Comparing Pain and Anxiety of Dental Anesthesia Injector Versus Traditional Syringe in Children Aged 6 to 8 Years
Led by Ain Shams University · Updated on 2025-08-03
40
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to compare pain and anxiety levels in children aged 6 to 8 years undergoing dental treatment with two methods of local anesthesia a dental anesthesia injector device and the traditional syringe. The study focuses on healthy, cooperative pediatric patients who have deeply carious maxillary primary molars with reversible pulpitis and require buccal infiltration anesthesia before pulpotomy. The goal is to find a method that reduces pain and anxiety during dental injections.
Participants will receive topical lidocaine anesthesia for one minute on dried mucosa before local anesthesia administration using either the dental anesthesia injector or the conventional syringe. Each child will experience both injection techniques on separate occasions, with the side of administration assigned randomly right or left. The study uses a split-mouth design, allowing direct comparison within the same patient.
During and immediately after injections, researchers will measure pain using a Visual Analogue Scale, anxiety with the Corah Dental Anxiety Scale, and physiological indicators like heart rate and oxygen saturation via a pulse oximeter. The need for additional anesthesia will also be assessed during the dental visit. The study includes careful monitoring and aims to evaluate which injection method provides a less painful and less anxiety-inducing experience for children.
CONDITIONS
Brief Title
Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
Research Team
S
Samaa Abdo Mahmoud, Demonstrator
S
Samaa Mahmoud Abd El Saeed, Demonstrator
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Undergoing the first dental local anesthesia experience
Presence of at least one vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
Score 3 or 4 on Frankl scale of child behavior
You will not qualify if you...
Presence of gingivitis, dental abscess, or facial trauma/injury
Use of analgesic medication within 48 hours before randomization
Known allergy to local anesthesia
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day 1 for each injection method on separate visits
Participants receive local anesthesia injections using both a dental anesthesia injector device and a conventional syringe on separate occasions to compare pain and anxiety levels.
2 visits (in-person), one for each injection method
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
A Randomized Clinical Trial Comparing Fast and Conventional Curing Modes for Composite Fillings in Primary Molars
Randomized Trial of Vitamin D Supplements and Fluoride Treatments for Early Tooth Decay in People Aged 12 to 50
Community-Based School Hydration Program to Improve Water Use, Body Weight, and Dental Health in Children
Evaluating Digital Technologies to Detect Dental Cavities in Adults Aged 18 to 65
Comparing Pain and Anxiety of Dental Anesthesia Injector Versus Traditional Syringe in Children Aged 6 to 8 Years
Study of Dental Caries and Related Risk Factors in Patients Aged 35 to 44 at Cairo Universitys Faculty of Dentistry
Comparing Cention N and Resin Composite to Restore Cavities in Childrens First Permanent Molars A 12-Month Split-Mouth Randomized Trial Assessing Clinical and Quality of Life Outcomes
Evaluating Photobiomodulation with MTA Pulpotomy for Healing Irreversible Pulpitis in Young Childrens First Permanent Molars
Comparing Bioactive Bulk-Fill and Conventional Composites in Class II Dental Restorations
A Prospective Clinical Study in Adults 18 to 50 Years
Comparison of Direct Pulp Capping Outcomes in Deep Versus Extremely Deep Caries in Mature Permanent Lower Molars with Reversible Pulpitis