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

Damascus University

Status: Completed

Conditions: Orthodontic Appliance Complication; Pain and Discomfort

Treatments: Drug: Panadol-extra; Radiation: low-level laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03400111

UDDS-Ortho-03-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Low-level laser therapy

Experimental group

Description:

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.

Treatment:

Radiation: low-level laser therapy

Panadol-extra

Experimental group

Description:

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.

Treatment:

Drug: Panadol-extra

Traditional Treatment

No Intervention group

Description:

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