Electronic Anesthetic Efficacy Prof. Ali Rokia Ph.D. Al-Andalus University Prof . Mouetaz Kheirallah Ph.D ArabUST (ArabUST)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Perception
• Intervention / Treatment: Drug: Experimental group: Electronic syringe therapeutic intervention arm; Drug: control group: therapeutic intervention using a traditional syringe

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syria
  • Hama, Syria
    • Arab University
  • Al Kadmous
    • Tartous, Al Kadmous, Syria
      • Al Andalus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:". Age ranged from 20 to 30 years , no menstrual cycle, The participants were not allergic to local anesthetics, had not used medication that would alter pain perception, none of them had not ever experienced Smartject injection before, and none of them were alcoholics or smokers, The participants were not allergic to local anesthetics.

Exclusion Criteria:

allergic to local anesthetics ,females during menstural cycle ,bad oral care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic syringe therapeutic intervention arm; 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	Drug: Experimental group: Electronic syringe therapeutic intervention arm; 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; Other Names: anesthesia pen x; Drug: control group: therapeutic intervention using a traditional syringe; 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; Other Names: surgimax
Experimental: therapeutic intervention using a traditional syringe; 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	Drug: Experimental group: Electronic syringe therapeutic intervention arm; 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; Other Names: anesthesia pen x; Drug: control group: therapeutic intervention using a traditional syringe; 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; Other Names: surgimax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of the anesthesia	was asked to record the time of return to normal sensation in the lower lip	2 month

Collaborators and Investigators

• Sponsor: Mouetaz Kheirallah
• Investigators: Study Chair: Ali G Rokia, ph.D, Al-Andalus University

Publications and helpful links

General Publications

• Douglas BL. Electronic dental anesthesia. Anesth Prog. 1993;40(3):99-100. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Actual): September 24, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Dental Anesthesia
• Other Study ID Numbers: ArabUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No