Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth

NCT03827889 | Suspended

• 1 other identifier: UNIB5
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Keywords

dental caries; Tooth, Deciduous; Fluorides, Topical

Outcome Measures

Primary Outcomes (1)

• PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)

  Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as: * Present progression: Change in radiolucidity area of the Lesion * Absent progression: No change in the area of radiolucidity of the lesion.

  Every 6 months up to 24 months

Secondary Outcomes (3)

• Number of surfaces with NEW CARIES LESIONS

  Up to 24 months

• Children self-reported discomfort

  baseline (Immediately after procedure)

• COST-EFFICACY of each protocol

  up to 24 months

Study Arms (3)

WMP of fluoride varnish

EXPERIMENTAL

Whole mouth protocol group

Procedure: WMP of fluoride varnish

TWLP of fluoride varnish

EXPERIMENTAL

Tooth with lesion Protocol

Procedure: TWLP of fluoride varnish

DHP (educational intervention)

ACTIVE COMPARATOR

Diet and Hygiene guidance Protocol

Behavioral: DHP (educational intervention)

Interventions

WMP of fluoride varnish PROCEDURE

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

WMP of fluoride varnish

TWLP of fluoride varnish 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

TWLP of fluoride varnish

DHP (educational intervention) BEHAVIORAL

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

DHP (educational intervention)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Ibirapuera: lead

Study Sites (1)

Universidade Ibirapuera

São Paulo, 04661100, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 4, 2019
• Study Start: January 1, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)