Study of the comfort of children during and after the extraction of milk teeth

Phase 4

Recruiting

• Conditions: Pain Measurement; Child; Post-Operative Pain; Injection Site Reaction; Anxiety in Dental Treatment

• Registration Number: RBR-93djd9
• Lead Sponsor: niversidade Federal de Santa Catarina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-04
• Results First Posted: 2020-08-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Children aged 4-9 years old that have clinical and radiographic indication of extraction of one erupted primary molar and who agree to participate in the research will be selected. To be included children should present good health and cooperative behavior that allow the procedure to be taken with local anesthetic.

Exclusion Criteria

The exclusion criteria are: allergies to local anesthetics or sulfites; history of significant medical conditions; taking any medications that might affect anesthetic assessment; and active state of pathosis in the area of injection.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint evaluated (1) will be pain measured by the reported pain of the transient and postoperative infantile patient after administration of analgesic prior to the primary molar extraction procedure;Primary endpoint (2) will be the anesthetic efficacy of articaine 4% with epinephrine 1: 100,000 compared to 2% lidocaine with epinephrine 1: 100,000 through vestibular infiltrative technique for primary molar extraction in patient comfort, verified by pain reported

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be children behavior during the procedure evaluated with Frankl and Venham's scale.;(b) children's anxiety before and after procedures (Facial Image Scale - FIS) and parents' anxiety before and after procedures (Dental Anxiety Scale - DAS);(c) Quality of life related to children's oral health;(d) Frequency of postoperative adverse events between local anesthetics performed with different anesthetic agents and between use of preoperative analgesic or placebo