ClinicalTrials.gg
RecruitingNCT07915531Updated Nov 4, 2026

Pain Perception With Cordless Electronic Local Anesthetic Delivery System

An interventional study of Cordless Electronic local anesthetic delivery system and Conventional dental syringe in Decayed Primary Molars, sponsored by National Research Centre, Egypt. Recruiting at 1 site in Egypt. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by National Research Centre, Egypt · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

22 children with two primary molars that need extraction or pulpotomy will be selected to compare pain perception between conventional dental syringe and cordless electronic local anesthetic delivery system.

Read the detailed description

This is a split mouth randomized controlled trial, will be conducted in the outpatient clinic of pediatric dentistry, Medical and scientific Centre of Excellence, National Research Centre. and who have two primary molars that are indicated for pulpotomies or extractions. The study's protocol, risks, and benefits will be explained to the parents or legal guardians, and informed consent will be obtained from them if they agree to participate.

Clinical procedure:

  1. Explaining clinical procedure and the objectives of the study to parents or Guardians and obtaining an informed consent from them. the research will be conducted in conformity with the Declaration of Helsinki (2013).
  2. All children will be clinically examined and randomly assigned to one of the LA techniques (traditional or Star pen®) in the first appointment.
  3. Subjective evaluation of dental fear and anxiety of each child using The Dental Subscale of Children's Fear Survey Schedule (CFSS-DS) (Mobin et al., 2023)Prior any treatment.
  4. Subjective evaluation of pain perception will be evaluated for each child immediately post injection using Wong-Baker FACES Pain Rating Scale (WBFPRS) (Garra et al., 2010).
  5. Objective evaluation of pain behavior will be evaluated for each child during injection using FLACC Scale (Face, Legs, Activity, Cry, and Consolability) (Nagarwal et al., 2022).
  6. Physiological parameters of pain assessment such as Heart Rate and Oxygen saturation will be measured using pulse oximeter at pre-injection and during injection.
  7. Finishing the dental treatment either extraction or pulp therapy.

Statistical analysis:

Statistical analysis will be performed using a commercially available software program (SPSS Chicago, IL, USA).

Numerical data will be described as mean and standard deviation or as median and range as appropriate according to the normality of the data. Data will be compared using Mann Whitney U test or independent t test depending on normality.

The level of significance will be set at P≤0.05. All tests will be two tailed.

02

Conditions studied

  • Decayed Primary Molars

Keywords

  • CCLAD- Pain perception- Pain behavior- dental anesthesia- dental anxiety
03

In context

Lead sponsor

National Research Centre, Egypt is the lead sponsor of 51 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Physically and mentally healthy children with no cognitive or emotional impairments.
  • Having two contralateral primary molars need extraction or pulpotomy.
  • No for the use of local anesthesia.
  • Not taking any analgesic before the appointment for at least 24

Exclusion criteria

Exclusion Criteria:

  • History of allergy to local anesthetics
  • acute infection or inflammation at the injection site,
  • significant cognitive or developmental impairments that prevent reliable pain assessment
  • use of analgesics or sedatives within 24 hours of the procedure.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Cordless Electronic Local anesthetic delivery system

    Device: Cordless Electronic local anesthetic delivery system

  • Active comparator
    Conventional dental Syringe

    Device: Conventional dental syringe

Interventions

  • DeviceCordless Electronic local anesthetic delivery system

    Wireless computer-controlled local anesthetic delivery (CCLADs) (Star Pen)with the control unit integrated into the syringe body, eliminating the need for foot pedal attachments. it uses use conventional dental needles and LA carpules

  • DeviceConventional dental syringe

    The injection of a local anesthetic using conventional dental syringe

06

What researchers measure

Primary outcomes

  1. Pain perception

    assessment of pain perception between the two devices using Wong-Baker FACES Pain Rating Scale (WBFPRS), it consists of 6 faces with word descriptors and numbers from 0 to 10. The child is asked to point to the face that describes how he/she feels at the particular moment and numbers on this scale can be adjusted to a 0 to 10 Also FLACC Scale (Face, Legs, Activity, Cry, and Consolability) is used to assess behavioral pain of the child, it has scores from 0 to 2.

    Time frame: perioperative

Secondary outcomes

  1. Dental fear and anxiety

    correlation between dental fear and anxiety and pain perception using Dental Subscale of Children's Fear Survey Schedule (CFSS-DS)

    Time frame: perioperative

07

Study locations

1 of 1 sites recruiting
  • National Research Centre
    Giza, Egypt
    Recruiting
    • National research centre NRC · Contactinfo@nrc.sci.eg · 002+ 0233371615
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07915531
Lead sponsor
National Research Centre, Egypt
Responsible party
Eman Ahmed Mohamed Korayem (Researcher, National Research Centre, Egypt) — Principal investigator
First posted
Nov 4, 2026
Start date
Aug 10, 2026
Primary completion
Nov 10, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Nov 4, 2026

Study contacts

Eman A Korayem, Researcher
Contact
ea.korayem@nrc.sci.eg
002+ 01282527959
Mohamed F Rashed, Researcher
Contact
drmfarouk@yahoo.com
002+01096546623

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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