RecruitingPhase 4ACTRN12612000541808

A randomised prospective study of analgesic protocols for the management of orthodontic pain in relation to fitting of fixed appliances

A randomised prospective study of analgesic protocols involving Ibuprofen and Acetaminophen (Paracetamol) for the management of orthodontic pain and discomfort in relation to fitting of fixed appliances in patients aged 14-19


Sponsor

The University of Queensland

Enrollment

185 participants

Start Date

May 24, 2012

Study Type

Interventional

Conditions

Summary

Investigation into the efficacy of the analgesic medications ibuprofen and acetaminophen (paracetamol) for the prevention of pain and discomfort in relation to the first 48 hours of fixed orthodontics treatment (braces). The study is a double blinded investigation with a placebo control group.


Eligibility

Sex: Both males and femalesMin Age: 14 YearssMax Age: 19 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether taking pain medication before and after getting braces fitted can reduce the discomfort that commonly occurs in the first 48 hours of orthodontic treatment. Participants will be randomly assigned to take either ibuprofen, paracetamol (acetaminophen), or a placebo (inactive pill) starting one hour before the braces are fitted. Pain levels will be recorded at several time points over the first week of treatment. You may be eligible if: - You are between 14 and 19 years old - You are about to start full fixed orthodontic treatment (braces) for the first time - You have not had a dental extraction in the past two weeks - You are willing to follow a strict pain medication schedule and complete pain rating forms You may NOT be eligible if: - You need to take preventive antibiotics before dental procedures - You have a systemic disease - You are pregnant - You have a reason you cannot take anti-inflammatory medications (NSAIDs) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Analgesic medications (provided as as a single oral tablet for each dose) NOTE: All tablets prepared in this study will be identical in size, shape and colour (ibuprofen, acetaminophen and placebo

Analgesic medications (provided as as a single oral tablet for each dose) NOTE: All tablets prepared in this study will be identical in size, shape and colour (ibuprofen, acetaminophen and placebo tablets) 400mg Ibuprofen 1hr prior to ligating the orthodontic arch wire to the braces using elastomeric modules (taking appoximately 5mins) and continuing on regular dosages as prescribed (as per therapeutic guidelines 4 hourly) for first 48hrs after band-up (the process of attaching the orthodontic braces or brackets to the teeth - takes approximately 30 minutes) 500mg Acetaminophen 1hr prior to ligating the orthodontic arch wire to the braces using elastomeric modules (taking appoximately 5mins) and continuing on regular dosages as prescribed (as per therapeutic guidelines 4 hourly) for first 48hrs after band-up (the process of attaching the orthodontic braces or brackets to the teeth - takes approximately 30 minutes)


Locations(1)

Australia

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ACTRN12612000541808