Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).

NCT ID: NCT06934512

Last Updated: 2025-04-23

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-11-30

Brief Summary

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Dental anesthesia with needle injection cause fear and anxiety in patients about the dental procedures. Therefore, less painful anesthesia alternatives like needleless anesthesia devices to reduce the negative sensation of pain and fear that is always associated with traditional local anesthesia needle injection.

The jet injector with INJEX is a needleless injector system that injects the local anesthesia solution into the tissues through a pressure. This research aims to compare the pain score of jet injector with INJEX and traditional local anesthesia needle injection for teeth extraction.

Method:

50 patients visiting DOW Ojha Hospital, who needs extraction of bilateral teeth will be included in this study. Data collection approval will be taken from Institutional Review Board (IRB) of DUHS.

Complete procedure, study purpose and pain scale will be explained to patients and they will be told that information will be utilized for only research purpose and after that permission will be taken from participants.

After taking history, quadrants will be divided; one for local anesthesia by the Jet Injector with INJEX and one for traditional local anesthesia needle injection.

After that local anesthesia with Jet Injector INJEX will be given to one side and traditional local anesthesia needle injection will be given to other site for teeth extraction. Then principle investigator will examine the patient pain through the pain scale (Visual Analog Scale) of this study and supervisor will confirm it.

Detailed Description

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Conditions

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Pain Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Needleless jet injector

Local anesthesia with needleless jet injector will be given on one site for the tooth extraction

Group Type EXPERIMENTAL

Needleless jet injector

Intervention Type DEVICE

To assess the pain score through (VAS) scale of needleless jet injector for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.

Conventional needle injection

Local anesthesia with traditional needle will be given on another site for the tooth extraction

Group Type EXPERIMENTAL

Conventional needle injection

Intervention Type PROCEDURE

To assess the pain score through (VAS) scale of traditional needle injection for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.

Interventions

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Needleless jet injector

To assess the pain score through (VAS) scale of needleless jet injector for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.

Intervention Type DEVICE

Conventional needle injection

To assess the pain score through (VAS) scale of traditional needle injection for local anesthesia. Scale has minimum zero number that indicates best outcome and maximum number is ten that indicates worst outcome.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-24 years old patient
* Patients having permanent dentition who require bilateral anterior or premolar teeth extraction
* Orthodontic patients who requires bilateral extraction of premolars
* Patients who give informed consent to take part in study

Exclusion Criteria

* Patients with local anesthesia allergy
* Patients with localized inflammation/ localized abscess/tenderness at site of injection
* Patients who do not give informed consent to take part in study
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Iftikhar

Principal Investigator Dr. Zehra Iftikhar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Ishrat-ul-Ebad Institute of Oral Health Sciences

Karachi, Sindh, Pakistan

Site Status

Dow University of Health and Sciences

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRB-3820/DUHS/Approval/2025/73

Identifier Type: -

Identifier Source: org_study_id

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