Healthy ParticipantsNCT07431801
Application Of Dentapen In Dental Local Infiltration Anesthesia
A study of Healthy Participants and Tooth Extraction, run by Son Hoang Le at 1 site in Vietnam.
Trial summary
The goal of this clinical study is to compare patients' self-reported pain and mental stress during infiltration anesthesia between conventional syringe and Dentapen. Outcome 1: VAS score of self-reported pain during dental anesthesia Outcome 2: Heart rate variability during dental anesthesia Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Tooth Extraction, Orthodontic Patients
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2023to 1 Feb 2025
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- absence of cardiovascular disease
- tooth extraction indication of orthodontist
- no allgergy with any medications used in this study
- bilaterally symmetrical maxillary premolars
- the extracted promolars are in the same clinical condition
Who cannot join
- has been diagnosed with any mental diseases
- pregnancy patient
- individuals with alcohol or subtance use disorder
- local inflammation at injection site
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 72714
About this study
Official title: The Efficiacy Of Dental Electronic Syringe In Reducing Disconfort During Local Infiltration Anesthesia
The goal of this clinical study is to compare patients' self-reported pain and mental stress during infiltration anesthesia between conventional syringe and Dentapen.
Outcome 1: VAS score of self-reported pain during dental anesthesia Outcome 2: Heart rate variability during dental anesthesia
- Conditions
- Healthy Participants, Tooth Extraction, Orthodontic Patients
- Being tested
- computer controlled local anesthesia delivery device (Dentapen), Control
- Keywords
- heart rate variability, CCLAD, dental anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer controlled local anesthesia delivery device (Dentapen)Device
The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device.
ControlDevice
Conventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dentapen | Experimental | On the experimental side, researcher used Dentapen, a Computer-Controlled Local Anaesthetic Delivery device, to deliver anesthesia for patients. Receives: Device: computer controlled local anesthesia delivery device (Dentapen) |
| Control | Active comparator | This arm was admistered local anesthesia with conventional syringe Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Heart rate variability (HRV) is is the precise measure of the variation in time (milliseconds) between consecutive heartbeats. HRV is measured using a device around patient chest.
Measured: From enrollment to the end of tooth extraction treatment at 4 weeks. Each patient experienced two extraction treatments with 4-week interval.
Self-reported pain
Patients reported how much pain intensity that they feel during dental anesthesia by using a visual analogue scale. Scale value ranges from 0 (no pain) to 100 (maximum pain).
Measured: Patients reported right after dental anesthesia delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Aug 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Model description
- A split-mouth clinical trial in which one side is injected with conventional dental syringe, the other side is injected with Dentapen.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Son Hoang Le
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Son Hoang Le, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431801
- Sponsor's protocol ID
- 723/HĐĐĐ-ĐHYD
- Other IDs
- HĐ
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiacy Of Dental Electronic Syringe In Reducing Disconfort During Local Infiltration Anesthesia
- ClinicalTrials.gov ID
- NCT07431801
- Acronym / sponsor ID
- 723/HĐĐĐ-ĐHYD
- Conditions
- Healthy Participants, Tooth Extraction, Orthodontic Patients
- Keywords
- heart rate variability, CCLAD, dental anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Son Hoang LeUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 25 Feb 2026 (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.
The goal of this clinical study is to compare patients' self-reported pain and mental stress during infiltration anesthesia between conventional syringe and Dentapen.
Outcome 1: VAS score of self-reported pain during dental anesthesia Outcome 2: Heart rate variability during dental anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A split-mouth clinical trial in which one side is injected with conventional dental syringe, the other side is injected with Dentapen.
| Arm | Type | Receives |
|---|---|---|
| Dentapen | Experimental | Device: computer controlled local anesthesia delivery device (Dentapen)On the experimental side, researcher used Dentapen, a Computer-Controlled Local Anaesthetic Delivery device, to deliver anesthesia for patients. |
| Control | Active comparator | Device: ControlThis arm was admistered local anesthesia with conventional syringe |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- absence of cardiovascular disease
- tooth extraction indication of orthodontist
- no allgergy with any medications used in this study
- bilaterally symmetrical maxillary premolars
- the extracted promolars are in the same clinical condition
Key exclusion criteria (4 listed)
- has been diagnosed with any mental diseases
- pregnancy patient
- individuals with alcohol or subtance use disorder
- local inflammation at injection site
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 |
|---|---|---|
| computer controlled local anesthesia delivery device (Dentapen)The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device. | Device | Dentapen |
| ControlConventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia. | Device | Control |
Primary outcome
Heart rate variability
Time frame: From enrollment to the end of tooth extraction treatment at 4 weeks. Each patient experienced two extraction treatments with 4-week interval.
Heart rate variability (HRV) is is the precise measure of the variation in time (milliseconds) between consecutive heartbeats. HRV is measured using a device around patient chest.
Self-reported pain
Time frame: Patients reported right after dental anesthesia delivery.
Patients reported how much pain intensity that they feel during dental anesthesia by using a visual analogue scale. Scale value ranges from 0 (no pain) to 100 (maximum pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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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 of Healthy Participants and Tooth Extraction, run by Son Hoang Le at 1 site in Vietnam.
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 4 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: finished, as of the sponsor's last update on 25 Feb 2026. 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 Vietnam. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate variability (time frame: From enrollment to the end of tooth extraction treatment at 4 weeks. Each patient experienced two extraction treatments with 4-week interval.). The study lists 2 primary outcomes in all. 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 25 Feb 2026.