Pain PerceptionArabUSTNCT07257432
Electronic Anesthetic Efficacy Prof. Ali Rokia Ph.D. Al-Andalus University Prof . Mouetaz Kheirallah Ph.D ArabUST
A study testing Experimental group: Electronic syringe therapeutic intervention arm in people with Pain Perception, run by Mouetaz Kheirallah at 2 sites in Syria.
Trial summary
A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception
- What is being tested?
- Experimental group: Electronic syringe therapeutic intervention arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSyria
- Study dates
- 24 Sep 2025to 30 May 2026
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- allergic to local anesthetics ,females during menstural cycle ,bad oral care.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: a Spilt Mouth Clinical Comparative Evaluation of the Electronic Anesthetic Efficacy
A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect
Read the detailed description
Study Design:
The mouth will be split in half using a split mouth study. The lower anterior teeth will be injected with a conventional local anesthetic syringe on one side, and the patient will be injected with an electronic anesthetic syringe on the other side.
The study will be conducted on a sample of volunteers aged 18 to 30 years at the Faculty of Dentistry at Al-Andalus University.
The objectives and procedure will be explained to each group of patients, and informed consent will be obtained from each patient to accept the research procedures.
A 2% non-vasoconstrictor lidocaine local anesthetic will be used for all patients.
- Conditions
- Pain Perception
- Being tested
- Experimental group: Electronic syringe therapeutic intervention arm, control group: therapeutic intervention using a traditional syringe
- Keywords
- Dental Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: Electronic syringe therapeutic intervention armDrug
Also called anesthesia pen x
Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side
control group: therapeutic intervention using a traditional syringeDrug
Also called surgimax
During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side
| Study group | Role | What they receive |
|---|---|---|
| Electronic syringe therapeutic intervention arm | Experimental | During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side Receives: Drug: Experimental group: Electronic syringe therapeutic intervention arm; Drug: control group: therapeutic intervention using a traditional syringe |
| therapeutic intervention using a traditional syringe | Experimental | During the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side Receives: Drug: Experimental group: Electronic syringe therapeutic intervention arm; Drug: control group: therapeutic intervention using a traditional syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time
was considered as the period between the end of the injection and the first subsequent Onset time was considered as the period between the end of the injection and the first subsequent readings without response. After this period, the tooth was tested every 10 minutes until readings returned to the baseline threshold. Each subject was asked to record the time of return to normal sensation in the lower lip
Measured: 2 month
Secondary outcomes (1)
Visual Analogue Scale (VAS)
VAS uses a straight horizontal line of extent measuring 10 cm. The ends state the maximum limit of pain orientated from the best (right) to the worst (left) so that the patient can indicate the intensity of the pain (0-100). The intensity of pain is made by measuring the dimension from "no pain" to "very severe pain" based on the patient's signs
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start24 Sep 2025
- Primary completion24 Sep 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain PerceptionStudies 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
- Crossover
- Model description
- The split-mouth design was applied to the study group, with one arm for therapeutic intervention involving Smartject injection , and the other arm involving traditional injectors
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mouetaz Kheirallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mouetaz Kheirallah, Arab University for Science and Technology
- Investigators
- Ali G Rokia, ph.D, Study chair, Al-Andalus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257432
- Sponsor's protocol ID
- ArabUST
- Acronym
- ArabUST
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douglas BL. Electronic dental anesthesia. Anesth Prog. 1993;40(3):99-100. No abstract available.
PubMed 7645794
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Spilt Mouth Clinical Comparative Evaluation of the Electronic Anesthetic Efficacy
- ClinicalTrials.gov ID
- NCT07257432
- Acronym / sponsor ID
- ArabUST / ArabUST
- Conditions
- Pain Perception
- Keywords
- Dental Anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mouetaz KheirallahUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 2 Dec 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.
A Spilt Mouth Clinical Comparative Evaluation Of The Electronic Anesthetic Efficacy Comparison of traditional local anesthesia with electronic local anesthesia in terms of the ability to reduce pain during injection and the duration of the anesthetic effect
Detailed description
Study Design:
The mouth will be split in half using a split mouth study. The lower anterior teeth will be injected with a conventional local anesthetic syringe on one side, and the patient will be injected with an electronic anesthetic syringe on the other side.
The study will be conducted on a sample of volunteers aged 18 to 30 years at the Faculty of Dentistry at Al-Andalus University.
The objectives and procedure will be explained to each group of patients, and informed consent will be obtained from each patient to accept the research procedures.
A 2% non-vasoconstrictor lidocaine local anesthetic will be used for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- The split-mouth design was applied to the study group, with one arm for therapeutic intervention involving Smartject injection , and the other arm involving traditional injectors
| Arm | Type | Receives |
|---|---|---|
| Electronic syringe therapeutic intervention arm | Experimental | Drug: Experimental group: Electronic syringe therapeutic intervention arm, Drug: control group: therapeutic intervention using a traditional syringeDuring the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side |
| therapeutic intervention using a traditional syringe | Experimental | Drug: Experimental group: Electronic syringe therapeutic intervention arm, Drug: control group: therapeutic intervention using a traditional syringeDuring the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- allergic to local anesthetics ,females during menstural cycle ,bad oral care.
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 |
|---|---|---|
| Experimental group: Electronic syringe therapeutic intervention armAlso: anesthesia pen xIntraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side, while Smartject was used on the experimental side | Drug | Electronic syringe therapeutic intervention arm, therapeutic intervention using a traditional syringe |
| control group: therapeutic intervention using a traditional syringeAlso: surgimaxDuring the appointment, the subjects randomly received 1.8 ml of 2% plain lidocaine for the Intraoral Mental nerve block on both sides (experimental and control). A Carpule syringe with an aspiration and short needles 30G were used on the control side | Drug | Electronic syringe therapeutic intervention arm, therapeutic intervention using a traditional syringe |
Primary outcome
Onset time
Time frame: 2 month
was considered as the period between the end of the injection and the first subsequent Onset time was considered as the period between the end of the injection and the first subsequent readings without response. After this period, the tooth was tested every 10 minutes until readings returned to the baseline threshold. Each subject was asked to record the time of return to normal sensation in the lower lip
1 secondary outcome
Visual Analogue Scale (VAS)
Time frame: 2 month
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 2 Dec 2025.
- Background: PubMed 7645794Douglas BL. Electronic dental anesthesia. Anesth Prog. 1993;40(3):99-100. No abstract available.
- 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.
Ali G Rokia, ph.D study chair
Al-Andalus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: Electronic syringe therapeutic intervention arm in people with Pain Perception, run by Mouetaz Kheirallah at 2 sites in Syria.
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 0 inclusion and 1 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 2 Dec 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 Syria. 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?
Onset time (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07257432, which also lists 1 linked publication.
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 2 Dec 2025.