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

NCT ID: NCT06606587

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

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.

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

Study Design

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

Study Groups

Group Experimental: Application of 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. 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.

Group Type: EXPERIMENTAL

Comfort-in Jet Injection Method

Intervention Type: DEVICE

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

Group Control: Application of Traditional Dental Injection Method

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 Type: OTHER

Traditional Dental Injection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Traditional Dental Injection

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Halenur Altan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Halenur Altan

Role: STUDY_CHAIR

Necmetttin Erbakan University Dentistry Faculty

Locations

: Halenur Altan, assoc. prof.

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 34852779 (View on PubMed)

Other Identifiers

NecmettinEU02

Identifier Type: -

Identifier Source: org_study_id