Malocclusion
Conditions
Keywords
Post-archwire orthodontic pain, Fixed orthodontic treatment, Chewing gum pain relief, Ibuprofen analgesia, Acupressure LI4 Hegu point
Brief 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.
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.
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.
Sponsors
Bahria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-archwire orthodontic pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Rescue analgesic consumption | Within 7 days following initial archwire placement. | Use of any additional analgesic medication beyond the assigned intervention. |
| Appliance-related complications | Within 7 days following initial archwire placement. | Mechanical issues occurring such as bracket debonding or wire displacement. |
Outcome results
None listed