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

D

Dow University of Health Sciences

Status

Active, not recruiting

Conditions

Pain Score

Treatments

Device: Needleless jet injector
Procedure: Conventional needle injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06934512
IRB-3820/DUHS/Approval/2025/73

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 24 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Needleless jet injector
Experimental group
Description:
Local anesthesia with needleless jet injector will be given on one site for the tooth extraction
Treatment:
Device: Needleless jet injector
Conventional needle injection
Experimental group
Description:
Local anesthesia with traditional needle will be given on another site for the tooth extraction
Treatment:
Procedure: Conventional needle injection

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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