NCT03400111

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Not accepted

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. 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.

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.

Conditions

• Pain and Discomfort
• Orthodontic Appliance Complication

Interventions

Type	Name	Description
RADIATION	low-level laser therapy	low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
DRUG	Panadol-extra	Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort

Timeline

• Start date: 2017-09-15
• Primary completion: 2019-03-15
• Completion: 2019-07-01
• First posted: 2018-01-17
• Last updated: 2019-07-18

Locations

1 site across 1 country: Syria