Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000541808
Ethics application status
Approved
Date submitted
21/05/2012
Date registered
22/05/2012
Date last updated
24/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised prospective study of analgesic protocols for the management of orthodontic pain in relation to fitting of fixed appliances
Scientific title
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
Secondary ID [1] 280532 0
Nil
Universal Trial Number (UTN)
U1111-1130-9431
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain and discomfort in relation to the fitting of orthodontic fixed appliances (braces) to patients between the ages of 14 and 19 286509 0
Condition category
Condition code
Oral and Gastrointestinal 286770 286770 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 284895 0
Treatment: Drugs
Intervention code [2] 284907 0
Treatment: Devices
Comparator / control treatment
Control group takes placebo tablet (identical in size, shape and colour to the other tablets in the analgesia groups) 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)
Control group
Placebo

Outcomes
Primary outcome [1] 287155 0
To ascertain a difference firstly between the placebo and the analgesics for the prevention of orthodontic pain in relation to fitting of braces.
Timepoint [1] 287155 0
Patients will record their level of discomfort on a 100mm visual analogue scale over a 7 day period

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

To collect the number of patients it is anticipated it will take approximately 18months.

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 [1] 297513 0
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.
Timepoint [1] 297513 0
Patients will record their level of discomfort on a 100mm visual analogue scale over a 7 day period

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

To collect the number of patients it is anticipated it will take approximately 18months.

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.

Eligibility
Key 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)
Minimum age
14 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each subject will be informed of the study at the time of inital orthodontic consultation. After which, the subject and parent/guardian(s) will be asked at their next appointment if they are happy and consent to participating in the study.

After completing the patient consent form, patient's will be assigned a "Patient study number".

The Pharmacy preparing the medications has been given a randomisation table (block randomisation) for 185 patients. The pharmacy will return the medications to the orthodontic practice without a description of the patient's allocated medication (blinded) just their patient study number and their name / DOB.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All patients will receive the same type of orthodontic treatment from the same practice. Three orthodontists will provide this treatment. The medicines produced by the pharmacy will be in tablet form; all the same size, colour and shape.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
185
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285283 0
Charities/Societies/Foundations
Name [1] 285283 0
Australian Society of Orthodontists Foundation for Research and Education
Country [1] 285283 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
200 Turbot st
Brisbane, QLD, 4000
Country
Australia
Secondary sponsor category [1] 284143 0
Commercial sector/Industry
Name [1] 284143 0
Northside Orthodontics
Address [1] 284143 0
800 Gympie Rd,
Chermside, Brisbane, QLD, 4032
Country [1] 284143 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287297 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 287297 0
Ethics committee country [1] 287297 0
Australia
Date submitted for ethics approval [1] 287297 0
06/03/2012
Approval date [1] 287297 0
16/05/2012
Ethics approval number [1] 287297 0
2012000318

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34202 0
Address 34202 0
Country 34202 0
Phone 34202 0
Fax 34202 0
Email 34202 0
Contact person for public queries
Name 17449 0
Jonathan Rooke
Address 17449 0
200 Turbot St
Brisbane, QLD, 4000
Country 17449 0
Australia
Phone 17449 0
+61 7 33658069
Fax 17449 0
Email 17449 0
[email protected]
Contact person for scientific queries
Name 8377 0
Jonathan Rooke
Address 8377 0
200 Turbot St
Brisbane, QLD, 4000
Country 8377 0
Australia
Phone 8377 0
+61 7 33658069
Fax 8377 0
Email 8377 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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