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A Randomized Clinical Trial of the Effectiveness of Acupressure in Relieving Orthodontic Pain

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 10, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study description shortened, about 100 words
    • Publications: details revised at 2 of 2 entries
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Orthodontic treatment with fixed appliances often causes pain, which peaks within 24 hours after archwire placement and lasts for several days. Patients commonly use analgesics such as acetaminophen to relieve pain, as it has minimal impact on tooth movement compared to NSAIDs. However, nonpharmacological approaches, such as acupressure, may offer an alternative method for pain relief. Acupressure is a traditional Chinese medicine technique that involves applying pressure to specific points on the body to reduce pain and promote relaxation. This randomized clinical trial aims to compare the effectiveness of acupressure versus acetaminophen in relieving orthodontic pain during the first five days after initial archwire placement. Study Design and Methodology * A parallel-group, single-center, blinded, randomized trial at Almina Dental Clinics. * Participants will be randomly assigned to one of two groups (1:1 ratio): 1. Acetaminophen Group: Participants will take 500 mg of acetaminophen up to three times in the first 24 hours after archwire insertion. 2. Acupressure Group: Participants will apply pressure on two acupressure points (St 6 and St 3) up to five times in the first 24 hours. If pain persists, they may take acetaminophen. * Pain levels will be recorded using a Visual Analog Scale (VAS) twice daily for five days. * The Mann-Whitney U test will be used to compare pain scores between groups. Eligibility Criteria Inclusion Criteria: * Patients aged 12 years and older with full permanent dentition (excluding third molars). * Undergoing fixed orthodontic treatment for the first time. * Minimum crowding of 4 mm according to Little's Irregularity Index. * No systemic diseases, periodontal diseases, or acute/chronic oral pain. Exclusion Criteria: * Chronic use of analgesic medications. * Allergy or contraindications to acetaminophen. * Pregnant patients or those with cleft lip/palate. * Recent toothache or requiring tooth extractions. * Female patients during their menstrual period. Study Significance This study evaluates whether acupressure can be an effective, nonpharmacological alternative to acetaminophen for managing orthodontic pain. If proven effective, acupressure could offer a safe, noninvasive method for pain relief with fewer side effects. Ethical Considerations \& Dissemination * The study protocol will be reviewed and approved by an ethics committee. * The research is self-funded. * Results will be published in a scientific journal to contribute to orthodontic pain management research.
Trial Details
NCT Number NCT06812936
Lead Sponsor University of Baghdad
Conditions
(from sponsor)
Orthodontic Pain (D013850), Pain Management (D016146), Acupressure (D056351), Analgesics, Non-Narcotic (D000700), Acetaminophen (D000082)
Related terms Agnosia
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov