NCT05443009

Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Universidade Federal de Santa Catarina · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.

Detailed description

In the present study, self-reported pain during extraction of a maxillary primary molar with one buccal infiltration anesthesia with articaine will be compared with the conventional technique (buccal infiltration and palatal supplementation) with lidocaine. The study design will be a blind, controlled, randomized, non-inferiority clinical trial with two parallel groups. The anesthetic will be administered according to the weight of the child, using a table with the amount of anesthetic per weight group and the maximum recommended dose as reference. The hypothesis is that articaine, due to its anesthetic properties, is able to anesthetize as well as lidocaine with only one oral infiltration, without the need for additional anesthesia, which may guarantee better participant comfort, less dental anxiety, and less chair time. The use of the Visual Analogue Scale is important to assess the pain perceived by the children and to ensure the reliability of the responses. Participant comfort will be evaluated at each stage of the proposed treatment, and withdrawal from participation will be guaranteed at any time.

Conditions

• Dental Pain
• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Lidocaine	A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.
DRUG	Articaine	A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.

Timeline

• Start date: 2022-06-30
• Primary completion: 2024-07-04
• Completion: 2024-11-21
• First posted: 2022-07-05
• Last updated: 2024-11-25

Locations

4 sites across 1 country: Brazil