At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation in Vivo of Experimental Mouthwash With Nanoencapsulated Fluoride
In Brief
A Phase 3 clinical trial evaluating Mouthwash 100% Nano-F, Mouthwash 50% Nano-F, and 2 other interventions for Dental Caries. Completed, enrolled 21 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 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.
Study Details
Timeline
Interventions
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