Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety

NCT07045116 | Recruiting DMC

• 1 other identifier: FDASU-Rec IM012410
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes. Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars. Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS). Secondary Outcomes: Physiological markers: heart rate and oxygen saturation via pulse oximetry. Salivary amylase levels (anxiety biomarker) assessed using ELISA. Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits. Saliva samples are collected before and after each injection. Double-blind setup: children blinded using sunglasses; statistician also blinded. Same operator administers all injections for consistency. Ethical Considerations Written informed consent and assent obtained. Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring. Privacy and data security measures in place. Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05. Sample size calculated for adequate power (n = 33 minimum; 40 enrolled). Funding Self-funded. Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.

Conditions

Dental Anxiety; Pain Management

Keywords

dental anxiety; salivary amylase; dental syringes; electronic anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Perception

  Tool: Visual Analogue Scale (VAS) Scale: 0 (no pain) to 10 (worst possible pain) Purpose: To quantitatively assess the child's subjective pain level post-injection.

  Timing: Immediately after the administration of local anesthesia (both electronic and conventional)

Secondary Outcomes (3)

• Heart Rate (HR)

  Immediately before and after the administration of local anesthesia (both electronic and conventional)

• Oxygen Saturation

  Immediately before and after both the Electronic and Conventional anesthesia

• Salivary amylase level

  Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection)

Study Arms (2)

Maxillary right primary molar

ACTIVE COMPARATOR

Maxillary right primary molar will receive electronic anesthesia

Device: Electronic anesthesia

Maxillary left primary molar

ACTIVE COMPARATOR

Maxillary left primary molar will receive conventional anesthesia

Device: Conventional anesthesia

Interventions

Electronic anesthesia DEVICE

The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.

Also known as: pen injector

Maxillary right primary molar

Conventional anesthesia DEVICE

The child will receive conventional anesthesia to the maxillary left side

Also known as: Conventional syringe

Maxillary left primary molar

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year-old children.
• Medically free (ASA class I).
• Children attending their first dental visit.
• The patient should have at least one vital primary molar with deep carious lesion on each side.

You may not qualify if:

• Patient has any allergy to local anesthesia.
• Patients take any medications that affect the salivary flow.
• Patient taken corticosteroid.
• Children whose parents or legal guardians refuse to sign the informed consent.

Sponsors & Collaborators

• Randa Omer Ahmed Bashir: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reham Khaled Elghazawy, Associate professor

  Faculty of Dentistry, Ain Shams university

  STUDY DIRECTOR

• Nour Wahba, Lecturer/ Pedodontist

  Faculty of Dentistry, Ain Shams university

  STUDY DIRECTOR

Central Study Contacts

Randa Omer, Master's degree candidate

CONTACT

+201156298126; randaomar@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's degree candidate at Pediatric department, Ain Shams University

Model Details: In our dental study, the investigator will utilize a computerized system called "Sealed Envelope" to implement a random assignment of the treatment options of the participants' teeth. This randomization process is crucial to ensure that each participant receives either conventional or electronic anesthesia during their first dental treatment. While, during their second dental treatment the alternative method of anesthesia will be used. The trial is specifically constructed such that for each participant, electronic anesthetic will be applied to teeth on the right side, whereas conventional anesthesia will be used on the left side. To uphold the principles' allocation concealment, which is essential for maintaining the study's integrity. It will be kept with a third party, who will not be involved in the data collection. The allocation assignment of the participants will be requested each time a new participant is recruited in the trial.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 1, 2025
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)