Evaluation in Vivo of Mouthwash With Nanoencapsulated Fluoride

NCT05143086 | Completed Phase 3 DMC

• 1 other identifier: NanoFMouthwash
• Study Type: interventional
• Target: 21
• 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 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.

Conditions

Dental Caries

Keywords

Fluoride; Dental caries; Mouthwashes

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

Mouthwash without fluoride.

Other: Placebo

Mouthwash standard

ACTIVE COMPARATOR

Mouthwash with 225ppm sodium fluoride (NaF). Positive control.

Other: Mouthwash standard

Mouthwash 50% Nano-F

EXPERIMENTAL

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

Other: Mouthwash 50% Nano-F

Mouthwash 100% Nano-F

EXPERIMENTAL

Mouthwash experimental with fluoride 100% Nanoencapsulated.

Other: Mouthwash 100% Nano-F

Interventions

Mouthwash 100% Nano-F OTHER

Use 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day.

Mouthwash 100% Nano-F

Mouthwash 50% Nano-F OTHER

Use 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day.

Mouthwash 50% Nano-F

Mouthwash standard OTHER

Use 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride.

Mouthwash standard

Placebo OTHER

Use 10 ml of mouthwash without fluoride

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

Mouthwashes

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fábio Sampaio

  University Federal of Paraiba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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

Model Details: A randomized, triple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of mouthwash with experimental fluoride for one week, with wash-out periods between them

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 3, 2021
• Study Start: November 1, 2016
• Primary Completion: November 15, 2017
• Study Completion: December 20, 2017
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2022 - January 2024
• Access Criteria: free

Locations

BR (1)