Skip to main content
OpenTrials
Completed

NCT Number: NCT07431801

Application Of Dentapen In Dental 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants Orthodontic Patients Tooth Extraction

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 72714, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computer controlled local anesthesia delivery device (Dentapen)

Device

The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device.

Control

Device

Conventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia.

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Son Hoang Le

Other

Registry information

Official study title

The Efficiacy Of Dental Electronic Syringe In Reducing Disconfort During Local Infiltration Anesthesia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.