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NCT Number: NCT07638644

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

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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 informed consent provided (or parental/guardian consent for participants younger than 18 years)

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

Treatment and study plan

acupressure

Behavioral

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.

Other names: LI4 (Hegu) Acupressure

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 Gum

Behavioral

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.

Primary outcomes

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).

Secondary outcomes

Rescue analgesic consumption

Time frame: Within 7 days following initial archwire placement.

Use of any additional analgesic medication beyond the assigned intervention.
Appliance-related complications

Time frame: Within 7 days following initial archwire placement.

Mechanical issues occurring such as bracket debonding or wire displacement.

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Registry information

Official study title

Comparative Efficacy of Acupressure, Ibuprofen, and Chewing Gum in Managing Post-Archwire Orthodontic Pain: A Three-Arm Randomized Clinical Trial

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 10, 2026
Registry last updated: Jun 11, 2026

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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