In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The literature recognizes that fluoride is the most widely used and studied means for dental
      remineralization. The use of fluoride toothpaste in brushing is considered more rational
      method for the prevention of caries. However, the current challenge of toothpaste is the
      substantivity, so new compounds have been introduced into these formulations. This study aims
      to evaluate the in vivo effect of fluoride dentifrice containing a natural product -
      hydrocolloid tara gum - 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
      brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after.
      It will be 4 toothpastes: 1100ppm F- with hydrocolloid; F- 550ppm with hydrocolloid; 1100ppm
      F- without hydrocolloid; Without fluoride with hydrocolloid. Between weeks of use, brushing
      will be extended washout (without fluoride and no hydrocolloid) 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 hydrocolloid 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 toothpastes containing natural hydrocolloid, it will be collected biofilm
           samples 1h and 12 h after brushing; 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 dentifrice (1100 ppm F with hydrocolloid) 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 Dentifrice For this study will be used five toothpastes: 1100ppm F- with
           hydrocolloid; F- 550ppm with hydrocolloid; 1100ppm F- without hydrocolloid; Without
           fluoride with hydrocolloid; Without fluoride and no hydrocolloid. The toothpaste, made
           available by the company from Brazil are packed in the same packaging and have the taste
           of tutti frutti. Except wash out the tubes with toothpaste will be identified by colors
           (yellow, green, red and blue) by an independent researcher. The color 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 toothpaste without fluoride and without
           hydrocolloid. In the end, all study participants will use the 5 experimental dentifrice
           at different times.

        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 toothpaste without fluoride and no
           hydrocolloid (wash out) the first week, in order to equate the study participants and
           eliminate any potential carryover effects of toothpaste used previously.

           The participant will get a tube of toothpaste and will be instructed to brush their
           teeth for 1 minute and rinse with 10 mL of water 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. 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 water. 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): Dentifrice F-Complex; Dentifrice F-Complex + NaF; Dentifrice standard; Dentifrice with tara gum
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Use of few of dentifrice on brushing for one week, twice day.; Use of few of dentifrice on brushing for one week, twice day.; Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluoride; Use of few of dentifrice on brushing for one week, twice day. It's for analysis of negative control of fluoride and action only of tara gum.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The intervention was based on the use of dentifrices: experimental dentifrices: placebo (without F and without tara gum), 100-TGF (NaF associated with tara gum, 1100 mg/L F), 50-TGF (50% NaF associated with tara gum + 50% free NaF, 1100 mg/L F), positive control (PC) (free NaF, 1100 mg/L F), and TG (with tara gum and without F) (Savoy SA, São Paulo, Brazil).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Fluoride; Dental caries; Dentifrice