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Comparison between two materials to stop enamel caries lesions in permanent teeth - randomized clinical trial

Comparison between ART and Silver Diamino Fluoride sealants for enamel caries lesions in permanent molars - randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-49gqnnz
Enrollment
Unknown
Registered
2024-04-03
Start date
2023-02-27
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

Randomized clinical trial, with approximately 100 children, using a total of 194 teeth, with each participant contributing an average of 2 teeth. Project carried out in municipal schools in Jordan (MG

Sponsors

Faculdade São Leopoldo Mandic
Lead Sponsor
Faculdade São Leopoldo Mandic
Collaborator

Eligibility

Age
7 Years to 13 Years

Inclusion criteria

Inclusion criteria: Children whose guardians accept and sign the TCLE (Free and Informed Consent Form); children aged 7 to 13 who allow treatment in schools; both genders; children with erupted first permanent molars or enamel carious lesions (International Caries Detection and Assessment SystemICDAS 1-3)

Exclusion criteria

Exclusion criteria: Children whose parents do not sign the consent form. Children who are absent on the day of treatment. Children who do not cooperate with treatment. Teeth with carious lesions in dentin international Caries Detection and Assessment System ICDAS 4-6. Teeth with enamel defects (amelogenesis imperfecta, hypomineralization molar-incisor, enamel hypoplasia)

Design outcomes

Primary

MeasureTime frame
Evaluate the progression of the dentin caries lesion (ICDAS 5-6) after 2 years of evaluation. Treatment efficacy will be assessed by logistic regression for the primary outcome (success/failure). Ordinal logistic regression will be used to assess patient discomfort between groups (0-5). Linear regression with bootstrap adjustment will be used to compare material costs and procedure time between groups. All analyzes will have a 95% confidence interval and adjusted according to the cluster effect (more than one tooth will be included per patient).

Secondary

MeasureTime frame
patient discomfort (Wong-Baker scale), treatment cost (material and professional in reais), treatment time and sealant survival (control group) will be evaluated.

Countries

Brazil

Contacts

Public ContactMorgana Azeredo

Faculdade São Leopoldo Mandic

morgganaazeredo@hotmail.com+55-73-982299257

Outcome results

None listed

Source: REBEC (via WHO ICTRP)