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Search / Trial NCT06892873

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

Launched by NECMETTIN ERBAKAN UNIVERSITY · Mar 21, 2025

Trial Information

Current as of April 23, 2025

Completed

Keywords

Dental Anxiety Jet Injection Dental Injection Pain Assessment Palatal Infiltration Anesthesia

ClinConnect Summary

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 te...

Gender

ALL

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

Trial Officials

Halenur Altan

Principal Investigator

halenuronat@gmail.com

About Necmettin Erbakan University

Necmettin Erbakan University is a prominent academic institution dedicated to advancing health sciences and research through innovative clinical trials. With a commitment to excellence in education and research, the university leverages its multidisciplinary approach to foster collaborations that enhance patient care and medical advancements. By conducting rigorous clinical studies, Necmettin Erbakan University seeks to contribute valuable insights to the medical community, ultimately improving treatment outcomes and fostering evidence-based practices in healthcare.

Locations

Konya, Meram, Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported