Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

NCT01049503 | Completed Phase 3 Results DMC

• 1 other identifier: USP0162009
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.

Conditions

Dental Fluorosis; Dental Caries

Keywords

Dentifrices; Fluoride; Nails; Plaque

Outcome Measures

Primary Outcomes (2)

• Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.

  Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).

  6 months

• Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.

  Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).

  6 months

Secondary Outcomes (5)

• Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used

  baseline and 12 months

• Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used

  baseline and 12 months

• Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))

  baseline and 12 months

• Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))

  baseline and 12 months

• Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used

  baseline and 12 months

Study Arms (6)

Caries-active 550 ppm F, pH 7.0

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Caries-active 550 ppm F, pH 4.5

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Caries-active 1100 ppm F, pH 7.0

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-active children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 550 ppm F, pH 7.0

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 550 ppm F, pH 4.5

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Caries-inactive 1100 ppm F, pH 7.0

ACTIVE COMPARATOR

This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area. One drop of the LD (liquid dentifrice) should be used 3 times/day for 12 months.

Other: Low fluoride and conventional dentifrices with different pH

Interventions

Low fluoride and conventional dentifrices with different pH OTHER

Comparison of different dentifrice fluoride concentrations and pH on caries control

Also known as: Dentifrice with 550 ppm F (NaF) and neutral pH (7.0), Dentifrice with 550 ppm F (NaF) and acidic pH (4.5), Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0)

Caries-active 1100 ppm F, pH 7.0; Caries-active 550 ppm F, pH 4.5; Caries-active 550 ppm F, pH 7.0; Caries-inactive 1100 ppm F, pH 7.0; Caries-inactive 550 ppm F, pH 4.5; Caries-inactive 550 ppm F, pH 7.0

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \>= 2 years and \<= 4 years
• Not having participated in any other clinical study within 3 months prior to selection;
• Not having very large carious lesions or dentin sensitivity during the study (if this occurs, the child will be referred for treatment);
• Signature of informed consent by the parents

You may not qualify if:

• Using orthodontic appliances

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Public primary schools in Bauru

Bauru, São Paulo, Brazil

Location

Related Publications (1)

• de Almeida Baldini Cardoso C, Mangueira DF, Olympio KP, Magalhaes AC, Rios D, Honorio HM, Vilhena FV, Sampaio FC, Buzalaf MA. The effect of pH and fluoride concentration of liquid dentifrices on caries progression. Clin Oral Investig. 2014 Apr;18(3):761-7. doi: 10.1007/s00784-013-1031-2. Epub 2013 Jul 20.

  PMID: 23873319 DERIVED

MeSH Terms

Conditions

Fluorosis, Dental; Dental Caries; Plaque, Amyloid

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Marília Buzalaf
• Organization: Bauru Dental School/University of São Paulo

mbuzalaf@fob.usp.br

+55 14 32358346

Study Officials

• Marília AR Buzalaf, PhD

  Bauru Dental School, University of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair professor

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2012
• Last Updated: August 30, 2012
• Results First Posted: August 21, 2012

Record last verified: 2012-08

Locations

BR (1)