Healthy Participants, Orthodontic Patients, Tooth Extraction
Conditions
Keywords
heart rate variability, CCLAD, dental anesthesia
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
Interventions
DEVICEcomputer controlled local anesthesia delivery device (Dentapen)
The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device.
DEVICEControl
Conventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia.
Sponsors
Son Hoang Le
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were covered their face with a drape for masking the instrument was using.
Intervention model description
A split-mouth clinical trial in which one side is injected with conventional dental syringe, the other side is injected with Dentapen.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | 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 | 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). |
Countries
Vietnam
Outcome results
None listed