Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial

Conditions
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Dental Fluorosis, Dental Caries

Intervention / Treatment
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* Other: Low fluoride and conventional dentifrices with different pH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caries-active 550 ppm F, pH 7.0<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|
| Active Comparator: Caries-active 550 ppm F, pH 4.5<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|
| Active Comparator: Caries-active 1100 ppm F, pH 7.0<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|
| Active Comparator: Caries-inactive 550 ppm F, pH 7.0<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|
| Active Comparator: Caries-inactive 550 ppm F, pH 4.5<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|
| Active Comparator: Caries-inactive 1100 ppm F, pH 7.0<br>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<br>* Comparison of different dentifrice fluoride concentrations and pH on caries control<br>* Other names: Dentifrice with 1100 ppm F (NaF) and neutral pH (7.0);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface. | baseline and 12 months | 
| Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface. | 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 %)) | The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression. | 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)) | The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. | baseline and 12 months | 
| Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | The lesions' progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth). | baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluoride, Dentifrices, Nails, Plaque