- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581249
This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth
May 5, 2026 updated by: Yassir R. Al-khannaq, University of Baghdad
Jet Injection for Extraction of Permanent Maxillary Teeth
Pain during administration of local anesthesia remains one of the major concerns in dental practice, often leading to anxiety and treatment avoidance.
Conventional syringe infiltration, while effective, is associated with discomfort during needle insertion and injection.
This study aimed to evaluate the effectiveness, patient comfort, and clinical applicability of jet injection as a needle-free alternative for maxillary tooth extractions.
A total of 80 adult patients were enrolled from the College of Dentistry, University of Baghdad, and Al-Amiriya Specialized Center for Dentistry between December 2024 and March 2025.
Jet injection with 2% lidocaine and 1:100,000 epinephrine was delivered buccally and palatally using the Comfort-In system, and patient responses were assessed through a visual analog scale and Likert-based subjective feedback.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Baghdad, Iraq
- University of Baghdad College of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- above 18 years of either gender
- had received dental anesthesia in the past with conventional syringe and needle
- required extraction on their maxillary teeth
- indicating their agreement to involving our study
Exclusion Criteria:
- adult with uncontrolled systemic conditions
- allergies to material used in this study
- patient who need surgical extraction
- intra-oral or facial swelling or presence of fistula or sinus tract
- patients who needed extraction to thier mandibular teeth patents refused to involve our study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Observasional group
|
The use of non aspirating dental syringe for delivery anesthesia to upper jaw
|
|
Experimental: Study group
Use of jet injection
|
The use of jet injectors to deliver anesthesia to upper jaw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue pain Scale
Time Frame: "Perioperative/Periprocedural
|
use of Visual Analogue pain Scale from 1-10 to assess the pain of injection
|
"Perioperative/Periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2024
Primary Completion (Actual)
March 1, 2025
Study Completion (Actual)
March 15, 2025
Study Registration Dates
First Submitted
August 31, 2025
First Submitted That Met QC Criteria
May 5, 2026
First Posted (Actual)
May 12, 2026
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 1040125
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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