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Completed

NCT Number: NCT03159520

Control of Pain From Braces With Patient Advice Sheets

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.

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dundee Dental Hospital

Dundee, DD1 4HR, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advice sheet

Behavioral

Advice on management of post orthodontic pain

Primary outcomes

  1. Pain experience

    Time frame: 7 days

    Visual analogue scale

Secondary outcomes

  1. Impact of pain on sleep

    Time frame: 7 days

    Impact of pain on sleep as recorded in pain diary

  2. Impact of pain on eating

    Time frame: 7 days

    Impact of pain on eating as recorded in pain diary

  3. Rescue medication

    Time frame: 7 days

    Need to use rescue medication to manage pain as recorded in pain diary

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • NHS Tayside

Registry information

Official study title

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

Acronym: COPPAS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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