Orthodontic Appliance ComplicationCOPPASNCT03159520
Control of Pain From Braces With Patient Advice Sheets
A study testing Advice sheet in people with Orthodontic Appliance Complication, run by University of Dundee at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Advice sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 12-25
- malocclusion requiring treatment
- scheduled to begin orthodontic treatment
- requires fixed orthodontic braces on upper and lower teeth.
Who cannot join
- previous orthodontic treatment
- current use of analgesics
- contraindications to the use of NSAIDs
- previous acupressure experience
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Advice sheet
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advice sheetBehavioural
Advice on management of post orthodontic pain
| Study group | Role | What they receive |
|---|---|---|
| Advice on acupressure | Active comparator | Advice sheet on use of acupressure for post orthodontic pain Receives: Behavioral: Advice sheet |
| Advice on analgesics | Active comparator | Advice sheet on use of NSAID analgesics for post orthodontic pain Receives: Behavioral: Advice sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experience
Visual analogue scale
Measured: 7 days
Secondary outcomes (3)
Impact of pain on sleep
Impact of pain on sleep as recorded in pain diary
Measured: 7 days
Impact of pain on eating
Impact of pain on eating as recorded in pain diary
Measured: 7 days
Rescue medication
Need to use rescue medication to manage pain as recorded in pain diary
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start27 Jun 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised parallel clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Principal investigator, David Bearn, University of Dundee
- Investigators
- David R Bearn, BDS, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159520
- Sponsor's protocol ID
- 2017OR02
- Acronym
- COPPAS
- Status last verified
- Feb 2019
- First submitted
- 14 May 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial of Advice Regarding Acupressure or NSAIDs for the Control of Orthodontic Pain
- ClinicalTrials.gov ID
- NCT03159520
- Acronym / sponsor ID
- COPPAS / 2017OR02
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Advice on acupressure | Active comparator | Behavioral: Advice sheetAdvice sheet on use of acupressure for post orthodontic pain |
| Advice on analgesics | Active comparator | Behavioral: Advice sheetAdvice sheet on use of NSAID analgesics for post orthodontic pain |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged 12-25
- malocclusion requiring treatment
- scheduled to begin orthodontic treatment
- requires fixed orthodontic braces on upper and lower teeth.
Key exclusion criteria (5 listed)
- previous orthodontic treatment
- current use of analgesics
- contraindications to the use of NSAIDs
- previous acupressure experience
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advice sheetAdvice on management of post orthodontic pain | Behavioural | Advice on acupressure, Advice on analgesics |
Primary outcome
Pain experience
Time frame: 7 days
Visual analogue scale
3 secondary outcomes
Impact of pain on sleep
Time frame: 7 days
Impact of pain on eating
Time frame: 7 days
Rescue medication
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Bearn, BDS principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice sheet in people with Orthodontic Appliance Complication, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain experience (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.