psychological abnormalities.
• Patients with systematic diseases or being treated from chronic pain or headache.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (8)

• 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.

  PMID: 22814893 BACKGROUND

• 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.

  PMID: 26926026 BACKGROUND

• 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.

  PMID: 23240876 BACKGROUND

• 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.

  PMID: 22284284 BACKGROUND

• 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.

  PMID: 25355194 BACKGROUND

• 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.

  PMID: 23241006 BACKGROUND

• 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.

  PMID: 27341389 BACKGROUND

• Owayda AM, Hajeer MY, Al-Sabbagh R, Burhan AS, Darwich K, Aljabban O, Latifeh Y. A randomized controlled trial on the effectiveness of low-level laser therapy versus paracetamol-caffeine for pain control during overall orthodontic treatment. Sci Rep. 2025 Aug 22;15(1):30839. doi: 10.1038/s41598-025-16658-2.

  PMID: 40847180 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Amer M Owayda, DDS

  MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

• Rashad T Murad, DDS MSc PhD

  Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: September 15, 2017
• Primary Completion: March 15, 2019
• Study Completion: July 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)