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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827889
Recruitment Status : Suspended (Outbreak of COVID-19.)
First Posted : February 4, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Tamara Kerber Tedesco, Universidade Ibirapuera

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

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: WMP of fluoride varnish Procedure: TWLP of fluoride varnish Behavioral: DHP (educational intervention) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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




Primary Outcome Measures :
  1. PROGRESSION OF CARIES LESIONS (caries lesions inactivation assessment) [ Time Frame: Every 6 months up to 24 months ]

    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 :
  1. Number of surfaces with NEW CARIES LESIONS [ Time Frame: Up to 24 months ]
    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.

  2. Children self-reported discomfort [ Time Frame: baseline (Immediately after procedure) ]
    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.

  3. COST-EFFICACY of each protocol [ Time Frame: up to 24 months ]
    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/).



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827889


Locations
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Brazil
Universidade Ibirapuera
Sao Paulo, Brazil, 04661100
Sponsors and Collaborators
Universidade Ibirapuera
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Responsible Party: Tamara Kerber Tedesco, PhD, Senior Lecturer, Universidade Ibirapuera
ClinicalTrials.gov Identifier: NCT03827889    
Other Study ID Numbers: UNIB5
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available on Mendeley database

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamara Kerber Tedesco, Universidade Ibirapuera:
dental caries
Tooth, Deciduous
Fluorides, Topical
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs