ClinicalTrials.gg
Not yet recruitingNCT07638644Updated Jun 11, 2026

Comparison of Acupressure, Ibuprofen, and Chewing Gum for the Management of Post-Archwire Orthodontic Pain

An interventional study of Acupressure and Ibuprofen 400 mg (if necessary) in Malocclusion, sponsored by Bahria University. Not yet recruiting. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Bahria University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
01

Study summary

The goal of this clinical trial is to find out which method works best to reduce pain after braces are adjusted for the first time (when the first archwire is placed). The study will compare three approaches: acupressure (applying pressure on a specific point on the hand), ibuprofen (a pain-relief medicine), and chewing sugar-free gum. It will also check how safe these methods are and whether patients need extra pain medicine.

The main questions the researchers want to answer are:

Which method reduces orthodontic pain the most after the first archwire is placed? Do patients need extra painkillers in any of the groups? Are there any problems with braces (such as loose brackets or wire issues) within the first week?

Researchers will compare the three groups to see which option gives the best pain relief during the first few days after braces are activated.

Participants will:

Be placed into one of three groups: acupressure, ibuprofen, or chewing gum Use their assigned method after their first orthodontic wire is placed Rate their pain at different time points using a simple pain scale (VAS) Report if they take any extra pain medicine Be checked for any brace-related problems for up to 7 days

This study may help improve comfort and pain management for patients starting orthodontic treatment.

02

Conditions studied

  • Malocclusion

Browse trials for

Keywords

  • Post-archwire orthodontic pain
  • Fixed orthodontic treatment
  • Chewing gum pain relief
  • Ibuprofen analgesia
  • Acupressure LI4 Hegu point
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 105 is above the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Bahria University is the lead sponsor of 36 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 15 to 35 years
  • Complete permanent dentition
  • Undergoing comprehensive fixed orthodontic treatment
  • Scheduled for initial archwire placement
  • Ability to comply with study procedures
  • Written provided (or parental/guardian consent for participants younger than 18 years)

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating
  • Systemic disorders that may affect pain perception
  • Periodontal disease
  • Neurological abnormalities that may affect pain perception
  • Known sensitivity to chewing gum
  • Documented allergy to ibuprofen
  • Use of adjunctive orthodontic appliances
  • Use of analgesics, anti-inflammatory medications, or other medications that may affect pain perception within 24 hours before enrollment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Acupressure Intervention

    Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire. Verbal instructions and a standardized advice sheet will be provided. Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes. The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border. Participants will be instructed to perform acupressure according to the standardized study protocol.

    Behavioral: Acupressure

  • Active comparator
    Ibuprofen Intervention

    In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement. With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.

    Drug: Ibuprofen 400 mg (if necessary)

  • Experimental
    Chewing Gum Intervention

    Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.

    Behavioral: Chewing Gum

Interventions

  • BehavioralAcupressure

    Participants in this arm will receive instructions on the use of acupressure for orthodontic pain management following placement of the initial archwire. Verbal instructions and a standardized advice sheet will be provided. Participants will be trained to apply steady, perpendicular pressure using the thumb of the opposite hand to the LI4 (Hegu) acupressure point for approximately 3 minutes. The location of the LI4 point will be demonstrated and identified as the point on the dorsum of the hand between the first and second metacarpal bones, at the midpoint of the second metacarpal bone near its radial border. Participants will be instructed to perform acupressure according to the standardized study protocol.

    Also known as: LI4 (Hegu) Acupressure

  • In the ibuprofen group participants will be provided with a 400 mg oral dose post arch wire placement. With a minimum gap of 8 hours between doses, remaining doses will be taken as per need for the relief of pain with the total daily dose not surpassing 1200 mg.

  • BehavioralChewing Gum

    Instructions to chew sugar-free gum for a period of 10 minutes immediately post arch wire placement will be provided to the chewing gum group, 8 hourly, for pain relief.

06

What researchers measure

Primary outcomes

  1. Post-archwire orthodontic pain

    Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS).

    Time frame: Pain levels will be recorded using a 10-cm visual analog scale (vas) at the following intervals: • 2 hours • 6 hours • Bedtime (day 1) • 24 hours (day 2) • Day 3 • Day 7

Secondary outcomes

  1. Rescue analgesic consumption

    Use of any additional analgesic medication beyond the assigned intervention.

    Time frame: Within 7 days following initial archwire placement.

  2. Appliance-related complications

    Mechanical issues occurring such as bracket debonding or wire displacement.

    Time frame: Within 7 days following initial archwire placement.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Feb 2027, 7 months later.

Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 7 months is below that.

Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2026
First posted
Jun 10, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Jun 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07638644
Lead sponsor
Bahria University
Responsible party
Shumaila Maryum (Principal Investigator, Bahria University) — Principal investigator
First posted
Jun 10, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jun 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion