Trial Outcomes & Findings for Effect of pH and Fluoride Concentration of Dentifrices on Caries Control (NCT NCT01049503)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

315 participants

Primary outcome timeframe

6 months

Results posted on

2012-08-30

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	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	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	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	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	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	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
Overall Study STARTED	52	48	56	55	56	48
Overall Study COMPLETED	41	36	32	29	29	40
Overall Study NOT COMPLETED	11	12	24	26	27	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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	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	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	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
Overall Study Lost to Follow-up	11	12	24	26	27	8

Baseline Characteristics

Effect of pH and Fluoride Concentration of Dentifrices on Caries Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caries-active 550 Ppm F, pH 7.0 n=52 Participants 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	Caries-active 550 Ppm F, pH 4.5 n=48 Participants 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	Caries-active 1100 Ppm F, pH 7.0 n=56 Participants 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	Caries-inactive 550ppm F, pH 7.0 n=55 Participants 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	Caries-inactive 550 Ppm F, pH 4.5 n=56 Participants 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	Caries-inactive 1100 Ppm F, pH 7.0 n=48 Participants 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	Total n=315 Participants Total of all reporting groups
Age, Customized >= 2 years and <= 4 years	52 Participants n=5 Participants	48 Participants n=7 Participants	56 Participants n=5 Participants	55 Participants n=4 Participants	56 Participants n=21 Participants	48 Participants n=8 Participants	315 Participants n=8 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	30 Participants n=4 Participants	27 Participants n=21 Participants	24 Participants n=8 Participants	167 Participants n=8 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	25 Participants n=4 Participants	29 Participants n=21 Participants	24 Participants n=8 Participants	148 Participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=16 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=15 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=16 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	1.32 mmol/kg Standard Deviation 0.23	1.74 mmol/kg Standard Deviation 0.24

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=58 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=53 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=50 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	1.80 µgF/g Standard Deviation 0.92	2.56 µgF/g Standard Deviation 1.31

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=41 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=36 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=32 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	0.97 progressed lesions/child Standard Deviation 1.96	1.75 progressed lesions/child Standard Deviation 2.78

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=41 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=36 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=32 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	1.44 regressed lesions/child Standard Deviation 1.83	1.84 regressed lesions/child Standard Deviation 1.57

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=11 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=18 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=16 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	-3.46 lesions/child Standard Deviation 5.65	-2.72 lesions/child Standard Deviation 3.97

SECONDARY outcome

Timeframe: 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.

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%.

Outcome measures

Outcome measures
Measure	550 Ppm F, pH 7.0 n=11 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	550 Ppm F, pH 4.5 n=18 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.	1100 ppmF , pH 7.0 n=16 Participants This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
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	0.13 lesions/child Standard Deviation 0.80	-0.06 lesions/child Standard Deviation 0.80

SECONDARY outcome

Timeframe: 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.

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).