At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid
In Brief
A clinical study evaluating Dentifrice F-Complex, Dentifrice F-Complex + NaF, and 2 other interventions for Dental Caries. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.