Effect of Carvacrol and Thymol against dental caries in childre

Not Applicable

Completed

• Conditions: Early childhood caries; Oral Health; Dental caries

• Registration Number: ISRCTN27780232
• Lead Sponsor: Federal University of Ceará - Comitê de Ética em Pesquisa - UFC/PROPESQ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-02-01
• Study Start: 2018-07-20
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Aged 36–71 months
2. Caries-free children without past caries
3. At a high-risk category for dental caries according to the 2010 guidelines of the American Academy of Pediatric Dentistry
4. Enrolled in schools and preschools in the city of Fortaleza (Brazil)

Exclusion Criteria

1. History of allergic diseases (asthma, rhinitis, sinusitis, skin rash)
2. History of allergies to medications and food
3. Aphthous ulcers or lesions affecting the oral mucosa
4. Taking antibiotics during the study period
5. Parents or legal guardians refused to sign the informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dental caries assessed by dental examinations performed by a single examiner during a 12-month period. These examinations were carried out before beginning of treatment, and 7, 30, 90, 180 and 360 days after initiation of treatment. In order to minimize the diagnostic bias between groups, a calibration of the examiner was performed, according to criteria recommended by the World Health Organization (1993). A mean Kappa of 0.83 was obtained, that is considered a good or excellent intra-examiner agreement level (Eklund, Moller, Leclerq, 1996).