NCT06606587

Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia

Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is: Is the needle-free injection method more painless than the traditional dental method? Two different methods will be used for children to perform anesthesia for extraction permanent molars.

Detailed description

Study Groups and Study Design: 56 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study. Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study. For randomization, methods were written on two different envelopes and the child was allowed to choose the envelope. The child was assigned to the selected method. Group Control: Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin\*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Group Experimental: Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 31 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed.

Conditions

• Physiological Effects of Drugs
• Anesthetics

Interventions

Type	Name	Description
DEVICE	Comfort-in Jet Injection Method	Application of Comfort-in Jet Injection Method: Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar.
OTHER	Traditional Dental Injection	Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2024-09-23
• Last updated: 2025-05-22

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study