Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy TreatmentNCT07095946
Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe
A study testing Electronic Syringe Intraligament Technique and Electronic syringe IANB Technique in people with Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy Treatment, run by Latakia University at 1 site in Syria.
Trial summary
This randomized clinical study aims to evaluate the efficacy and pain response of two local anesthesia techniques in pediatric dental treatment using an electronic syringe: ligament anesthesia and inferior alveolar nerve block (IANB). Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy Treatment
- What is being tested?
- Electronic Syringe Intraligament Technique and Electronic syringe IANB Technique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 28 May 2025to 20 Apr 2026
- Phase
- Interventional
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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children based on Frankl Behavior Rating Scale (Positive or Definitely Positive)
- No clinical signs or symptoms indicating irreversible pulpitis
- No periodontal ligament inflammation of the tooth to be treated
- Children aged between 5 and 9 years
- Children without systemic health problems
Who cannot join
- Children who are uncooperative based on Frankl Behavior Rating Scale (Negative or Definitely Negative)
- Presence of spontaneous or nocturnal pain
- Clinical signs and symptoms indicating irreversible pulpitis
- Presence of periodontal ligament inflammation of the treated tooth
- Child age older than 10 years or younger than 3 years
- Children with systemic health problems
Trial locations and contacts
1 site in 1 country.
Syria1 site
Faculty of Pediatric Dentistry, Tishreen University
Latakia, Latakia Governorate
About this study
Official title: Comparing the Effectiveness of the Intraligament Anesthesia Technique With the Inferior Alveolar Nerve Block Technique Using the Electronic Syringe in Children: A Random Clinical Study
This randomized clinical study aims to evaluate the efficacy and pain response of two local anesthesia techniques in pediatric dental treatment using an electronic syringe: ligament anesthesia and inferior alveolar nerve block (IANB). The study applies both techniques to the same sample, where each child undergoes pulpectomy for two different teeth, each under the influence of a different anesthesia technique, during two separate visits.
This study comes in the context of technological advancements in dentistry, which led to the development of computerized syringes as an alternative to traditional syringes. These devices are characterized by precise control of the anesthetic flow rate, as well as containing musical and auditory systems aimed at distracting the child and reducing feelings of fear and anxiety associated with dental treatment. Additionally, computerized syringes provide audible indicators showing the amount of anesthetic injected and support multiple injection modes such as rapid injection, slow injection, and ligament injection, allowing for more efficient and comfortable anesthetic delivery.
Pain intensity will be assessed during three stages of the treatment procedure: during anesthesia administration, during placement of the rubber dam, and during opening of the pulp chambers. Post-procedure pain will also be evaluated using an age-appropriate validated pain scale, along with assessing the satisfaction level of both the children and their parents regarding the use of the electronic syringe as an alternative anesthesia tool. These combined measures aim to provide a comprehensive understanding of the child's experience during dental treatment and contribute to improving anesthesia practices in pediatric dentistry.
- Being tested
- Electronic Syringe Intraligament Technique, Electronic syringe IANB Technique
- Keywords
- Pediatric Dental Anesthesia Pulpitis Pain Management in Pediatric Dentistry Primary Teeth Endodontic Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Syringe Intraligament TechniqueDevice
Use of an electronic syringe device to deliver local anesthesia using the periodontal ligament (PDL) technique in pediatric dental patients
Electronic syringe IANB TechniqueDevice
Use of an electronic syringe device to deliver local anesthesia via the Inferior Alveolar Nerve Block Technique in pediatric dental patients
| Study group | Role | What they receive |
|---|---|---|
| Electronic Syringe - IANB Technique | Experimental | Children receive inferior alveolar nerve block (IANB) using an electronic syringe. The injection is performed with controlled speed and pressure to ensure efficient pulpal anesthesia with minimal discomfort. Receives: Device: Electronic syringe IANB Technique |
| Electronic Syringe - Intraligamentary Technique | Experimental | Children receive intraligamentary anesthesia using an electronic syringe. The anesthetic is administered around the tooth ligament to provide localized anesthesia with minimal invasiveness and reduced discomfort. Receives: Device: Electronic Syringe Intraligament Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of electronic syringe anesthesia in pediatric dental procedures
Measured: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening)
Success rate of anesthesia technique
Measured: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start28 May 2025
- Primary completion20 Sep 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy TreatmentStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Wahab Nourallah, Prof.Dr, Study chair, Faculty of Pediatric Dentistry,Tishreen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095946
- Sponsor's protocol ID
- PED-DENT-Tishreen-University
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of pediatric patients.