Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents

NCT06434844 | Active Not Recruiting

• 1 other identifier: UW23-024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomised, double-blinded cross-over study aims to compare the effectiveness of auricular acupuncture (AA) with placebo sham acupuncture (PSA) in reducing dental anxiety, pain perception and physiological responses to stress and anxiety among adolescents during orthodontic extractions. Adolescents aged between 10-19 years old who are undergoing orthodontic treatments requiring bilateral premolar extractions will be invited to complete a validated questionnaire to record their dental anxiety level, oral health knowledge, attitudes, practices, demographic and socio-economic factors. During orthodontic extractions, physiological responses including heart rate and oxygen saturation will be measured with a fingertip pulse oximeter throughout the process. The participants will be allocated randomly to one of the two groups in the study. Group 1-- auricular acupuncture in their first orthodontic extraction visit and placebo sham acupuncture in their second orthodontic extraction visit. Group 2-placebo sham acupuncture in their first orthodontic extraction visit and auricular acupuncture their second orthodontic extraction visit. Both acupuncture interventions will be carried out by a Hong Kong registered Chinese medical practitioner. The acupuncture needles are kept in place for 20 minutes to exert its effect before the dental extraction. Placebo sham acupuncture will not cause any harm, but the acupuncture points have no reported effect on stress relief. The extraction of premolars will be performed by a Hong Kong registered dentist. Local anesthesia is injected to numb the respective site, then the premolar will be removed with forceps, followed by stopping the bleeding by biting firmly on gauze.

Conditions

Dental Anxiety

Keywords

dental anxiety; dental pain; auricular acupunctures

Outcome Measures

Primary Outcomes (1)

• Dental fear

  Self-reported dental fear measured by Spielberger State Trait Anxiety Inventory score, Scores range from 20 to 80, with higher scores correlating with greater anxiety

  Baseline, immediately after the intervention. immediately after the surgery

Secondary Outcomes (3)

• Pain perceived

  Immediately after the intervention. immediately after the surgery

• Psychological changes

  Baseline, perioperatively, immediately after the surgery

• Psychological changes

  Baseline, perioperatively, immediately after the surgery

Study Arms (2)

1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture

EXPERIMENTAL

The subjects will receive auricular acupuncture in the 1st visit and placebo sham acupuncture in the 2nd visit.

Procedure: Auricular acupunctures; Procedure: Sham acupunctures

1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture

SHAM COMPARATOR

The subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit.

Procedure: Auricular acupunctures; Procedure: Sham acupunctures

Interventions

Auricular acupunctures PROCEDURE

After disinfection of the external ear with 75% alcohol wipes, 018x 13 filiform needles (Mocm International Limited) will be used to perform the auricular acupunctures at the relaxation point, tranquilizer point and master cerebral point at the left and right external ears.

1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture; 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture

Sham acupunctures PROCEDURE

The auricular acupoints of finger, shoulder and tonsil will be targeted instead. These points are also located at the external ear and comparable to those in the intervention group. The external ear will be disinfected with 75% alcohol wipes. Auricular acupunctures with 018x 13 filiform needles (Mocm International Limited) will be carried out at the finger point, shoulder point and tonsil point of the left and right external ears.

1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture; 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Undergoing orthodontic treatment and require bilateral extraction of premolars.
• Have parental consent signed by their parent or guardian.
• Medically fit with either ASA I or II status
• Have not taken any medications, especially anxiolytics and antidepressants
• The premolars to be extracted should be fully erupted and without any signs of ankylosis.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hksar PRC, 999077, Hong Kong

Location

MeSH Terms

Conditions

Toothache

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both acupuncture interventions will be carried out by a Hong Kong licenced Chinese medical practitioner (CMP) with no involvement in data collection and assessment. A research assistant will be responsible for the randomisation and inform the CMP regarding the group allocation. The acupuncture needles are kept in place for 20 minutes before the dental treatment. The extractions of premolars will be performed by a licenced general dental practitioner who is blinded towards the types of acupuncture received, so as the patient and their parents or caretakers.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 30, 2024
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)