Pain Perception Comparison of Computerized vs Conventional Injection Methods

November 10, 2023 updated by: Osamah Mohammed Abdulghani Almekhlafi, Mansoura University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Recruiting
        • Faculty of dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I: Control Group
Use a conventional syringe to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a conventional syringe to inject anesthetic solution by buccal infiltration (BI) technique.
Device: 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.
Device: 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.
Experimental: Group II: STA group
Use STA Wand® (CCLA) to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use STA Wand® (CCLA) to inject anesthetic solution by buccal infiltration (BI) technique.
Device: 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.
Device: Conventional Syringe
Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.
Experimental: Group III: Star pen group
Use a Star Pen device to inject anesthetic solution by the inferior alveolar nerve block (IANB) technique. Also, use a Star Pen device to inject anesthetic solution by buccal infiltration (BI) technique.
Device: 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.
Device: Conventional Syringe
Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 12 weeks.
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.
Up to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Salwa M Awad, Prof, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
  • Principal Investigator: Osamah M Almekhlafi, Master, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
  • Study Director: Rizk A Elagamy, PhD, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0108023PP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol to other researchers

IPD Sharing Time Frame

within 6 month

IPD Sharing Access Criteria

for anyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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