Application Of Dentapen In Dental Local Infiltration Anesthesia

February 20, 2026 updated by: Son Hoang Le

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 72714
        • University of Medicine and Pharmacy at Ho Chi Minh City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • has been diagnosed with any mental diseases
  • pregnancy patient
  • individuals with alcohol or subtance use disorder
  • local inflammation at injection site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dentapen
On the experimental side, researcher used Dentapen, a Computer-Controlled Local Anaesthetic Delivery device, to deliver anesthesia for patients.
Device: computer controlled local anesthesia delivery device (Dentapen)
The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device.
Active Comparator: Control
This arm was admistered local anesthesia with conventional syringe
Device: Control
Conventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
Patients reported right after dental anesthesia delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Son Hoang Le

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 723/HĐĐĐ-ĐHYD
  • HĐ (Other Identifier: University of Medicine and Pharmacy at Ho Chi Minh City)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on computer controlled local anesthesia delivery device (Dentapen)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe