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

NCT06242743 | Completed

• 1 other identifier: 0726_07/2023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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; 1. Comfort 2. Mild discomfort 3. Moderate discomfort 4. 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 Outcomes (1)

• Needle deformation

  During procedure

Study Arms (2)

Test group

EXPERIMENTAL

Other: Scalpel blade needles

Control group

ACTIVE COMPARATOR

Other: standard blade needles

Interventions

Scalpel blade needles OTHER

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

Test group

standard blade needles OTHER

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

Control group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2024
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

EG (1)