CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Dentifrice F-Complex +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02809014
NCT02809014N/ACompleted

In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid

Fabio Correia Sampaio·interventional·Posted Jun 22, 2016·Updated May 20, 2022

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 22, 2016
Enrollment StartFeb 1, 2016
Primary CompletionDec 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.0 years ago

Interventions

Dentifrice F-Complexother

Use of few of dentifrice on brushing for one week, twice day.

Dentifrice F-Complex + NaFother

Use of few of dentifrice on brushing for one week, twice day.

Dentifrice standardother

Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluoride

Dentifrice with tara gumother

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.