Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2017-06-27
2019-01-31
Brief Summary
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Detailed Description
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If informed consent is obtained, then the subject details will be delivered to the trial coordinator for randomisation to one of the groups, NSAIDs or acupressure group.
All subjects who are eligible for inclusion will be advised of the nature and purpose of the trial. The total number of subjects recruited will be approximately 36 with the acupressure and NSAID group containing approximately 18 subjects each.
All subjects who meet the inclusion criteria will be informed of the study and written consent sought for their participation. Subjects will be recruited from the new patient clinics and routine treatment waiting list. .
The subjects will be asked to measure the level and duration of pain and discomfort using a pain diary to record their experiences using visual analogue scales (VAS). The pain diary will be completed from 4 hours to 7 days after treatment after the insertion of the first orthodontic aligning archwire.
Intervention Groups In the acupressure group the subjects will be given an advice sheet and advised to use a definitive acupressure point on the back of the hand region to control orthodontic pain.
In the NSAID group the subjects will be given an advice sheet and advised to take Ibuprofen for the orthodontic pain
Pain scores via VAS will be analysed at 4hours, 24 hours, and 7 days after the orthodontic treatment. The VAS consists of a horizontal line, 100 mm in length with descriptive words at each end of the line which act as anchors e.g. no pain, great pain. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Advice on acupressure
Advice sheet on use of acupressure for post orthodontic pain
Advice sheet
Advice on management of post orthodontic pain
Advice on analgesics
Advice sheet on use of NSAID analgesics for post orthodontic pain
Advice sheet
Advice on management of post orthodontic pain
Interventions
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Advice sheet
Advice on management of post orthodontic pain
Eligibility Criteria
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Inclusion Criteria
* malocclusion requiring treatment
* scheduled to begin orthodontic treatment
* requires fixed orthodontic braces on upper and lower teeth.
Exclusion Criteria
* current use of analgesics
* contraindications to the use of NSAIDs
* previous acupressure experience
* pregnant
12 Years
25 Years
ALL
No
Sponsors
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NHS Tayside
OTHER_GOV
University of Dundee
OTHER
Responsible Party
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David Bearn
Principal Investigator
Principal Investigators
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David R Bearn, BDS
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Locations
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Dundee Dental Hospital
Dundee, , United Kingdom
Countries
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Other Identifiers
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2017OR02
Identifier Type: -
Identifier Source: org_study_id
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