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

Pain and discomfort in relation to the fitting of orthodontic fixed appliances (braces) to patients between the ages of 14 and 19

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

Inclusion Criteria19

It is anticipated at least 185 subjects will be recruited. Consecutive patients who meet the following criteria will be recruited:
subject to be between the ages of 14 and 19 years old at the commencement of treatment
subject agrees, with consent of parent/guardian, to complete a 100mm VAS at predetermined intervals within the first week of full fixed orthodontic therapy as follows:
T1: 2 hours after fitting of braces
T2: 6 hours after fitting of braces
T3: At night of fitting of braces
T4: 24 hours after fitting of braces
T5: 2 days after fitting of braces
T6: 3 days after fitting of braces
T7: 7 days after fitting of braces
subject to begin full orthodontic fixed appliance therapy as per the following appliance protocols:
022-inch slot MBT Low Profile Victory Series brackets
inch NiTi RMO Thermalloy plus archwires
Elastomeric modules
subject to have had no dental extractions in the previous two weeks prior to the fitting of fixed appliances
subject and parent/guardian consents to a randomly assigned analgesia protocol according to the following groups:
A) 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)
B) 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)
C) Control group takes placebo 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)

Exclusion Criteria4

subject does not require prophylactic antibiotic coverage
subject has no systemic diseases
subject cannot be pregnant
subject has no contraindication to the use of NSAID

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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