Application Of Dentapen In Dental Local Infiltration Anesthesia

Son Hoang Le40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy Participants Tooth Extraction Orthodontic Patients

Interventions

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.

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Patients reported right after dental anesthesia delivery.

Data from ClinicalTrials.gov

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