NCT07156032

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

Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-09-04
• Last updated: 2025-09-04