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

Clinical evaluation of intraoperative pain in children undergoing preventive treatment using a new topical anesthetic photoactivated - : Anesthetics; Dental Anxiety; Sealants and Fissure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6dytyf
Enrollment
Unknown
Registered
2016-08-16
Start date
2015-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries

Interventions

Experimental group: The resin sealant will be held on 36 and 46 teeth of 80 patients. A photoactivated topical anesthetic to be used in each of these teeth will be determined by randomization via seco
Other
C07.793.720.210.220
E06.323.428

Sponsors

Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
8 Years to 12 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactAlessandra Reis

Universidade Estadual de Ponta Grossa

reis_ale@hotmail.com+55 (42) 3220 3741

Outcome results

None listed

Source: REBEC (via WHO ICTRP)