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

NCT02809014 | Completed DMC

• 1 other identifier: Fluoride dentifrice tara
• Study Type: interventional
• Target: 24
• 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 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.

Conditions

Dental Caries

Keywords

Fluoride; Dental caries; Dentifrice

Outcome Measures

Primary Outcomes (1)

• Bioavailability of intraoral fluoride (biofilm and saliva)

  six months

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Dentifrice without fluoride and tara gum.

Other: Dentifrice F-Complex; Other: Dentifrice F-Complex + NaF; Other: Dentifrice standard; Other: Dentifrice with tara gum

Dentifrice standard

ACTIVE COMPARATOR

Dentifrice 1100 ppm sodium fluoride (NaF) without tara gum. Positive control

Other: Dentifrice standard

Dentifrice with tara gum

PLACEBO COMPARATOR

Dentifrice without fluoride but with hydrocolloid tara gum.

Other: Dentifrice with tara gum

Dentifrice F-Complex + NaF

EXPERIMENTAL

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

Dentifrice F-Complex

EXPERIMENTAL

Dentifrice experimental with fluoride (1100 ppm) all incorporated in tara gum.

Other: Dentifrice F-Complex

Interventions

Dentifrice F-Complex OTHER

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

Dentifrice F-Complex; Placebo

Dentifrice F-Complex + NaF OTHER

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

Dentifrice F-Complex + NaF; Placebo

Dentifrice standard OTHER

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

Dentifrice standard; Placebo

Dentifrice with tara gum OTHER

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.

Dentifrice with tara gum; 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 (9)

• Aguilar-Galvez A, Noratto G, Chambi F, Debaste F, Campos D. Potential of tara (Caesalpinia spinosa) gallotannins and hydrolysates as natural antibacterial compounds. Food Chem. 2014 Aug 1;156:301-4. doi: 10.1016/j.foodchem.2014.01.110. Epub 2014 Feb 6.

  PMID: 24629972 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Alves VF, Moreira VG, Soares AF, de Albuquerque LS, Moura HS, de Oliveira Silva A, Sampaio FC. A randomized triple-blind crossover trial of a hydrocolloid-containing dentifrice as a controlled-release system for fluoride. Clin Oral Investig. 2018 Dec;22(9):3071-3077. doi: 10.1007/s00784-018-2395-0. Epub 2018 Feb 26.

  PMID: 29484546 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Dentifrices; tara gum

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: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: masking by color and QR code
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The intervention was based on the use of dentifrices: experimental dentifrices: placebo (without F and without tara gum), 100-TGF (NaF associated with tara gum, 1100 mg/L F), 50-TGF (50% NaF associated with tara gum + 50% free NaF, 1100 mg/L F), positive control (PC) (free NaF, 1100 mg/L F), and TG (with tara gum and without F) (Savoy SA, São Paulo, Brazil).

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 22, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

BR (1)