Pain Perception Comparison of Computerized vs Conventional Injection Methods

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129162
• Other study ID #: A0108023PP
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Mansoura University
• Contact: Osamah M Almekhlafi, Master
• Phone: 00201141630514
• Email: dr.osamah.sp[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

Inclusion Criteria:

1. Apparently healthy children (5-8) years old, and free from systemic diseases.

2. Children who require local anesthetic injection for any dental treatment.

3. Cooperative children (positive or definitely positive on Frankel's scale).

4. Children who have no contraindications to the usage of selected local anesthetic agents.

Exclusion Criteria:

• All that does not correspond to inclusion criteria.

Related Conditions & MeSH terms

• Local Anesthesia
• Pain Perception

Intervention

Device:
• Conventional Syringe
Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.
• STA Single Tooth Anesthesia® System.
Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.
• Star Pen anesthesia device.
Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scale of pain perception by Wong-Baker FACES Pain Rating scale	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).	Up to 12 weeks.
Primary	scale of pain perception by Sounds, eyes, and motor (SEM) scale.	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.	Up to 12 weeks.