Clinical trial NCT03159520: Control of Pain From Braces With Patient Advice Sheets
Official title: A Randomised Clinical Trial of Advice Regarding Acupressure or NSAIDs for the Control of Orthodontic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Pain
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2017-05-18
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised parallel clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Single centred randomised controlled trial with subjects recruited from a hospital orthodontic outpatient department in Dundee Dental Hospital.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain experience
timeFrame: 7 days
Secondary outcomes:
measure: Impact of pain on sleep
timeFrame: 7 days
measure: Impact of pain on eating
timeFrame: 7 days
measure: Rescue medication
timeFrame: 7 days
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Dundee Dental Hospital
Study officials:
affiliation: University of Dundee
name: David R Bearn, BDS
role: PRINCIPAL_INVESTIGATOR
References: