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

Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial

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

Study Overview

• Status: Suspended
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: WMP of fluoride varnish; Procedure: TWLP of fluoride varnish; Behavioral: DHP (educational intervention)

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04661100
    • Universidade Ibirapuera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WMP of fluoride varnish; Whole mouth protocol group	Procedure: WMP of fluoride varnish; Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
Experimental: TWLP of fluoride varnish; Tooth with lesion Protocol	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
Active Comparator: DHP (educational intervention); Diet and Hygiene guidance Protocol	Behavioral: DHP (educational intervention); The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of surfaces with NEW CARIES LESIONS	Detection of the presence of new lesions in deciduous and permanent teeth through visual inspection after dental cleaning. New lesions will be recorded using ICDAS scores.	Up to 24 months
Children self-reported discomfort	The child's discomfort will be assessed immediately after the sequence of treatments performed in each session by the Wong-Baker face scale. Each face corresponds to a number in a numeric scale from 0 to 5, being 0 no discomfort and 5 maximum of discomfort. At the end, the averages of each score will be compared between the experimental groups.The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences.	baseline (Immediately after procedure)
COST-EFFICACY of each protocol	To evaluate the cost-efficacy of different protocols by total value in dollar of treatment in relation to efficacy.The quantities of all consumables used in each procedure will be annotated, as well as the time spent in each procedure, money and time will be combined to report the cost of procedures, measured by $/hour. In addition, we will verify the efficacy through the need for new surgical treatments or new caries lesions. In this way, we will compare the experimental groups according to the cost ($/hour) x the efficacy (need for new interventions). The costs of each treatment procedure will be calculated and compared with thresholds values for intervention by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/ en/).	up to 24 months

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): July 30, 2025
• Study Completion (Anticipated): December 30, 2027

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: dental caries; Fluorides, Topical; Tooth, Deciduous
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: UNIB5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available on Mendeley database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No