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

NCT ID: NCT07156032

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

Brief Summary

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

Detailed Description

After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.

Conditions

Pain Perception of the New Device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Starpen automatic injection device

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

Group Type: EXPERIMENTAL

Starpen automatic injection device

Intervention Type: 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

Conventional syringe

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

Group Type: ACTIVE_COMPARATOR

conventional syringe

Intervention Type: PROCEDURE

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

Interventions

Starpen automatic injection 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

Intervention Type: DEVICE

conventional syringe

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

Intervention Type: PROCEDURE

Other Intervention Names

computer controlled injection device; dental syringe

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghadeer Mohamed Sayed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SPen device injection in MPM

Identifier Type: -

Identifier Source: org_study_id