Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars

NCT07156032 | Not Yet Recruiting DMC

• 1 other identifier: SPen device injection in MPM
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.

Conditions

Pain Perception of the New Device

Keywords

Starpen device; Computer controlled automatic injection device; Computer controlled injection; pain perception; infiltration anesthesia; extraction of maxillary primary molars

Outcome Measures

Primary Outcomes (1)

• Subjective pain during injection

  Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.

  during procedure

Secondary Outcomes (5)

• Objective pain during infiltration

  during procedure

• Subjective pain during extraction

  during procedure

• Objective pain during extraction

  during procedure

• Physiological parameters ( heart rate )

  Readings will be taken before and during anesthesia injection and during extraction.

• Physiological parameter ( oxygen saturation)

  Readings will be taken before and during anesthesia injection and during extraction.

Study Arms (2)

Starpen automatic injection device

EXPERIMENTAL

effect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars

Device: Starpen automatic injection device

Conventional syringe

ACTIVE COMPARATOR

Conventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars

Procedure: conventional syringe

Interventions

Starpen automatic injection device DEVICE

Starpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle

Also known as: computer controlled injection device

Starpen automatic injection device

conventional syringe PROCEDURE

injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle

Also known as: dental syringe

Conventional syringe

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-8 years
• Cooperative children ( rating 3 or 4 based on the Frankl behavior scale )
• Medically fit children (ASA I )
• Children mentally capable of communication
• First dental visit
• Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies
• No acute dental pain

You may not qualify if:

• Children with a behavioral management problem
• Parental refusal of participation
• Children with previous history of local anesthesia injection
• Medically unfit children (other than ASA I )
• Uncooperative children ( other than Frankl 3,4)
• Children under medications ( antibiotics and analgesics ) for the previous 48 hours that could alter the pain perception
• Teeth that showed any signs of mobility , ankylosis or root resorption affecting more than one third the root
• Acute dental pain

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share