Pain Perception Comparison of Computerized vs Conventional Injection Methods

NCT ID: NCT06129162

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Pain Perception Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Selected children will be divided randomly into 3 groups:

* Control group (Group I).
* STA group (Group II).
* Star pen group (Group III).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

STA Single Tooth Anesthesia® System.

Intervention Type DEVICE

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

Star Pen anesthesia device.

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Conventional Syringe

Intervention Type DEVICE

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

Star Pen anesthesia device.

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Conventional Syringe

Intervention Type DEVICE

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.

Intervention Type DEVICE

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

Interventions

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Conventional Syringe

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Osamah Mohammed Abdulghani Almekhlafi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osamah M Almekhlafi, Master

Role: PRINCIPAL_INVESTIGATOR

Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

Salwa M Awad, Prof

Role: STUDY_DIRECTOR

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

Rizk A Elagamy, PhD

Role: STUDY_DIRECTOR

Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

Locations

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Faculty of dentistry

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Osamah M Almekhlafi, Master

Role: CONTACT

00201141630514

Facility Contacts

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Osamah M Almekhlafi, Master

Role: primary

00201141630514

Other Identifiers

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A0108023PP

Identifier Type: -

Identifier Source: org_study_id

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