Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth

NCT ID: NCT03827889

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-12-30

Brief Summary

Evidence that the data flow analysis tests, there are still no studies that show the clarity of the protocols of its application, including the interval and execution factors of applications, concentration of fluoridation and previous prophylaxis. That is, there are still large gaps regarding fluoride varnish applications. Thus, the objective of the present project is the selection of two protocols for application of fluid applications in active drugs in primary tooth enamel. The longitudinal follow-up will be performed in a period of 3, 6, 12, 18 and 24 months after the procedure. The progression of a subject will be evaluated clinically through the transition of ICDAS scores and assessment of the lesions (sound examination with superficial measurements) by visual examination, and the physician evaluates the efficacy and the ability to evaluate the therapeutic techniques and evaluation. treatment, cost and quality of life of participants

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WMP of fluoride varnish

Whole mouth protocol group

Group Type: EXPERIMENTAL

WMP of fluoride varnish

Intervention Type: PROCEDURE

Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found

TWLP of fluoride varnish

Tooth with lesion Protocol

Group Type: EXPERIMENTAL

TWLP of fluoride varnish

Intervention Type: PROCEDURE

application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis

DHP (educational intervention)

Diet and Hygiene guidance Protocol

Group Type: ACTIVE_COMPARATOR

DHP (educational intervention)

Intervention Type: BEHAVIORAL

The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices

Interventions

WMP of fluoride varnish

Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found

Intervention Type: PROCEDURE

TWLP of fluoride varnish

application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis

Intervention Type: PROCEDURE

DHP (educational intervention)

The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children with active carious lesions scores 1, 2 or 3 of the ICDAS in deciduous teeth

Exclusion Criteria

• Patients with special needs;
• Patients using orthodontic appliances;
• systemic diseases;
• Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp involvement, fistulae and / or abscesses;
• teeth with spontaneous painful symptomatology.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Ibirapuera

OTHER

Sponsor Role: lead

Responsible Party

Tamara Kerber Tedesco

PhD, Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Ibirapuera

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

UNIB5

Identifier Type: -

Identifier Source: org_study_id