Application Of Dentapen In Dental Local Infiltration Anesthesia

NCT07431801 | Completed DMC FDA Device

• 2 other identifiers: 723/HĐĐĐ-ĐHYDHĐ
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Participants; Tooth Extraction; Orthodontic Patients

Keywords

heart rate variability; CCLAD; dental anesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Patients reported right after dental anesthesia delivery.

Study Arms (2)

Dentapen

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

This arm was admistered local anesthesia with conventional syringe

Device: Control

Interventions

computer controlled local anesthesia delivery device (Dentapen) DEVICE

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

Dentapen

Control DEVICE

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

Control

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Son Hoang Le: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 72714, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were covered their face with a drape for masking the instrument was using.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: A split-mouth clinical trial in which one side is injected with conventional dental syringe, the other side is injected with Dentapen.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 25, 2026
• Study Start: August 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

VN (1)