Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection

NCT07688018 | Completed DMC

• 1 other identifier: 460 - 6/01/2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pain and anxiety management during injection of local anesthesia are major challenges in pediatric dentistry. The injection of local anesthesia is often perceived by children as the most painful step , The introduction of computerized control local anesthetic delivery systems (CCLADS), such as the Star Pen device, has provided a modern approach for reducing discomfort during anesthesia. Additionally, the integrated music distraction feature enhances relaxation and cooperation during treatment.

Conditions

Computer-controlled Local Anesthesia

Keywords

Behavior management; Pediatric dentistry;

Outcome Measures

Primary Outcomes (2)

• heart rate

  measuring heart rate by pulse oximeter

  The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.

• Sound, Eye, Motor (SEM) Scale

  objective method for pain assessment during LA administration scores from 1--\>4 score 1=comfort(low score) score 4=severe discomfort (high score)

  will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.

Study Arms (2)

Mandibular (IANB)

EXPERIMENTAL

Mandibular (IANB)

Device: star pen; Device: Conventional 4% articaine delivery by carpule syringe

Maxillary Infiltration

EXPERIMENTAL

Maxillary Infiltration

Device: star pen; Device: Conventional 4% articaine delivery by carpule syringe

Interventions

star pen DEVICE

CCLADS

Mandibular (IANB); Maxillary Infiltration

Conventional 4% articaine delivery by carpule syringe DEVICE

infiltration or inferior alveolar local anesthesia

Mandibular (IANB); Maxillary Infiltration

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Completion of the written informed consent form by parents/guardian.
• Children aged between 4 and 6 years.
• Medically fit patients classified as (ASA I).
• Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4.
• Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD).

You may not qualify if:

• Children with a history of allergy to local anaesthetic agents.
• Children who receive any analgesic drugs at least 24 h before treatment.
• Any inflammation or lesion in the injection site.
• Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences.
• Child coming for emergency treatment of pain.
• Teeth with ankylosed roots.

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Sites (1)

Pharos university in Alexandria

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

EG (1)