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

NCT06934512 | Active Not Recruiting DMC

• 1 other identifier: IRB-3820/DUHS/Approval/2025/73
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain Score

Keywords

Pain score

Outcome Measures

Primary Outcomes (1)

• CLINICAL COMPARISON OF PAIN SCORE OF NEEDLELESS JET INJECTOR AND CONVENTIONAL NEEDLE INJECTION FOR TEETH EXTRACTION ANESTHESIA (SPLIT MOUTH TECHNIQUE)

  Peri operative

Study Arms (2)

Needleless jet injector

EXPERIMENTAL

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

Device: Needleless jet injector

Conventional needle injection

EXPERIMENTAL

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

Procedure: Conventional needle injection

Interventions

Needleless jet injector 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.

Needleless jet injector

Conventional needle injection 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.

Conventional needle injection

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

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

Karachi, Sindh, 775500, Pakistan

Location

Dow University of Health and Sciences

Karachi, Sindh, Pakistan

Location

Study Design

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

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: February 20, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)