Clinical trial NCT06892873: Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems
Official title: Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems in Palatal Anesthesia Applied to Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anesthesia
Keywords: Dental Anxiety
Jet Injection
Dental Injection
Pain Assessment
Palatal Infiltration Anesthesia
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Perception of Wong-Baker Scale
timeFrame: 1 minute after anesthesia application, the patient is asked to score the pain they feel.
measure: Pain Perception of The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
timeFrame: 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.
measure: Evaluation of physiological parameters with Pulse Oximetry
timeFrame: Data were recorded during applying anesthesia. Data were evaluated for up to 2 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
state: Meram
Study officials:
affiliation: halenuronat@gmail.com
name: Halenur Altan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.