Pain Perception Comparison of Computerized vs Conventional Injection Methods

NCT06129162 | Unknown

• 1 other identifier: A0108023PP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception; Local Anesthesia

Keywords

Pain perception; Inferior Alveolar Nerve; Infiltration; Local Anesthesia; STA Single Tooth Anesthesia® System; Star Pen anesthesia device; Conventional syringe

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (3)

Group I: Control Group

ACTIVE COMPARATOR

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.; Device: Star Pen anesthesia device.

Group II: STA group

EXPERIMENTAL

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: Conventional Syringe; Device: Star Pen anesthesia device.

Group III: Star pen group

EXPERIMENTAL

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: Conventional Syringe; Device: STA Single Tooth Anesthesia® System.

Interventions

Conventional Syringe DEVICE

Dental local anesthesia injection is given by conventional syringe by two injection methods inferior alveolar nerve block and buccal infiltration.

Group II: STA group; Group III: Star pen group

STA Single Tooth Anesthesia® System. DEVICE

Dental local anesthesia injection is given by STA device by two injection methods inferior alveolar nerve block and buccal infiltration.

Group I: Control Group; Group III: Star pen group

Star Pen anesthesia device. DEVICE

Dental local anesthesia injection is given by Star Pen anesthesia device by two injection methods inferior alveolar nerve block and buccal infiltration.

Group I: Control Group; Group II: STA group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Study Officials

• Osamah M Almekhlafi, Master

  Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

• Salwa M Awad, Prof

  Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

• Rizk A Elagamy, PhD

  Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Osamah M Almekhlafi, Master

CONTACT

00201141630514; dr.osamah.sp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Selected children will be divided randomly into 3 groups: * Control group (Group I). * STA group (Group II). * Star pen group (Group III).

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 13, 2023
• Study Start: October 30, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within 6 month
• Access Criteria: for anyone

Locations

EG (1)