Dental Caries, Dental Fluorosis
Conditions
Keywords
Dentifrices, Fluoride, Nails, Plaque
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.
Interventions
OTHERLow fluoride and conventional dentifrices with different pH
Comparison of different dentifrice fluoride concentrations and pH on caries control
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. | 6 months | Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). |
| Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. | 6 months | Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | baseline and 12 months | 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. |
| Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | baseline and 12 months | 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). |
| 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 | 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%. |
| Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | baseline and 12 months | 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. |
Countries
Brazil
Participant flow
Recruitment details
This randomized, double-blind clinical trial was approved by the Institutional Review Board of Bauru Dental School (protocol 016/2009). It involved 2 to 4-year-old children that attended five public primary schools, each localized in a different geographical region of Bauru, São Paulo, Brazil (0.6-0.8 ppm F in the drinking water).
Pre-assignment details
From 876 children of the 5 selected schools, 487 did not fill the informed consent. From those who filled the informed consen, 74 missed the clinical examination day or filled the exclusion criteria (had participated in other researches in the last 3 months or children using orthodontic appliances). The total number of children enrolled was 315.
Participants by arm
| Arm | Count |
|---|---|
| Caries-active 550 Ppm F, pH 7.0 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area | 52 |
| Caries-active 550 Ppm F, pH 4.5 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area | 48 |
| Caries-active 1100 Ppm F, pH 7.0 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area | 56 |
| Caries-inactive 550ppm F, pH 7.0 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area | 55 |
| Caries-inactive 550 Ppm F, pH 4.5 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area | 56 |
| Caries-inactive 1100 Ppm F, pH 7.0 This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area | 48 |
| Total | 315 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 12 | 24 | 26 | 27 | 8 |
Baseline characteristics
| Characteristic | Caries-active 550 Ppm F, pH 7.0 | Caries-active 550 Ppm F, pH 4.5 | Caries-active 1100 Ppm F, pH 7.0 | Caries-inactive 550ppm F, pH 7.0 | Caries-inactive 550 Ppm F, pH 4.5 | Caries-inactive 1100 Ppm F, pH 7.0 | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized >= 2 years and <= 4 years | 52 Participants | 48 Participants | 56 Participants | 55 Participants | 56 Participants | 48 Participants | 315 Participants |
| Sex: Female, Male Female | 29 Participants | 25 Participants | 32 Participants | 30 Participants | 27 Participants | 24 Participants | 167 Participants |
| Sex: Female, Male Male | 23 Participants | 23 Participants | 24 Participants | 25 Participants | 29 Participants | 24 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 48 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 48 |
| serious Total, serious adverse events | 0 / 52 | 0 / 48 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 48 |
Outcome results
Primary
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).
Time frame: 6 months
Population: The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. | 1.73 µgF/g | Standard Deviation 0.68 |
| 550 Ppm F, pH 4.5 | Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. | 1.80 µgF/g | Standard Deviation 0.92 |
| 1100 ppmF , pH 7.0 | Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use. | 2.56 µgF/g | Standard Deviation 1.31 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test.p-value: <0.05ANOVA
Primary
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).
Time frame: 6 months
Population: The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. | 0.80 mmol/kg | Standard Deviation 0.08 |
| 550 Ppm F, pH 4.5 | Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. | 1.32 mmol/kg | Standard Deviation 0.23 |
| 1100 ppmF , pH 7.0 | Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use. | 1.74 mmol/kg | Standard Deviation 0.24 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test.p-value: <0.05ANOVA
Secondary
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.
Time frame: baseline and 12 months
Population: The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 2.12 progressed lesions/child | Standard Deviation 3.85 |
| 550 Ppm F, pH 4.5 | Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 0.97 progressed lesions/child | Standard Deviation 1.96 |
| 1100 ppmF , pH 7.0 | Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 1.75 progressed lesions/child | Standard Deviation 2.78 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.p-value: <0.05Kruskal-Wallis
Secondary
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.
Time frame: baseline and 12 months
Population: The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | 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 %)) | 2.66 lesions/child | Standard Deviation 2.52 |
| 550 Ppm F, pH 4.5 | 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 %)) | -3.46 lesions/child | Standard Deviation 5.65 |
| 1100 ppmF , pH 7.0 | 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 %)) | -2.72 lesions/child | Standard Deviation 3.97 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.p-value: <0.05Kruskal-Wallis
Secondary
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%.
Time frame: baseline and 12 months
Population: The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | 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)) | -1.03 lesions/child | Standard Deviation 1.22 |
| 550 Ppm F, pH 4.5 | 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)) | 0.13 lesions/child | Standard Deviation 0.8 |
| 1100 ppmF , pH 7.0 | 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)) | -0.06 lesions/child | Standard Deviation 0.8 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.p-value: <0.05ANOVA
Secondary
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).
Time frame: baseline and 12 months
Population: The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | 0.14 progressed lesions/child | Standard Deviation 0.74 |
| 550 Ppm F, pH 4.5 | Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | 0.03 progressed lesions/child | Standard Deviation 0.18 |
| 1100 ppmF , pH 7.0 | Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used | 0.10 progressed lesions/child | Standard Deviation 0.5 |
Comparison: GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.p-value: <0.05Kruskal-Wallis
Secondary
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.
Time frame: baseline and 12 months
Population: The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 550 Ppm F, pH 7.0 | Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 1.34 regressed lesions/child | Standard Deviation 1.24 |
| 550 Ppm F, pH 4.5 | Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 1.44 regressed lesions/child | Standard Deviation 1.83 |
| 1100 ppmF , pH 7.0 | Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used | 1.84 regressed lesions/child | Standard Deviation 1.57 |
Comparison: The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.p-value: <0.05Kruskal-Wallis