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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

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date June 12, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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.
  • 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.
  • 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/).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth
Official Title  ICMJE Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Procedure: WMP of fluoride varnish
    Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
  • 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
  • Behavioral: DHP (educational intervention)
    The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices
Study Arms  ICMJE
  • Experimental: WMP of fluoride varnish
    Whole mouth protocol group
    Intervention: Procedure: WMP of fluoride varnish
  • Experimental: TWLP of fluoride varnish
    Tooth with lesion Protocol
    Intervention: Procedure: TWLP of fluoride varnish
  • Active Comparator: DHP (educational intervention)
    Diet and Hygiene guidance Protocol
    Intervention: Behavioral: DHP (educational intervention)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827889
Other Study ID Numbers  ICMJE UNIB5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available on Mendeley database
Responsible Party Tamara Kerber Tedesco, Universidade Ibirapuera
Study Sponsor  ICMJE Universidade Ibirapuera
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Ibirapuera
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP