Comparison of a Needle-free Local Anesthetic Technique With Traditional Syringe [ Needle Syringe] Technique for the Restoration of Primary Molars and Permanent Molars

NCT06448507 | Completed DMC

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

Brief Summary

The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system \[Traditional syringe system\] for restoration of Primary and young permanent teeth. The main questions it aims to answer are:

1. 1.To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population.
2. 2.To evaluate pain perception for restoration of primary and young permanent tooth 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 \[ traditional syringe system\]

Conditions

Child Behaviour

Outcome Measures

Primary Outcomes (2)

• Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children

  FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia

  during and immediately after the delivery of anesthesia

• Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children

  Wong Baker Scale. Used to self-assess and effectively communicate the severity of pain they may be experiencing

  During and immediately after the delivery of anesthesia

Secondary Outcomes (3)

• Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children

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

• Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children

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

• Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children

  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: Syringe Needle [ Traditional technique]

Interventions

INJEX [Needle less anesthesia] DEVICE

already described

INJEX

Syringe Needle [ Traditional technique] DEVICE

described

Needle syringe

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7 - 14 years
• Existence of deep carious Primary and Permanent 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, 45142, Saudi Arabia

Location

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: May 17, 2024
• First Posted: June 7, 2024
• Study Start: January 16, 2024
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)