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

NCT06242743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia, Local

Interventions

OTHER

Scalpel blade needles

Patients were assigned to IANB injection by double scalpel blade bevel needles.

OTHER

standard blade needles

Patients were assigned to IANB injection by standard blade bevel needles.

Sponsors & Collaborators

  • Hams Hamed Abdelrahman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-03-27
Completion
2024-03-27

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242743 on ClinicalTrials.gov