Evaluation in Vivo of Dentifrice With Nanoencapsulated Fluoride

NCT03008759 | Unknown Phase 1 DMC

• 1 other identifier: NanoF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 nanoencapsulated Fluoride (Nano-F) - 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 3 toothpastes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, brushing 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

Conditions

Dental Caries

Keywords

Fluoride; Dental caries; Dentifrice

Outcome Measures

Primary Outcomes (1)

• Bioavailability of intraoral fluoride (biofilm and saliva)

  collection of dental plaque(biofilm) and saliva

  six months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Dentifrice without fluoride

Other: Dentifrice 100% Nano-F; Other: Dentifrice 50% Nano-F; Other: Dentifrice standard

Dentifrice standard

ACTIVE COMPARATOR

Dentifrice 1100 ppm sodium fluoride (NaF). Positive control

Other: Dentifrice standard

Dentifrice 50% Nano-F

EXPERIMENTAL

Dentifrice experimental with Fluoride being half of fluoride Nanoencapsulated and other half freeform of NaF

Other: Dentifrice 50% Nano-F

Dentifrice 100% Nano-F

EXPERIMENTAL

Dentifrice experimental with fluoride 100% Nanoencapsulated

Other: Dentifrice 100% Nano-F

Interventions

Dentifrice 100% Nano-F OTHER

Use of few of dentifrice 100% Nanoencapsulated Fluoride on brushing for one week, twice day.

Dentifrice 100% Nano-F; Placebo

Dentifrice 50% Nano-F OTHER

Use of few of dentifrice 50% Nanoencapsulated Fluoride on brushing for one week, twice day.

Dentifrice 50% Nano-F; Placebo

Dentifrice standard OTHER

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

Dentifrice standard; Placebo

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fabio Correia Sampaio: lead

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, Brazil

Location

Related Publications (7)

• Buzalaf MA, Vilhena FV, Iano FG, Grizzo L, Pessan JP, Sampaio FC, Oliveira RC. The effect of different fluoride concentrations and pH of dentifrices on plaque and nail fluoride levels in young children. Caries Res. 2009;43(2):142-6. doi: 10.1159/000211717. Epub 2009 Apr 8.

  PMID: 19365118 RESULT

• Whitford GM, Wasdin JL, Schafer TE, Adair SM. Plaque fluoride concentrations are dependent on plaque calcium concentrations. Caries Res. 2002 Jul-Aug;36(4):256-65. doi: 10.1159/000063931.

  PMID: 12218274 RESULT

• Pessan JP, Silva SM, Lauris JR, Sampaio FC, Whitford GM, Buzalaf MA. Fluoride uptake by plaque from water and from dentifrice. J Dent Res. 2008 May;87(5):461-5. doi: 10.1177/154405910808700501.

  PMID: 18434577 RESULT

• Pessan JP, Pinto Alves KM, Italiani Fde M, Ramires I, Lauris JR, Whitford GM, Toumba KJ, Robinson C, Buzalaf MA. Distribution of fluoride and calcium in plaque biofilms after the use of conventional and low-fluoride dentifrices. Int J Paediatr Dent. 2014 Jul;24(4):293-302. doi: 10.1111/ipd.12073.

  PMID: 25045768 RESULT

• Pessan JP, Conceicao JM, Grizzo LT, Szekely M, Fazakas Z, Buzalaf MA. Intraoral fluoride levels after use of conventional and high-fluoride dentifrices. Clin Oral Investig. 2015 May;19(4):955-8. doi: 10.1007/s00784-015-1426-3. Epub 2015 Feb 14.

  PMID: 25677244 RESULT

• Duckworth RM, Jones S. On the relationship between the rate of salivary flow and salivary fluoride clearance. Caries Res. 2015;49(2):141-6. doi: 10.1159/000365949. Epub 2015 Jan 27.

  PMID: 25634162 RESULT

• Duckworth RM, Morgan SN, Gilbert RJ. Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments. J Dent Res. 1992 Apr;71 Spec No:836-40. doi: 10.1177/002203459207100S09.

  PMID: 1592970 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Fábio Sampaio, Doctor

  University Federal of Paraiba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: January 2, 2017
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: January 2, 2017

Record last verified: 2016-11

Locations

BR (1)