MalocclusionNCT07638644
Comparison of Acupressure, Ibuprofen, and Chewing Gum for the Management of Post-Archwire Orthodontic Pain
A study testing Acupressure, Ibuprofen 400 mg (if necessary) and Chewing Gum in people with Malocclusion, run by Bahria University.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Acupressure, Ibuprofen 400 mg (if necessary) and Chewing Gum
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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 informed consent provided (or parental/guardian consent for participants younger than 18 years)
Who cannot join
- 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
About this study
Official title: Comparative Efficacy of Acupressure, Ibuprofen, and Chewing Gum in Managing Post-Archwire Orthodontic Pain: A Three-Arm Randomized Clinical Trial
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:
Read more
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.
- Conditions
- Malocclusion
- Being tested
- Acupressure, Ibuprofen 400 mg (if necessary), Chewing Gum
- Keywords
- Post-archwire orthodontic pain, Fixed orthodontic treatment, Chewing gum pain relief, Ibuprofen analgesia, Acupressure LI4 Hegu point
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
Also called LI4 (Hegu) Acupressure
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.
Ibuprofen 400 mg (if necessary)Drug
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.
Chewing GumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Intervention | Experimental | 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. Receives: Behavioral: Acupressure |
| Ibuprofen Intervention | Active comparator | 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. Receives: Drug: Ibuprofen 400 mg (if necessary) |
| Chewing Gum Intervention | Experimental | 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. Receives: Behavioral: Chewing Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-archwire orthodontic pain
Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS).
Measured: 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 (2)
Rescue analgesic consumption
Use of any additional analgesic medication beyond the assigned intervention.
Measured: Within 7 days following initial archwire placement.
Appliance-related complications
Mechanical issues occurring such as bracket debonding or wire displacement.
Measured: Within 7 days following initial archwire placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Participants will be randomly assigned to one of three parallel groups: acupressure, ibuprofen, or chewing gum. Each group will receive a different intervention following placement of the initial orthodontic archwire, and outcomes will be assessed independently without crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumaila Maryum, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638644
- Sponsor's protocol ID
- BUHS-IRB#264/26
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Acupressure, Ibuprofen, and Chewing Gum in Managing Post-Archwire Orthodontic Pain: A Three-Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07638644
- Acronym / sponsor ID
- BUHS-IRB#264/26
- Conditions
- Malocclusion
- Keywords
- Post-archwire orthodontic pain, Fixed orthodontic treatment, Chewing gum pain relief, Ibuprofen analgesia, Acupressure LI4 Hegu point
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: acupressure, ibuprofen, or chewing gum. Each group will receive a different intervention following placement of the initial orthodontic archwire, and outcomes will be assessed independently without crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Acupressure Intervention | Experimental | Behavioral: AcupressureParticipants 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. |
| Ibuprofen Intervention | Active comparator | Drug: Ibuprofen 400 mg (if necessary)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. |
| Chewing Gum Intervention | Experimental | Behavioral: Chewing GumInstructions 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. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 15 to 35 years
- Complete permanent dentition
- Undergoing comprehensive fixed orthodontic treatment
- Scheduled for initial archwire placement
- Ability to comply with study procedures
Key exclusion criteria (8 listed)
- Pregnant or lactating
- Systemic disorders that may affect pain perception
- Periodontal disease
- Neurological abnormalities that may affect pain perception
- Known sensitivity to chewing gum
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 |
|---|---|---|
| AcupressureAlso: LI4 (Hegu) AcupressureParticipants 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. | Behavioural | Acupressure Intervention |
| Ibuprofen 400 mg (if necessary)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 Intervention |
| Chewing GumInstructions 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. | Behavioural | Chewing Gum Intervention |
Primary outcome
Post-archwire orthodontic pain
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
Pain experienced by patients following placement of the initial orthodontic archwire, measured using the Visual Analog Scale (VAS).
2 secondary outcomes
Rescue analgesic consumption
Time frame: Within 7 days following initial archwire placement.
Appliance-related complications
Time frame: Within 7 days following initial archwire placement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure, Ibuprofen 400 mg (if necessary) and Chewing Gum in people with Malocclusion, run by Bahria University.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Post-archwire orthodontic pain (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). 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 11 Jun 2026.