NCT07257432

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025May 2026

Study Start

First participant enrolled

September 24, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

November 16, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

Dental Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual Analogue Scale (VAS)

    2 month

Other Outcomes (1)

  • duration of the anesthesia

    2 month

Study Arms (2)

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

Drug: Experimental group: Electronic syringe therapeutic intervention armDrug: 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

Drug: Experimental group: Electronic syringe therapeutic intervention armDrug: control group: therapeutic intervention using a traditional syringe

Interventions

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

Also known as: anesthesia pen x
Electronic syringe therapeutic intervention armtherapeutic 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

Also known as: surgimax
Electronic syringe therapeutic intervention armtherapeutic intervention using a traditional syringe

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al Andalus University

Tartus, Al Kadmous, Syria

Location

Arab University

Hama, Syria

Location

Related Publications (1)

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

    PMID: 7645794BACKGROUND

Study Officials

  • Ali G Rokia, ph.D

    Al-Andalus University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D., OMFS, DDS, Associate Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 2, 2025

Study Start

September 24, 2025

Primary Completion

September 24, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations