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Efficacy of Occlusal Sealants on permanent molars using two bioactive materials: a two-year follow-up clinical trial

Efficacy of Occlusal Sealants on permanent molars using two categories of bioactive materials: a two-year follow-up double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-107zc6gt
Enrollment
Unknown
Registered
2023-04-14
Start date
2023-05-01
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

Control: 84 participants aged 6 to 8 years will receive high viscosity resin-modified ionomeric sealant encapsulated in all molars with indication for occlusal sealant (ICDAS 0 with risk of developing

Sponsors

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

Eligibility

Age
6 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children of both sexes; age between 6 to 8 years; who will voluntarily present themselves for dental care at the Children's Dental Clinics of UEPG and at the Center for Integral Attention to Children and Adolescents (CAIC UEPG), as well as at Municipal Schools in the municipality of Ponta Grossa; with the presence of permanent molars with indication for the application of preventive sealants (ICDAS 0, but with risk of developing carious lesions) or therapeutic sealants (with the presence of incipient carious lesions ICDAS 1, 2 and 3); who are accompanied by their parents/guardians and/or with the TCLE and TALE duly signed

Exclusion criteria

Exclusion criteria: Children residing in rural areas and/or places where there is no supply of fluoridated water; do not show favorable behavior; are not in good general health and/or have any physical, mental, visual or hearing impairment; are allergic to any of the materials used in the research (latex); use orthodontic appliance in the period stipulated by the survey; have unfavorable oral conditions (presence of abscess, fistula, residual root, intense caries activity)

Design outcomes

Primary

MeasureTime frame
It is expected that the products used in the research are effective in stopping the evolution of carious lesions, determined through the tactile-visual method, using the OMS probe to evaluate the texture of the enamel (smooth: inactive lesion or rough: active lesion), clinical mirror to assess appearance (glossy: inactive lesion or dull: active lesion) and artificial light, at baseline and at biannual study evaluations (at 6, 12, 18, and 24 months)

Secondary

MeasureTime frame
It is expected that there will be some percentage of partial or total loss to the naked eye of both materials used in the research until the end of the evaluations, determined through visual examination, clinical mirror and artificial light. Each molar that underwent intervention will be classified according to the clinical evaluation criteria proposed by the FDI for functional properties, with scores from 1 to 5 being attributed. addition, it is expected that the images obtained show that the bottom of the pits and fissures are filled with the materials tested in this research. Data collected before the intervention, after the intervention and at the six-monthly evaluations (at 6, 12, 18 and 24 months)

Countries

Brazil

Contacts

Public ContactDenise Wambier

Universidade Estadual de Ponta Grossa

dswambier@hotmail.com+55(42)32203104

Outcome results

None listed

Source: REBEC (via WHO ICTRP)