Type of Needle Bevel on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia

Effect of Needle Bevel Type on Pain Perception in Children During Inferior Alveolar Nerve Block Anesthesia (a Randomized Controlled Clinical Trial)

fear of the discomfort that comes with anesthetic needle insertion. For dental local anesthesia, needles with a scalpel-designed bevel have been claimed to decrease pain elicited by injection.

Objective of the study: The purpose of this study is to assess the effect of needle bevel on patient's perception of pain during inferior alveolar nerve block anesthesia and the needle tip will be further assessed for deformation.

Materials and Methods: The study will be a double-blind randomized controlled clinical trial, with a parallel design. A total of sixty-six healthy children will be selected from The Pediatric Dentistry and Dental Public Health Clinic, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankel behavioral rating scale. Written consent will be obtained from the legal guardian. Participants will be randomly allocated into two groups according to the type of needle bevel that will be used. Group I (test group) will receive inferior alveolar nerve block (IANB) using a double scalpel blade bevel needle, while group II (control group) will receive IANB using a standard blade bevel needle. All the procedures will be videotaped. Pain reaction will be evaluated subjectively using a face scale modified from the Maunuksela scale and objectively using the Sensory, Eye, and Motor (SEM) scale. After the respective single injection, the needles will be fixed on an object slide and prepared for microscopic examination.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Other: Scalpel blade needles; Other: standard blade needles

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy children with ASA I, II Classification.
• Children with no learning disabilities.
• Positive or definitely positive behavior according to the Frankl Scale.
• Patient requiring local anesthetic injection IANB for dental treatment.
• Written consent of the legal guardian.

Exclusion Criteria:

• Medically compromised patient.
• Children with emergency treatment needs, such as abscess, cellulitis and space infection.
• Hypersensitivity to local anesthetic drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: standard blade needles; Patients were assigned to IANB injection by standard blade bevel needles.
Experimental: Test group	Other: Scalpel blade needles; Patients were assigned to IANB injection by double scalpel blade bevel needles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Pain assessment	Sound, Eye, and Motor scales will be used for pain assessment by viewing the recorded videotapes for the patients during the dental procedure. it assesses changes in comfort level as follows; Comfort; Mild discomfort; Moderate discomfort; Severe discomfort higher scores mean higher discomfort Minimum score: 1 Maximum score: 12	During procedure
Subjective pain assessment	Each patient will be trained on using the scale by modeling and then requesting every patient to think of the last time she/he went through a painful experience and to choose the facial expression that best relates his/her current experience of discomfort to the previous one. Facial scales' categories are as follows Score A: Satisfied Score B Indifference Score C: Dissatisfaction	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle deformation	Needles will be evaluated under stereoscopic microscope to measure the amount of deformation or deviation in micorn meter from the original unused ones.	During procedure

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Keratolytic Agents; Pyrithione zinc
• Other Study ID Numbers: 0726_07/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No