Clinical research of pain during treatment sealants in children using a new topical anesthetic photoactivated

Not Applicable

• Conditions: E06.323.428; E03.155.141; C10.597.617; D25.339.773; Dental caries; Dental Restoration, Permanent; Anesthesia, Dental; Pain; Dental Anxiety; Pit and Fissure Sealants

• Registration Number: RBR-6dytyf
• Lead Sponsor: niversidade Estadual de Ponta Grossa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Children 8 to 12 years with good general and oral health; the teeth 36 and 46 should be fully erupted and have sealant indication.

Exclusion Criteria

Teeth that are unerupted or carious lesions that require restoration; also a history of allergy patients are excluded; any form of sensitivity or allergic reaction to anesthetics and ester-based components of the formula; severe systemic disease patients not controlled as heart problems; neurological; kidney; liver or blood and even patients not employees.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome: Number of patients reporting pain during the placement of a staple for absolute isolation after application of a topical anesthetic photoactivated through self-report. This number will be transformed into percentage of patients with pain and is called absolute risk of pain.

Secondary Outcome Measures

Name	Time	Method
Expected outcome: The intensity of the pain will be assessed by scale of facial expression Wong-Baker (0-5) and a numeric scale of 11 points (0-10) and will be presented as mean and standard deviation.;Expected outcome: The pain of the risk will be assessed by dichotomous scale (yes or no) and will be presented as mean and standard deviation.