NCT06892873

Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems

Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems in Palatal Anesthesia Applied to Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 4 Years – 11 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

The reason for wanting to conduct this research is that palatal injection, which is routinely used in the extraction of primary molars, causes pain and fear due to the tight connection between the palatal mucosa and the bone, and causes difficulty in tolerating it by pediatric patients. The aim of our research is to evaluate whether Comfort-in™ Needle-Free Injection, which can be used during palatal injection, can reduce injection pain. The palate side of the upper primary molars that require extraction treatment will be anesthetized with two different anesthesia techniques. One of these techniques will be applied with a needle and the other without a needle. The technique will be decided by determining which technique will be applied first using a random computer program. A 'popcorn sound' may occur during needle-free anesthesia, the investigators wanted to inform participants in advance so that participants are not surprised. The investigators also want to apply a scale called IDAF-4C to participants in order to learn the level of participants' concerns and fears about dentistry. The investigators plan to ask participants about this scale when participants first come to the clinic. After anesthetizing participants' teeth, the investigators will ask participants to evaluate the severity of pain with the Wong-Baker Pain Rating Scale. During female anesthesia, body responses will be recorded via video and then evaluated with the FLACC scale.

Conditions

• Dental Anesthesia

Interventions

Type	Name	Description
DEVICE	Comfort-In	Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the primary molars. The device was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.2 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. 38 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.
OTHER	Traditional dental injection	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 mL of anesthetic solution was stored when bone contact was removed. 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. 38 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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-08-30
• Completion: 2024-09-06
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Turkey (Türkiye)