Effectiveness of INJEX Versus Traditional Syringe During Restoration of Primary Teeth

NCT06576609 | Completed DMC

• 1 other identifier: University Jazan
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique. The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique. . The main questions it aims to answer are:

1. 1.To evaluate pain perception for restoration of primary molars with a needle free system in a pediatric population.
2. 2.To evaluate pain perception for restoration of Primary molars with needle syringe \[Traditional syringe system\] method in a pediatric population
3. 3.Time required to deliver anesthesia using needle free system vs Needle syringe \[ traditional syringe system\] Participants who enrolled in the study will be anesthetized according to the respective groups i,e INJEX (needle free system) and traditional dental needle system and restoration will be done.

Conditions

Child Behavior

Outcome Measures

Primary Outcomes (1)

• The Face, Legs, Activity, Cry, and Consolability (FLACC) Scale

  FLACC gives an observational pain scale during the delivery of anesthesia

  during and immediately after the delivery of anesthesia

Secondary Outcomes (4)

• Frankel Behaviour Rating Scale ( FBRS)

  before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia

• Pulse rate

  Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia

• Wong Baker Scale

  During and immediately after the delivery of anesthesia

• Time of local anesthesia administration

  during the delivery of anesthesia

Study Arms (2)

INJEX

EXPERIMENTAL

Needle less device

Device: INJEX [ Needle less anesthesia]

Needle syringe

ACTIVE COMPARATOR

traditional dental needle

Device: INJEX [ Needle less anesthesia]

Interventions

INJEX [ Needle less anesthesia] DEVICE

already described

Also known as: Syringe Needle [ Traditional technique]

INJEX; Needle syringe

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7 - 10 years
• Existence of deep carious Primary molar, indicated for Indirect pup capping.
• Complete physical and mental health without any confounding medical history
• Parents who gave written informed consent

You may not qualify if:

• Children below 7 years of age
• Children complaining of irreversible pulpitis.
• Children with Negative behaviour according to the wright's modification of
• Frankl Behaviour Rating scale (FBRS) during initial examination
• Children with medical or mentally compromised

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

College of Dentistry

Jizan, Jazan Region, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: February 16, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

SA (1)