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

ConditionMalocclusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorBahria University

About this 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:

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 15 to 35 years

Complete permanent dentition

Undergoing comprehensive fixed orthodontic treatment

Scheduled for initial archwire placement

Disqualifiers

Pregnant or lactating

Systemic disorders that may affect pain perception

Periodontal disease

Neurological abnormalities that may affect pain perception

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Acupressure InterventionExperimental treatment 1 intervention
Group B: Ibuprofen InterventionActive comparator 1 intervention
Group C: Chewing Gum InterventionExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: