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Clinical Trials/NCT06129162
NCT06129162
Recruiting
N/A

A Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems

Mansoura University1 site in 1 country120 target enrollmentOctober 30, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain Perception
Sponsor
Mansoura University
Enrollment
120
Locations
1
Primary Endpoint
scale of pain perception by Wong-Baker FACES Pain Rating scale
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.

Detailed Description

The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.

Registry
clinicaltrials.gov
Start Date
October 30, 2023
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Osamah Mohammed Abdulghani Almekhlafi

Principal Investigator

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Apparently healthy children (5-8) years old, and free from systemic diseases.
  • Children who require local anesthetic injection for any dental treatment.
  • Cooperative children (positive or definitely positive on Frankel's scale).
  • Children who have no contraindications to the usage of selected local anesthetic agents.

Exclusion Criteria

  • All that does not correspond to inclusion criteria.

Outcomes

Primary Outcomes

scale of pain perception by Wong-Baker FACES Pain Rating scale

Time Frame: Up to 12 weeks.

The primary outcome was evaluated using Wong-Baker FACES Pain Rating scale. The child was briefly explained about each face and then asked to select the face that best described their feelings during the administration of local anesthesia. The scale consists of 6 cartoon faces depicting varying facial expressions, ranging from a very happy face (score 0) to a very sad one (score 10).

scale of pain perception by Sounds, eyes, and motor (SEM) scale.

Time Frame: Up to 12 weeks.

The primary outcome was evaluated using Sounds, eyes, and motor (SEM) scale. These responses are categorized on a scale ranging from 1-4 categories comfort, mild discomfort, moderately painful, and painful. Two pediatric dentists who are blind to injection devises will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two.

Study Sites (1)

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