Efficacy of Two Protocols for Applying Fluorine Varnish to Deciduous Teeth (CEPECO3)
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|ClinicalTrials.gov Identifier: NCT03827889|
Recruitment Status : Suspended (Outbreak of COVID-19.)
First Posted : February 4, 2019
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: WMP of fluoride varnish Procedure: TWLP of fluoride varnish Behavioral: DHP (educational intervention)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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/).
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
|Sao Paulo, Brazil, 04661100|