Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

NCT07101068 | Recruiting DMC

• 1 other identifier: FDSU-Rec IMO12441
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.

Conditions

Dental Caries; Reversible Pulpitis

Keywords

Pediatric Dentistry; Local Anesthesia; Dental Anesthesia Injector; Conventional Syringe; Pain Assessment; Vasual Analogue Scale; Corah Dental Anxiety Scale; Pulse Oximeter; Split-mouth Design; Reversible Pulpitis

Outcome Measures

Primary Outcomes (2)

• Pain during injection

  The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) } Pulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety

  The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.

• Anxiety felt by the patient

  Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions \<9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.

  the scale will be used at day 1 of anesthesia injection

Secondary Outcomes (1)

• Need for additional anesthesia

  The assessment will be done during dental visit at day 1 of anesthesia injection

Study Arms (2)

Dental Anesthesia Injector

EXPERIMENTAL

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia injector .

Device: Dental Anesthesia Injector

Conventional syringe

ACTIVE COMPARATOR

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Other: conventional syringe

Interventions

Dental Anesthesia Injector DEVICE

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.

Dental Anesthesia Injector

conventional syringe OTHER

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe

Conventional syringe

Eligibility Criteria

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

You may qualify if:

• normal healthy patients (ASA I)
• Undergoing the first dental local anesthesia experience
• Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
• Score 3 or 4 of Frankl scale of child behavior

You may not qualify if:

• Presence of gingivitis, dental abscess, facial trauma/ injury
• Administration of analgesic 48 h before randomization
• Presence of allergy from local anesthesia

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Faculty of dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (1)

• Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.

  PMID: 36627224 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Sarah Mohamed Shafik, Associate Professor

  Pediatric Dentistry department, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Samaa Abdo Mahmoud, Demonstrator

CONTACT

201023004597; samaa.abdo@dent.asu.edu.eg

Samaa Mahmoud Abd El Saeed, Demonstrator

CONTACT

201032291056; samaaabdo95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized, split-mouth clinical trial uses a computerized randomization system (Sealed Envelope) to allocate the two interventions: conventional anesthesia and Dental Anesthesia Injector. For each participant, one side of the mouth will receive local anesthesia via the Dental Anesthesia Injector, while the other side will receive the conventional anesthesia method. The randomization process ensures that the assignment of anesthesia methods to the right or left side is random for each participant. Allocation concealment is maintained by a third party who is not involved in data collection and manages the allocation assignments for each new participant

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: August 3, 2025
• Study Start: January 25, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)