Orthodontic Appliance Complication Clinical Trial
— COPPASOfficial title:
A Randomised Clinical Trial of Advice Regarding Acupressure or NSAIDs for the Control of Orthodontic Pain
NCT number | NCT03159520 |
Other study ID # | 2017OR02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 27, 2017 |
Est. completion date | January 31, 2019 |
Verified date | February 2019 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain following orthodontic treatment. This will be achieved by assessing the effectiveness of acupressure in controlling pain and discomfort by measuring the degree of pain relief after bonding of brackets to teeth and placement of initial archwire.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility |
Inclusion Criteria: - aged 12-25 - malocclusion requiring treatment - scheduled to begin orthodontic treatment - requires fixed orthodontic braces on upper and lower teeth. Exclusion Criteria: - previous orthodontic treatment - current use of analgesics - contraindications to the use of NSAIDs - previous acupressure experience - pregnant |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dundee Dental Hospital | Dundee |
Lead Sponsor | Collaborator |
---|---|
University of Dundee | NHS Tayside |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain experience | Visual analogue scale | 7 days | |
Secondary | Impact of pain on sleep | Impact of pain on sleep as recorded in pain diary | 7 days | |
Secondary | Impact of pain on eating | Impact of pain on eating as recorded in pain diary | 7 days | |
Secondary | Rescue medication | Need to use rescue medication to manage pain as recorded in pain diary | 7 days |
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