Control of Pain From Braces With Patient Advice Sheets (COPPAS)

A Randomised Clinical Trial of Advice Regarding Acupressure or NSAIDs for the Control of Orthodontic Pain

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Behavioral: Advice sheet

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom, DD1 4HR
    • Dundee Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Advice on acupressure; Advice sheet on use of acupressure for post orthodontic pain	Behavioral: Advice sheet; Advice on management of post orthodontic pain
Active Comparator: Advice on analgesics; Advice sheet on use of NSAID analgesics for post orthodontic pain	Behavioral: Advice sheet; Advice on management of post orthodontic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain experience	Visual analogue scale	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of pain on sleep	Impact of pain on sleep as recorded in pain diary	7 days
Impact of pain on eating	Impact of pain on eating as recorded in pain diary	7 days
Rescue medication	Need to use rescue medication to manage pain as recorded in pain diary	7 days

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: NHS Tayside
• Investigators: Principal Investigator: David R Bearn, BDS, University of Dundee

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pain
• Other Study ID Numbers: 2017OR02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No