The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment
NCT ID: NCT03400111
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-09-15
2019-07-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
low-level laser therapy
low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
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.
Panadol-extra
Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
Traditional Treatment
Patients will not undergo any actual irradiation therapy or take any active tablets during orthodontic treatment.
No interventions assigned to this group
Interventions
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low-level laser therapy
low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
Panadol-extra
Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with psychological abnormalities.
* Patients with systematic diseases or being treated from chronic pain or headache.
15 Years
30 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Amer M Owayda, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
Mohammad Y Hajeer, DDS MSc PhD
Role: STUDY_CHAIR
Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
Rashad T Murad, DDS MSc PhD
Role: STUDY_DIRECTOR
Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria
Locations
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Department of Orthodontics, University of Damascus Dental School
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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UDDS-Ortho-03-2018
Identifier Type: -
Identifier Source: org_study_id
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