Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434844
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-16
Brief Title:
Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None