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

Primary Purpose

Dental Caries

Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
WMP of fluoride varnish
TWLP of fluoride varnish
DHP (educational intervention)
Sponsored by
Universidade Ibirapuera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring dental caries, Tooth, Deciduous, Fluorides, Topical

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Universidade Ibirapuera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

WMP of fluoride varnish

TWLP of fluoride varnish

DHP (educational intervention)

Arm Description

Whole mouth protocol group

Tooth with lesion Protocol

Diet and Hygiene guidance Protocol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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/).

Full Information

First Posted
January 22, 2019
Last Updated
May 8, 2023
Sponsor
Universidade Ibirapuera
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1. Study Identification

Unique Protocol Identification Number
NCT03827889
Brief Title
Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth
Acronym
CEPECO3
Official Title
Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
Outbreak of COVID-19.
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Ibirapuera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, Tooth, Deciduous, Fluorides, Topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WMP of fluoride varnish
Arm Type
Experimental
Arm Description
Whole mouth protocol group
Arm Title
TWLP of fluoride varnish
Arm Type
Experimental
Arm Description
Tooth with lesion Protocol
Arm Title
DHP (educational intervention)
Arm Type
Active Comparator
Arm Description
Diet and Hygiene guidance Protocol
Intervention Type
Procedure
Intervention Name(s)
WMP of fluoride varnish
Intervention Description
Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
Intervention Type
Procedure
Intervention Name(s)
TWLP of fluoride varnish
Intervention Description
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
Behavioral
Intervention Name(s)
DHP (educational intervention)
Intervention Description
The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices
Primary Outcome Measure Information:
Title
PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment)
Description
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.
Time Frame
Every 6 months up to 24 months
Secondary Outcome Measure Information:
Title
Number of surfaces with NEW CARIES LESIONS
Description
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.
Time Frame
Up to 24 months
Title
Children self-reported discomfort
Description
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.
Time Frame
baseline (Immediately after procedure)
Title
COST-EFFICACY of each protocol
Description
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/).
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Universidade Ibirapuera
City
Sao Paulo
ZIP/Postal Code
04661100
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available on Mendeley database

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Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth

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