Evaluation in Vivo of Mouthwash With Nanoencapsulated Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The literature recognizes that fluoride is the most widely used and studied means for dental
      remineralization. The use of fluoride mouthwashes is shown as an effective way to increase
      the fluoride intraoral availability. However, the current challenge is the substantivity, so
      new compounds have been introduced into these formulations. This study aims to evaluate the
      in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - in
      fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type,
      crossover, double-blind, randomized will be held. After sample calculation, the total of 12
      individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth
      index less than 6 and residents in brazilian northeast capital will be part of the sample.
      Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of
      fluoridated weekly. The biofilm will be assessed on 1h and 12 h after rinsing; and
      unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3
      mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium
      fluoride. Between weeks of use, rinsing will be extended washout (without fluoride) to avoid
      carryover effect. Inferential data analysis will be carried out, considering the amount of
      alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in
      the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re
      process and in the control of dental caries.
    

Detailed description: 
      1. Study design It is a quantitative study of double-blind randomized crossover clinical
           type with inductive approach and documentation of technical and direct observation with
           measurements in the laboratory.

           In order to assess the bioavailability of intraoral fluoride week after the use of
           fluoride mouthwashes containing Nanoencapsulated Fluoride, it will be collected biofilm
           samples 1h and 12 h after rinse; and unstimulated saliva in times of 3, 15, 30, 45, 60
           minutes and 12 hours after. The data will be obtained by physical and chemical analysis
           of the samples of fluoride (F). Therefore, the study will consist of two interrelated
           steps: a clinical phase for biofilm collection and saliva; and laboratory stage for
           fluoride analysis in the samples.

           Will be conducted pilot test with three participants before the start of the study.

        2. Sample Size The sample size calculation was performed using fluoride concentration data
           in dental biofilm previous study and taking effect size difference between the
           experimental mouthwash (100% Nanoencapsulated Fluoride ) and positive control of at
           least 3.4 ppm of F- in biofilm after 12 hours, namely, 25%. Admitting experimental
           protocol with beta error of 10% alpha error of 5%, one-tailed and statistical power of
           90%, the sample size was calculated for 6 people. For the calculation we used the Excel
           software and mathematical formula for clinical trials of superiority given. Adding
           sample loss resulted in 12 people.

        3. Experimental Mouthwash For this study will be used four mouthwashes: 50%
           Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride, Free sodium fluoride, Without
           fluoride. The mouthwash, made available by the company from Brazil are packed in the
           same packaging and have the taste of mint. Except wash out the packing with mouthwash
           will be identified by letters (A, B and C) by an independent researcher. The letters
           code will not be revealed to the participants nor the researcher who will accompany
           them. These will be drawn at random for daily use for seven days in four times, giving
           an interval of one week wash-out between them.

           In these periods of wash-out will use a mouthwash without fluoride. In the end, all
           study participants will use the 5 experimental mouthwash at different times. A
           dentifrice without fluoride will be used by the participant during the study.

        4. Clinical phase The participant will be informed about the study and after its
           acceptance, he/she will initiate the study. Initially will be clinical examination in
           order to report the presence of any of the exclusion criteria already listed. After
           verifying the absence of these criteria, there will be a dental prophylaxis pumice for
           removal of this biofilm and in some cases may be made supragingival scraping. The
           patient will be advised not to make use of any fluoride product during the experiment.
           At first, volunteers are instructed to use a mouthwash without fluoride (wash out) the
           first week, in order to equate the study participants and eliminate any potential
           carryover effects of toothpaste or mouthwash used previously.

           The participant will get a packing of mouthwash and will be instructed to brush their
           teeth for 1 minute with the dentifrice without fluoride and rinse with 10 mL of
           mouthwash for 1 min twice a day (morning and night). On the seventh day, the participant
           will be instructed to brush only the occlusal surfaces of your teeth, to allow biofilm
           accumulation of flat surfaces, and rinse with the mouthwash. When going to bed, you are
           warned not to eat or drink (except water) as well as not brushing your teeth until the
           next day. On the following morning, approximately 12 hours after the last brushing and
           fasting, the first dental biofilm sample and unstimulated saliva is collected. It will
           be used to remove biofilm Hollenback vestibular faces, interproximal, palatal and
           lingual right hemiarch and deposited in a pre-weighed Eppendorf tube in an analytical
           balance. To saliva collection, the participant, at rest, will be instructed to spit for
           a minute in a graduated glass tube. After that, the participant will brush the occlusal
           surfaces for 1 min and rinse with 10 mL of the mouthwash for 1 min. Soon after, will new
           collection of saliva and plaque. Saliva samples will give up in times of 3, 15, 30, 45
           and 60 minutes after brushing, while the biofilm left hemiarch will be collected one
           hour after brushing. After the collection will be offered at breakfast organized by
           researchers participating in the crown of that research center.

        5. Laboratorial phase Samples will be evaluated through physical-chemical analysis of
           fluoride using calibrated fluoride electrode. Samples will be analyzed for fluoride
           concentration using ion-specific electrode after diffusion facilitated with hexamethyl
           disiloxane (HMDS). The calibration curve is made for each analysis. All analyzes will be
           done in triplicate and be submitted for validation.

        6. Data analysis The study data will be analyzed by inferential statistics considering p
           <0.05.
    

Intervention name(s): Mouthwash 100% Nano-F; Mouthwash 50% Nano-F; Mouthwash standard; Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Use 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day.; Use 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day.; Use 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride.; Use 10 ml of mouthwash without fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, triple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of mouthwash with experimental fluoride for one week, with wash-out periods between them
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Fluoride; Dental caries; Mouthwashes