Dental AnxietyNCT06434844
Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents
A study testing Auricular acupunctures in people with Dental Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Auricular acupunctures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Auricular acupunctures, Sham acupunctures
- Keywords
- dental anxiety, dental pain, auricular acupunctures
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupuncturesProcedure or surgery
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.
Sham acupuncturesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Auricular acupunctures; Procedure: Sham acupunctures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, immediately after the intervention. immediately after the surgery
Secondary outcomes (3)
Pain perceived
Pain measured by Visual Analog Scale. Scores range from 0-10, with her scores correlating with greater pain
Measured: Immediately after the intervention. immediately after the surgery
Psychological changes
Heart rate
Measured: Baseline, perioperatively, immediately after the surgery
Psychological changes
Saturation of peripheral oxygen (SpO2) measurement
Measured: Baseline, perioperatively, immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434844
- Sponsor's protocol ID
- UW23-024
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) and other supporting materials will be made available to other researchers upon valid requests to the PI of the study.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06434844
- Acronym / sponsor ID
- UW23-024
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, dental pain, auricular acupunctures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture | Experimental | Procedure: Auricular acupunctures, Procedure: Sham acupuncturesThe 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 comparator | Procedure: Auricular acupunctures, Procedure: Sham acupuncturesThe subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupuncturesAfter 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. | Procedure or surgery | 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture, 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture |
| Sham acupuncturesThe 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. | Procedure or surgery | 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture, 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture |
Primary outcome
Dental fear
Time frame: 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
3 secondary outcomes
Pain perceived
Time frame: Immediately after the intervention. immediately after the surgery
Psychological changes
Time frame: Baseline, perioperatively, immediately after the surgery
Psychological changes
Time frame: Baseline, perioperatively, immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) and other supporting materials will be made available to other researchers upon valid requests to the PI of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupunctures in people with Dental Anxiety, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental fear (time frame: Baseline, immediately after the intervention. immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.