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

Not Applicable

Active, not recruiting

• Conditions: Dental Anxiety
• Interventions: Procedure: Auricular acupunctures; Procedure: Sham acupunctures

• Registration Number: NCT06434844
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture	Sham acupunctures	The subjects will receive auricular acupuncture in the 1st visit and placebo sham acupuncture in the 2nd visit.
1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture	Auricular acupunctures	The subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit.
1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture	Auricular acupunctures	The subjects will receive auricular acupuncture in the 1st visit and placebo sham acupuncture in the 2nd visit.
1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture	Sham acupunctures	The subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit.

Primary Outcome Measures

Name	Time	Method
Dental fear	Baseline, immediately after the intervention. immediately after the surgery	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

Secondary Outcome Measures

Name	Time	Method
Psychological changes	Baseline, perioperatively, immediately after the surgery	Saturation of peripheral oxygen (SpO2) measurement
Pain perceived	Immediately after the intervention. immediately after the surgery	Pain measured by Visual Analog Scale. Scores range from 0-10, with her scores correlating with greater pain

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hksar PRC, Hong Kong