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

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ClinicalTrials.gov Identifier: NCT02809014
Recruitment Status : Unknown
Verified December 2016 by Fabio Correia Sampaio, Federal University of Paraíba.
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Fabio Correia Sampaio, Federal University of Paraíba

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Dentifrice F-Complex Other: Dentifrice F-Complex + NaF Other: Dentifrice standard Other: Dentifrice with tara gum Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid
Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Placebo Comparator: Placebo
Dentifrice without fluoride and tara gum.
Other: Dentifrice F-Complex
Use of few of dentifrice on brushing for one week, twice day.

Other: Dentifrice F-Complex + NaF
Use of few of dentifrice on brushing for one week, twice day.

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

Other: Dentifrice with tara gum
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.

Active Comparator: Dentifrice standard
Dentifrice 1100 ppm sodium fluoride (NaF) without tara gum. Positive control
Other: Dentifrice standard
Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluoride

Placebo Comparator: Dentifrice with tara gum
Dentifrice without fluoride but with hydrocolloid tara gum.
Other: Dentifrice with tara gum
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.

Experimental: Dentifrice F-Complex + NaF
Dentifrice experimental with fluoride (1100 ppm) being half of fluoride incorporated in tara gum and other half freeform of NaF
Other: Dentifrice F-Complex + NaF
Use of few of dentifrice on brushing for one week, twice day.

Experimental: Dentifrice F-Complex
Dentifrice experimental with fluoride (1100 ppm) all incorporated in tara gum.
Other: Dentifrice F-Complex
Use of few of dentifrice on brushing for one week, twice day.




Primary Outcome Measures :
  1. Bioavailability of intraoral fluoride (biofilm and saliva) [ Time Frame: six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • resident in João Pessoa
  • Decayed, Missing, Filled Index<6
  • Healthy

Exclusion Criteria:

  • orthodontic treatment
  • gingivitis
  • Periodontal disease
  • Smokers
  • Present active tooth decay
  • Tooth sensitivity
  • Those undergoing treatment with fluoride products and / or use of antimicrobials in the past four weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809014


Locations
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Brazil
Federal University of Paraíba
João Pessoa, Paraíba, Brazil
Sponsors and Collaborators
Fabio Correia Sampaio
Investigators
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Study Director: Fábio Sampaio, Doctor University Federal of Paraiba

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabio Correia Sampaio, Professor, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02809014    
Other Study ID Numbers: Fluoride dentifrice tara
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fabio Correia Sampaio, Federal University of Paraíba:
Fluoride
Dental caries
Dentifrice
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs