Jet Injectors Versus Conventional Anesthetic Technique in Children

NCT06314984 | Completed

• 1 other identifier: A10040521
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was conducted to compare the needleless Comfort-in jet injector device and the conventional needle technique in terms of

1. 1.Pain level during the administration of local anesthesia in children.
2. 2.Their effectiveness during pulpotomy procedures in primary molars.

Conditions

Anesthesia

Keywords

Jet injector; Needle; Comfort-in; Pain perception; Needleless; Pediatric Dentistry

Outcome Measures

Primary Outcomes (4)

• Pain level during the administration of local anesthesia by Wong-Baker faces pain rating scale

  The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings while receiving local anesthesia. Assessment of Scores: 0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.

  During adminstration of local anesthesia procedures.

• Pain levels during pulpotomy procedures steps by Wong-Baker faces pain rating scale

  The first scale is the Wong-Baker FACES Pain Rating scale, a subjective scale. The child was shown a collection of six cartoon faces with a variety of facial expressions, from a very happy face to a very sad face. The child was given a brief explanation of each face before being told to select the one that best reflected his or her feelings during the steps of pulpotomy procedure. Assessment of Scores: 0= No Hurt 2= Hurts Little Bit 4= Hurts Little More 6= Hurts Even More 8= Hurts Whole Lot 10= Hurts Lots the description of the faces: Face 0 is very happy because he doesn't hurt at all. Face 1 hurts just a little bit. Face 2 hurts a little more. Face 3 hurts even more. Face 4 hurts a whole lot more. Face 5 hurts as much as you can imagine, although you do not have to be crying to feel this bad.

  During the pulpotomy procedure.

• Pain level during administration of local anesthesia in children by FLACC scale.

  The second scale is theFace, Legs, Activity, Cry, and Consolability \[FLACC scale\], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the administration of anesthesia. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

  During adminstration of local anesthesia procedures.

• Pain levels during pulpotomy procedures steps by FLACC scale.

  The second scale is the Face, Legs, Activity, Cry, and Consolability \[FLACC scale\], an objective scale, which was used to measure pain according to Face, Legs, Activity, Cry, and Consolability. An assistant was well-trained to measure and calibrate the FLACC scale during the pulpotomy procedure. Each category receives a score between 0 and 2, giving a final score between 0 and 10.Assessment of Scores: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

  During the pulpotomy procedure.

Study Arms (4)

Group I A (Conventional neddle syringe)

ACTIVE COMPARATOR

The injection was done in the mandible by the conventional needle syringe \[Inferior Alveolar Nerve Block\].

Other: Group I A (Conventional needle syringe)

Group I B (Conventional needle syringe)

ACTIVE COMPARATOR

The injection was done in the maxilla by the conventional needle syringe \[Infiltration\].

Other: Group I B (Conventional needle syringe)

Group II A (Comfort-in Jet Injector)

EXPERIMENTAL

The injection was done in the mandible by the needleless Comfort-in jet injector \[Inferior Alveolar Nerve Block\].

Device: Group II A (Comfort-in Jet Injector)

Group II B (Comfort-in Jet Injector)

EXPERIMENTAL

The injection was done in the maxilla by the needleless Comfort-in jet injector \[Infiltration\].

Device: Group II B (Comfort-in Jet Injector)

Interventions

Group I A (Conventional needle syringe) OTHER

The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the conventional needle syringe \[Inferior Alveolar Nerve Block\].

Group I A (Conventional neddle syringe)

Group I B (Conventional needle syringe) OTHER

The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the conventional needle syringe \[Infiltration\].

Group I B (Conventional needle syringe)

Group II A (Comfort-in Jet Injector) DEVICE

The injection site was isolated using a cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the mandible by the needleless Comfort-in jet injector \[Inferior Alveolar Nerve Block\].

Group II A (Comfort-in Jet Injector)

Group II B (Comfort-in Jet Injector) DEVICE

The injection site was isolated using cotton roll and the topical anesthesia (Benzocaine 4%) was applied to the injection site and left for 3-5 minutes then the injection was done in the maxilla by the needleless Comfort-in jet injector \[Infiltration\].

Group II B (Comfort-in Jet Injector)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who require local anesthetic injection for pulpotomy.
• Cooperative children (positive or definitely positive on Frankel's scale).
• Children who had no previous dental local anesthetic experience, to avoid the influence of a negative or positive memory.
• Children who have been determined to be healthy and free of systemic diseases.
• Children who do not have any contraindications for administering a local anesthetic agent.

You may not qualify if:

• Children suffering from medical illness, neurosensory disturbances, and psychiatric disorders.
• Children who could not comprehend the pain measures.
• Children with emergencies and acute dental conditions.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University.

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant lecturer at pediatric dentistry department, Mansoura University

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 18, 2024
• Study Start: July 21, 2021
• Primary Completion: November 15, 2022
• Study Completion: March 21, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)