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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Препарат 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.
• Поведенческое Chewing 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.

Первичные конечные точки

• Post-archwire orthodontic pain [Срок оценки: 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]

Вторичные конечные точки (2)

• Rescue analgesic consumption [Срок оценки: Within 7 days following initial archwire placement.]
• Appliance-related complications [Срок оценки: Within 7 days following initial archwire placement.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07638644 · BUHS-IRB#264/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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