The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system.
The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients?
By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.
Patients classified as ASA I in general systemic health
Children between 7 and 10 years of age
Absence of any syndromic condition
No physical or mental disability
Patients with mild or severe systemic diseases or those undergoing medical treatment
Patients younger than 7 or older than 10 years of age
Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
Patients requiring urgent dental treatment
Crossover
Digital Anesthesia with SleeperOne 5
DeviceFor both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.
Infiltration Anesthesia with a Metal Cartridge Syringe
DeviceFor maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.
Mandibular Block Anesthesia with a Metal Cartridge Syringe
DeviceFor mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.
To assess the patient's pain level (Before and after anesthesia)
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
To assess the patient's pain level (During anesthesia)
The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity on a continuous spectrum, ranging from "no pain" to "worst imaginable pain." It consists of a 10 cm line with descriptive anchors at both ends. In our study, VAS will be applied as a 10 cm horizontal line marked at 1 cm intervals to quantify pain levels.
To assess the patient's pain level (During anesthesia)
Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.
To assess the patient's anxiety level (Before anesthesia )
The CFSS-DS is a validated psychometric scale developed in 1982 to assess dental anxiety in children. It includes items scored from 1 (not afraid) to 5 (very afraid). Total scores indicate anxiety levels as follows: \<38: No anxiety 38-45: Moderate dental anxiety \>45: Severe dental anxiety
Pulse rate measurement to assess opetator's anxiety (Before,after and during anesthesia)
The measurement will be performed using a pulse oximeter attached to the operator's fingertip.
Body temperature measurement to assess the operator's anxiety (Before,after and during anesthesia)
Tympanic Temperature Measurement Under stress or anxiety, adrenaline increases heart rate and body temperature. Tympanic thermometers measure core temperature through the tympanic membrane, providing accurate, non-invasive, and rapid readings. This method is effective in ICU settings for both adults and children, offering advantages like minimal infection risk and resistance to environmental changes.
Blood oxygen saturation measurement to assess operator's anxiety (Before,after and during anesthesia)
The measurement will be performed using a pulse oximeter attached to the operator's fingertip
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
