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

NCT06892873 | Completed

• 1 other identifier: NecmettinEU04
• Study Type: interventional
• Target: 76
• 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

Dental Anesthesia

Keywords

Dental Anxiety; Jet Injection; Dental Injection; Pain Assessment; Palatal Infiltration Anesthesia

Outcome Measures

Primary Outcomes (3)

• Pain Perception of Wong-Baker Scale

  The investigators expect the comfort-in jet injection method to produce a lower score on the Wong-Baker pain scale than the traditional anesthesia method.The Wong-Baker pain scale is scored between 0-10. 0 means the patient has no pain and 10 means they feel very severe pain.

  1 minute after anesthesia application, the patient is asked to score the pain they feel.

• Pain Perception of The Face, Legs, Activity, Cry, and Consolability (FLACC) scale

  The investigators expect the comfort-in jet injection method to produce a lower score on the FLACC scale applied to pain acceptance in pediatric patients compared to the traditional anesthesia method. The FLACC pain scale is scored between 0-10. 0 means that the patients pain acceptance is good and 10 means that the pain acceptance is low.

  The video was taken to examine the patient's body reactions during application of the anesthesia method. The data were evaluated up to 2 day.

• Evaluation of physiological parameters with Pulse Oximetry

  A finger-type pulse oximeter was used to measure pulse and oxygen saturation values. Data were recorded before and after anesthesia.

  Data were recorded during applying anesthesia. Data were evaluated for up to 2 days.

Study Arms (2)

Application of Traditional Dental Injection Method

ACTIVE COMPARATOR

Conventional dental injection was applied.

Other: Traditional dental injection

Application of Comfort-in Jet Injection Method

EXPERIMENTAL

Comfort-in Jet injection was applied.

Device: Comfort-In

Interventions

Comfort-In DEVICE

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.

Application of Comfort-in Jet Injection Method

Traditional dental injection 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 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.

Application of Traditional Dental Injection Method

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-11 years
• Bilateral maxillary primary molars with an indication for extraction
• Not having taken any analgesics up to 12 hours before treatment
• Not having used antibiotics in the last month
• Teeth with at most 1/2 of the root physiologically resorbed
• Systemically healthy children
• Those who agreed to participate in the study
• Those who scored 1-2-3-4 according to the Frankl behavior scale
• Frankl 1: Patients who refuse treatment, cry, are extremely fearful or show signs of severe negative behavior
• Frankl 2: Patients who are noncompliant, unwilling to receive treatment, show signs of unclear negative behavior, are sullen but do not express anxiety
• Frankl 3: Patients who accept treatment, are compliant, shy, establish a relationship with the physician but approach it moderately
• Frankl 4: Patients who cooperate with the physician, are curious about the treatment, smile and are happy with the environment (Frankl 1962)

You may not qualify if:

• If the infection has not spread beyond 1/3 of the root or furcation area
• If the root formation of the permanent tooth below is not complete or 2/3 root formation is not formed
• In the presence of dentigerous or follicular cysts
• Teeth with excessive material loss
• Teeth without permanent tooth germ underneath
• Teeth with suspected malignancy
• Children who are not systemically healthy
• Patients with a previous history of allergy to local anesthetics
• If the teeth to be extracted will require surgical extraction during the procedure
• Acute infection status (clinically, the patient has any systemic findings such as mild or severe pain, swelling, trismus, fever, lymphadenopathy, weakness, headache or nausea)
• Those who do not accept to participate in the study

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

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 BACKGROUND

Study Officials

• Halenur Altan

  halenuronat@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: March 25, 2025
• Study Start: January 22, 2024
• Primary Completion: August 30, 2024
• Study Completion: September 6, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)