Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth (CEPECO3)

Universidade Ibirapuera

Status: Suspended

Conditions: Dental Caries

Treatments: Behavioral: DHP (educational intervention); Procedure: WMP of fluoride varnish; Procedure: TWLP of fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT03827889

UNIB5

Details and patient eligibility

About

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

Enrollment: 168 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

WMP of fluoride varnish

Experimental group

Description:

Whole mouth protocol group

Treatment:

Procedure: WMP of fluoride varnish

TWLP of fluoride varnish

Experimental group

Description:

Tooth with lesion Protocol

Treatment:

Procedure: TWLP of fluoride varnish

DHP (educational intervention)

Active Comparator group

Description:

Diet and Hygiene guidance Protocol

Treatment:

Behavioral: DHP (educational intervention)