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

NCT06606587 | Completed Results FDA Device

• 1 other identifier: NecmettinEU02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physiological Effects of Drugs; Anesthetics

Keywords

Comfort-In; Dental anxiety; Needle-free injection; Palatal infiltrative anesthesia

Outcome Measures

Primary Outcomes (2)

• Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale

  Pain perception was assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.

  Immediately after the anesthesia is administered

• Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale

  Pain perception was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. Higher scores indicate worse outcomes (greater pain intensity). Behavioral responses during the injection were video-recorded and later evaluated.

  During the administration of the palatal anesthesia injection.

Study Arms (2)

Group Experimental: Application of Comfort-in Jet Injection Method

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. 25 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.

Device: Comfort-in Jet Injection Method

Group Control: Application of Traditional Dental Injection Method

OTHER

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.

Other: Traditional Dental Injection

Interventions

Comfort-in Jet Injection Method DEVICE

Application of Comfort-in Jet Injection Method: Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar.

Group Experimental: Application of Comfort-in Jet Injection Method

Traditional Dental Injection OTHER

Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.

Group Control: Application of Traditional Dental Injection Method

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease

You may not qualify if:

• If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

: Halenur Altan, assoc. prof.

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

• Altan H, Belevcikli M, Cosgun A, Demir O. Comparative evaluation of pain perception with a new needle-free system and dental needle method in children: a randomized clinical trial. BMC Anesthesiol. 2021 Dec 1;21(1):301. doi: 10.1186/s12871-021-01524-1.

  PMID: 34852779 RESULT

Results Point of Contact

• Title: Büşra Almas
• Organization: Necmettin Erbakan University, Faculty of Dentistry, Department of Pediatric Dentistry

balmas48@gmail.com

+905445598508

Study Officials

• Halenur Altan

  Necmetttin Erbakan University Dentistry Faculty

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: When giving data to the statistician, he will not be told which group the data is in. The data will be changed to a and b to try to prevent bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Participants meeting the inclusion criteria were randomly assigned to one of two groups. To ensure randomization, two sealed envelopes, each containing one of the anesthesia methods, were prepared. One envelope contained "Group 1" and the other contained "Group 2". Each participant selected an envelope, determining their assigned anesthesia technique. In Group 1, palatal anesthesia was administered using the Comfort-In™ jet injection system, while in Group 2, a dental needle injection was used.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: September 23, 2024
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)