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

Necmettin Erbakan University

Status

Completed

Conditions

Dental Anesthesia

Treatments

Device: Comfort-In

Other: Traditional dental injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06892873

NecmettinEU04

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

4 to 11 years old

Volunteers

Accepts Healthy Volunteers

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