Trial Outcomes & Findings for In Situ Caries Efficacy of Fluoride Toothpastes (NCT NCT00708097)

Last Updated: 2015-01-01

Results Overview

SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2015-01-01

Participant Flow

Two days before the start of each treatment period, participants received a professional dental cleaning of their natural teeth, then brushed at home with the fluoride-free toothpaste.

Participant milestones

Participant milestones
Measure	Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F) Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (1400ppmF) Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Period 1 STARTED	11	12	12	11	11
Period 1 COMPLETED	11	11	12	9	10
Period 1 NOT COMPLETED	0	1	0	2	1
Period 2 STARTED	10	12	10	11	10
Period 2 COMPLETED	10	11	9	10	10
Period 2 NOT COMPLETED	0	1	1	1	0
Period 3 STARTED	9	11	10	10	10
Period 3 COMPLETED	9	11	10	10	10
Period 3 NOT COMPLETED	0	0	0	0	0
Period 4 STARTED	12	9	10	11	8
Period 4 COMPLETED	12	9	10	11	8
Period 4 NOT COMPLETED	0	0	0	0	0
Period 5 STARTED	8	9	11	10	12
Period 5 COMPLETED	8	9	11	10	12
Period 5 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	NaF Toothpaste (1400ppmF) Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Period 1 Protocol Violation	1	0	2	0
Period 1 Other Reason	0	0	0	1
Period 2 Protocol Violation	1	1	1	0

Baseline Characteristics

In Situ Caries Efficacy of Fluoride Toothpastes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=57 Participants All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
Age, Continuous	65.5 years STANDARD_DEVIATION 10.32 • n=99 Participants
Sex: Female, Male Female	34 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Region of Enrollment United States	57 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=50 Participants Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (1400ppmF) n=52 Participants Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaMFP/NaF Toothpaste (1450ppmF) Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)	28.31 Percentage SMHR Standard Error 5.54	26.32 Percentage SMHR Standard Error 5.51	—	—	—

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=50 Participants Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (1400ppmF) n=52 Participants Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaMFP/NaF Toothpaste (1450ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) n=51 Participants Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)	28.31 Percentage SMHR Standard Error 5.54	26.32 Percentage SMHR Standard Error 5.51	26.13 Percentage SMHR Standard Error 5.49	25.52 Percentage SMHR Standard Error 5.48	53.38 Percentage SMHR Standard Error 5.52

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=50 Participants Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (1400ppmF) n=52 Participants Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaMFP/NaF Toothpaste (1450ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) n=51 Participants Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)	34.62 Percentage SMHR Standard Error 2.82	36.06 Percentage SMHR Standard Error 2.79	31.12 Percentage SMHR Standard Error 2.77	27.15 Percentage SMHR Standard Error 2.77	11.10 Percentage SMHR Standard Error 2.80

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.

Outcome measures

Outcome measures
Measure	NaF Toothpaste (1450ppmF) n=50 Participants Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (1400ppmF) n=52 Participants Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaMFP/NaF Toothpaste (1450ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF - 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	NaF Toothpaste (675ppmF) n=53 Participants Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.	Placebo Toothpaste (0ppmF) n=51 Participants Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
Enamel Fluoride Uptake (Sound Enamel Specimens)	648.06 micrograms (μg)*F/centimeters(cm)^2] Standard Error 47.10	650.07 micrograms (μg)*F/centimeters(cm)^2] Standard Error 46.30	541.16 micrograms (μg)*F/centimeters(cm)^2] Standard Error 45.91	487.14 micrograms (μg)*F/centimeters(cm)^2] Standard Error 45.86	425.59 micrograms (μg)*F/centimeters(cm)^2] Standard Error 46.67

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.