Control of Pain From Braces With Patient Advice Sheets

NCT ID: NCT03159520

Last Updated: 2019-02-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2019-01-31

Brief Summary

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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

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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

Conditions

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Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised parallel clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Not possible to mask due to nature of intervention except for outcome assessor

Study Groups

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Advice on acupressure

Advice sheet on use of acupressure for post orthodontic pain

Group Type ACTIVE_COMPARATOR

Advice sheet

Intervention Type BEHAVIORAL

Advice on management of post orthodontic pain

Advice on analgesics

Advice sheet on use of NSAID analgesics for post orthodontic pain

Group Type ACTIVE_COMPARATOR

Advice sheet

Intervention Type BEHAVIORAL

Advice on management of post orthodontic pain

Interventions

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Advice sheet

Advice on management of post orthodontic pain

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Tayside

OTHER_GOV

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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David Bearn

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United Kingdom

Other Identifiers

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2017OR02

Identifier Type: -

Identifier Source: org_study_id

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