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

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.

NCT Number	NCT06812936
Lead Sponsor	University of Baghdad
Conditions	Orthodontic Pain (D013850), Pain Management (D016146), Acupressure (D056351), Analgesics, Non-Narcotic (D000700), Acetaminophen (D000082)
Enrollment	56 participants
Start Date	2025-02-10
Primary Completion	2025-09-30 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-10