Status:
COMPLETED
Clinical Evaluation and Comparison of Pain Acceptance of Different Types of Injection Systems
Lead Sponsor:
Necmettin Erbakan University
Conditions:
Dental Anesthesia
Eligibility:
All Genders
4-11 years
Phase:
NA
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 th...
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 pal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06892873
Start Date
January 22 2024
End Date
September 6 2024
Last Update
March 25 2025
Active Locations (1)
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1
Necmettin Erbakan University, Faculty of Dentistry
Konya, Meram, Turkey (Türkiye), 42090