None listed
Conditions
Brief 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.
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 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
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)
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
It is anticipated at least 185 subjects will be recruited. Consecutive patients who meet the following criteria will be recruited: 1. subject to be between the ages of 14 and 19 years old at the commencement of treatment 2. subject agrees, with consent of parent/guardian, to follow a strict analgesia protocol (see inclusion criteria 6.) during the first 48 hours of full fixed orthodontic therapy; 3. 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 4. subject to begin full orthodontic fixed appliance therapy as per the following appliance protocols: 0.022-inch slot MBT Low Profile Victory Series brackets 014 inch NiTi RMO Thermalloy plus archwires Elastomeric modules 5. subject to have had no dental extractions in the previous two weeks prior to the fitting of fixed appliances 6. 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 criteria
1. subject does not require prophylactic antibiotic coverage 2. subject has no systemic diseases 3. subject cannot be pregnant 4. subject has no contraindication to the use of NSAID
Outcome results
None listed