Pain ScoreNCT06934512
Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).
A study testing Needleless jet injector and Conventional needle injection in people with Pain Score, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Pain Score
- What is being tested?
- Needleless jet injector and Conventional needle injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Feb 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Pakistan2 sites
Dr. Ishrat-ul-Ebad Institute of Oral Health Sciences
Karachi, Sindh, 775500
Dow University of Health and Sciences
Karachi, Sindh
About this study
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.
Read more
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
- Being tested
- Needleless jet injector, Conventional needle injection
- Keywords
- Pain score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needleless jet injectorDevice
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 injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Needleless jet injector | Experimental | Local anesthesia with needleless jet injector will be given on one site for the tooth extraction Receives: Device: Needleless jet injector |
| Conventional needle injection | Experimental | Local anesthesia with traditional needle will be given on another site for the tooth extraction Receives: Procedure: Conventional needle injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL COMPARISON OF PAIN SCORE OF NEEDLELESS JET INJECTOR AND CONVENTIONAL NEEDLE INJECTION FOR TEETH EXTRACTION ANESTHESIA (SPLIT MOUTH TECHNIQUE)
Measured: Peri operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start20 Feb 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Iftikhar, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934512
- Sponsor's protocol ID
- IRB-3820/DUHS/Approval/2025/73
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Pain Score of Needleless Jet Injector and Conventional Needle Injection for Teeth Extraction Anesthesia (Split Mouth Technique).
- ClinicalTrials.gov ID
- NCT06934512
- Acronym / sponsor ID
- IRB-3820/DUHS/Approval/2025/73
- Conditions
- Pain Score
- Keywords
- Pain score
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needleless jet injector | Experimental | Device: Needleless jet injectorLocal anesthesia with needleless jet injector will be given on one site for the tooth extraction |
| Conventional needle injection | Experimental | Procedure: Conventional needle injectionLocal anesthesia with traditional needle will be given on another site for the tooth extraction |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needleless jet injectorTo 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. | Device | Needleless jet injector |
| Conventional needle injectionTo 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. | Procedure or surgery | Conventional needle injection |
Primary outcome
CLINICAL COMPARISON OF PAIN SCORE OF NEEDLELESS JET INJECTOR AND CONVENTIONAL NEEDLE INJECTION FOR TEETH EXTRACTION ANESTHESIA (SPLIT MOUTH TECHNIQUE)
Time frame: Peri operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needleless jet injector and Conventional needle injection in people with Pain Score, run by Dow University of Health Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICAL COMPARISON OF PAIN SCORE OF NEEDLELESS JET INJECTOR AND CONVENTIONAL NEEDLE INJECTION FOR TEETH EXTRACTION ANESTHESIA (SPLIT MOUTH TECHNIQUE) (time frame: Peri operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.