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Clinical trial

Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient

ID
Name
26379996/10
Description
The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.
Trial arms
Trial start
2023-05-02
Estimated PCD
2023-08-28
Trial end
2023-09-05
Status
Recruiting
Treatment
Articaine Hydrochloride + Epinephrine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction. Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction.
Arms:
Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl), Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl), Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
Other names:
ultracaine ds
Lidocaine Hydrochloride + Epinephrine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group
Arms:
Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl), Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl), Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
Other names:
jetocaine
Size
96
Primary endpoint
Evaluation of pain during tooth extraction after anesthesia with VAS
baseline and maximum 8 minutes
Evaluation of pain during tooth extraction after anesthesia with Wong-Baker
baseline and maximum 8 minutes
Eligibility criteria
Inclusion Criteria: * The child has no systemic disease * Absence of acute toothache * Child's first tooth extraction treatment * No suspected allergy to benzocaine, lidocaine or articaine * Comply with Frankl's 3 or Frankl's 4 behavioral assessments Exclusion Criteria: * Patients who do not want to participate in the study * Any systemic condition * Patients with any drug or local anesthetic allergy * Patient has acute toothache or abscess * Patients with previous tooth extraction experience * Frankl 1 and Frankl 2 patients
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Day', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}
Updated at
2023-09-06

1 organization

2 products

1 indication

Organization
Ankara Yildirim Beyazıt University
Product
Articaine Hydrochloride + Epinephrine
Indication
Local Anesthetic Complication
Product
Lidocaine + Epinephrine