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

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):

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.

Conditions

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

Interventions

PROCEDURE

Acupressure

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.

DRUG

Acetaminophen

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."

Sponsors & Collaborators

• University of Baghdad

  lead OTHER

Principal Investigators

• Yassir Abdulkadhim Professor Dr. Yassir Abdulkadhim Yassir, Ph.D. (Orthodontics) (UK) · University of Baghdad

• Rawof R. Al Tuma, Ph.D. (Orthodontics) · College of Dentistry, University of Karbala, Iraq

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-10

Primary Completion

2025-09-30

Completion

2025-12-31

Countries

• Iraq

Study Locations