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

Phase 4

Recruiting

• Conditions: Pain and discomfort in relation to the fitting of orthodontic fixed appliances (braces) to patients between the ages of 14 and 19; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12612000541808
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To ascertain a difference firstly between the placebo and the analgesics for the prevention of orthodontic pain in relation to fitting of braces.[Patients will record their level of discomfort on a 100mm visual analogue scale over a 7 day period<br><br>T1: 2 hours after fitting of braces<br>T2: 6 hours after fitting of braces<br>T3: At night of fitting of braces<br>T4: 24 hours after fitting of braces<br>T5: 2 days after fitting of braces<br>T6: 3 days after fitting of braces<br>T7: 7 days after fitting of braces<br><br>To collect the number of patients it is anticipated it will take approximately 18months.<br><br>The collection of 185 patients, allowing for drop out, after performing a power calculation factoring in studies of similar design, will more than provide a statistical significance in relation to the primary outcome.]

Secondary Outcome Measures

Name	Time	Method
Secondly, to detect a difference between the two analgesic medications (ibuprofen and acetaminophen) for the prevention of orthodontic pain in relation to fitting of braces.[Patients will record their level of discomfort on a 100mm visual analogue scale over a 7 day period<br><br>T1: 2 hours after fitting of braces<br>T2: 6 hours after fitting of braces<br>T3: At night of fitting of braces<br>T4: 24 hours after fitting of braces<br>T5: 2 days after fitting of braces<br>T6: 3 days after fitting of braces<br>T7: 7 days after fitting of braces<br><br>To collect the number of patients it is anticipated it will take approximately 18months.<br><br>The collection of 185 patients, allowing for drop out, after performing a power calculation factoring in studies of similar design, will more than provide a statistical significance in relation to the secondary outcome.]