Clinical trial NCT01049503: Effect of pH and Fluoride Concentration of Dentifrices on Caries Control
Official title: Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Fluorosis
Dental Caries
Keywords: Dentifrices
Fluoride
Nails
Plaque
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-01-14
Enrollment: 315
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Dentifrices have been recognized as one of the contributors in the increased prevalence of dental fluorosis, due to the fact that children in early childhood usually eat lots of them during brushing. As an alternative to the reduction of fluorosis have been suggested to reduce the concentration of fluoride toothpaste, however, its efficacy is not well established, increasing when the pH of the toothpaste is acidic, with a greater diffusion of F in the enamel. Therefore, 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. A randomized double-blind study will be conducted with approximately 360 children aged 2 to 4 years old at public daycare centers located in a fluoridated area. Children will be examined by two examiners and classified according to caries activity. For 12 months, children will use 3 times a day, one of the toothpaste to be tested, with different concentrations of fluoride and pH. At the end of this period, children will be examined by the same examiners to check the progression of lesions. Clinical examinations should be performed by 2 calibrated examiners (kappa 0.8) at baseline and after 12 months. The diagnostic criteria of caries activity (active, inactive) and integrity of the surface of the lesion will be used. There will be a quantitative assessment of carious lesions fluorescence with a portable QLF equipment. In half of the sample, nails and plaque will be collected 6 months after initiation of the dentifrices use. Samples of plaque will be analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). The presence of nails F will be analyzed as described above. For statistical analysis will be used ANOVA and test for individual comparisons.

Eligibility criteria: Inclusion Criteria:

* \>= 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

Exclusion Criteria:

* Using orthodontic appliances

Primary outcomes:
measure: Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.
timeFrame: 6 months
measure: Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.
timeFrame: 6 months
Secondary outcomes:
measure: Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
timeFrame: baseline and 12 months
measure: Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
timeFrame: baseline and 12 months
measure: 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 %))
timeFrame: baseline and 12 months
measure: 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))
timeFrame: baseline and 12 months
measure: Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Public primary schools in Bauru
state: São Paulo
Study officials:
affiliation: Bauru Dental School, University of São Paulo
name: Marília AR Buzalaf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.