Child Behavior After Local Anesthetic Injection Using Needless Systems

NCT ID: NCT05334433

Last Updated: 2023-09-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2023-05-20

Brief Summary

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The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique

Detailed Description

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Conditions

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Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Local anesthesia injection with the comfort in jet (Needless system)

A needle-less injection approach will be used to administer the local anesthetic solution

Group Type EXPERIMENTAL

Local anesthesia injection

Intervention Type PROCEDURE

Local anesthesia administration

Local anesthesia injection with needle injection (conventional technique).

A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution.

Group Type ACTIVE_COMPARATOR

Local anesthesia injection

Intervention Type PROCEDURE

Local anesthesia administration

Interventions

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Local anesthesia injection

Local anesthesia administration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
* Children who are medically fit.
* Children who are capable of interacting on a mental level.
* Children between the ages of 6 to 8.
* First dental visit.

Exclusion Criteria

* Children who struggle with behavioral control (uncooperative).
* Children who have a history of allergic reaction to local anesthetic drugs.
* Parental rejection for participation.
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ayatallah Elsayed Mohamed Aly Bassiouny

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Cairo University, Cairo, Egypt

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3399444

Identifier Type: -

Identifier Source: org_study_id

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