Clinical trial NCT06434844: Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents
Official title: Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents - A Crossover Double-Blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
dental pain
auricular acupunctures
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dental fear
timeFrame: Baseline, immediately after the intervention. immediately after the surgery
Secondary outcomes:
measure: Pain perceived
timeFrame: Immediately after the intervention. immediately after the surgery
measure: Psychological changes
timeFrame: Baseline, perioperatively, immediately after the surgery
measure: Psychological changes
timeFrame: Baseline, perioperatively, immediately after the surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
state: Hksar PRC
Study officials:
References: