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

NCT06812936 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 911424
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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):
• Acetaminophen Group: Participants will take 500 mg of acetaminophen up to three times in the first 24 hours after archwire insertion.
• 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.

Conditions

Orthodontic Pain (D013850); Pain Management (D016146); Acupressure (D056351); Analgesics, Non-Narcotic (D000700); Acetaminophen (D000082)

Keywords

Orthodontic Pain; Pain Management; Acupressure Therapy; Acetaminophen (Paracetamol); Nonpharmacological Pain Relief; Orthodontic Treatment; Fixed Orthodontic Appliances; Visual Analog Scale (VAS)

Outcome Measures

Primary Outcomes (1)

• Comparative Evaluation of Acetaminophen and Acupressure for Pain Management in Orthodontic Treatment

  This study aims to compare the effectiveness of two pain management methods-acetaminophen (500mg) and acupressure-following the insertion of an archwire in orthodontic patients. Pain perception will be measured using a Visual Analog Scale (VAS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). The study will assess pain relief over the first five days post-treatment, with pain levels recorded twice daily on days 2 to 5, and once on day 1. Patients will either take acetaminophen or perform acupressure on specific points of the body (St 6 and St 36) to relieve discomfort. The goal is to determine which method provides more effective pain relief during the early stages of orthodontic treatment.

  From archwire insertion to 5 days post-bonding

Study Arms (2)

Acetaminophen Group

ACTIVE COMPARATOR

Participants in this group will be instructed to take acetaminophen 500mg, up to three times within the first 24 hours following the insertion of the archwire. The purpose of this intervention is to alleviate pain associated with orthodontic treatment. The analgesic effect of acetaminophen, which acts centrally to reduce pain, will be evaluated based on self-reported pain levels recorded using a visual analog scale (VAS) over the five-day post-bonding period.

Drug: Acetaminophen

Acupressure Group

EXPERIMENTAL

Participants in this group will be instructed on how to apply acupressure to two specific points: the Jaw Chariot (St 6) and Facial Beauty (St 36). They will be guided to apply firm pressure to these points up to five times within the first 24 hours after archwire insertion to alleviate pain associated with orthodontic treatment. The effectiveness of acupressure in pain management will be evaluated based on self-reported pain levels recorded using a visual analog scale (VAS) over the first five days post-bonding. If pain persists, participants may use acetaminophen as a supplementary pain management option.

Procedure: Acupressure

Interventions

Acetaminophen DRUG

This intervention involves the administration of acetaminophen 500mg tablets, taken up to three times within the first 24 hours following archwire insertion to manage pain associated with orthodontic treatment. Acetaminophen is a centrally acting analgesic that reduces pain without significantly affecting tooth movement, making it a preferred choice for pain relief in orthodontic patients. Participants will be instructed to record their pain levels using a visual analog scale (VAS) over a five-day period post-bonding to assess the effectiveness of this treatment."

Also known as: Paracetamol 500mg

Acetaminophen Group

Acupressure PROCEDURE

This intervention involves the application of acupressure to two specific acupressure points: Jaw Chariot (St 6) and Facial Beauty (St 36). Participants will be trained to apply firm pressure to these points up to five times within the first 24 hours after archwire insertion to alleviate orthodontic pain. Acupressure is a non-invasive therapy based on traditional Chinese medicine that aims to stimulate the body's natural healing processes and promote pain relief by balancing energy flow. Participants will be instructed to record their pain levels using a visual analog scale (VAS) over the first five days post-bonding to assess its effectiveness.

Acupressure Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have agreed to the research procedures and signed an informed consent form.
• Upper and lower comprehensive fixed orthodontic appliances (with no history of previous orthodontic treatment).
• They have a minimum crowding of 4mm according to Little's irregularity index (with no impactions/unerupted teeth).
• Patients with no systematic/periodontal diseases.
• If tooth extraction is needed, it is performed at least two weeks before fixed appliance placement or delayed after the study is completed.
• Patients aged 12 years and above with full permanent dentition (excluding the third molars)
• No current acute or chronic pain in the oral cavity.

You may not qualify if:

• Patients who have been using analgesic medications chronically or require prophylactic antibiotic coverage.
• Patients who are currently taking analgesics or antibiotics.
• Female patients being in the menstrual period.
• Patients with contraindications to the use of paracetamol (Hypersensitivity or anaphylaxis to any acetaminophen-like or -containing agents, in conjunction with alcohol, and patients with severe liver disease).
• Patients who have recently experienced a toothache.
• Patients who have a cleft lip or palate.
• Pregnant patients.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Almina Dental Clinics.

Karbala, Karbala Governorate, Iraq

Location

Related Publications (2)

• Chen YW, Wang HH. The effectiveness of acupressure on relieving pain: a systematic review. Pain Manag Nurs. 2014 Jun;15(2):539-50. doi: 10.1016/j.pmn.2012.12.005. Epub 2013 Feb 15.

  PMID: 23415783 BACKGROUND

• • Gach, M.R. (1990). Acupressure's potent points: A guide to self-care for common ailments, 1st ed., Bantam.

  BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Acupressure

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yassir Abdulkadhim Professor Dr. Yassir Abdulkadhim Yassir, Ph.D. (Orthodontics) (UK)

  University of Baghdad

  STUDY DIRECTOR

• Rawof R. Al Tuma, Ph.D. (Orthodontics)

  College of Dentistry, University of Karbala, Iraq

  STUDY DIRECTOR

Central Study Contacts

Ayat Mohammed Hussein, M.Sc. (Orthodontics)

CONTACT

+9647729435382; Drayaat420@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, investigators and outcomes assessors will be blinded to the intervention groups to minimize bias. The investigators responsible for data collection and pain assessment will not know whether participants received acupressure or acetaminophen. Similarly, the outcomes assessors analyzing the Visual Analog Scale (VAS) scores will be blinded to the group assignments to ensure unbiased statistical analysis. However, due to the nature of the interventions, participants cannot be blinded, as they will actively perform acupressure or take acetaminophen.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This randomized, parallel-group, single-center clinical trial compares the effectiveness of acupressure versus acetaminophen in managing orthodontic pain after initial archwire placement. Patients will be randomly assigned (1:1) to either the acupressure or acetaminophen group. Pain perception will be assessed using the Visual Analog Scale (VAS) over five days. The study employs single blinding, where investigators assessing outcomes are masked to group allocation. Randomization is conducted using a computer-generated sequence. This study aims to determine whether acupressure can be a viable alternative to analgesic medication for orthodontic pain management.

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: February 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)