Trial Outcomes & Findings for Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions (NCT NCT01641237)

Last Updated: 2014-07-24

Results Overview

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

Baseline to 4 hours

Results posted on

2014-07-24

Participant Flow

Participants were recruited at the clinical site.

A total of 72 participants were screened, and 62 were randomized into the study. 9 participants did not meet the study criteria and 1 withdrew consent. A washout non-fluoridated toothpaste was used for 2 days prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.

Participant milestones

Participant milestones
Measure	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Period I STARTED	16	16	15	15
Period I COMPLETED	16	16	15	15
Period I NOT COMPLETED	0	0	0	0
Period II STARTED	15	16	16	15
Period II COMPLETED	14	16	16	15
Period II NOT COMPLETED	1	0	0	0
Period III STARTED	16	14	15	16
Period III COMPLETED	15	14	15	16
Period III NOT COMPLETED	1	0	0	0
Period IV STARTED	15	15	15	15
Period IV COMPLETED	15	15	15	15
Period IV NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0ppmF) Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Period II Withdrawal by Subject	1	0	0	0
Period III Lost to Follow-up	1	0	0	0

Baseline Characteristics

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=62 Participants All randomized participants who received at least one dose of the study treatments.
Age, Continuous	36.7 Years STANDARD_DEVIATION 12.2 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 4 hours

Population: Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.

Outcome measures

Outcome measures
Measure	NaF Dentifrice (1426 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0 ppmF) n=60 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship	30.89 %SMHR Standard Error 1.38	28.71 %SMHR Standard Error 1.38	25.28 %SMHR Standard Error 1.38	21.03 %SMHR Standard Error 1.39

SECONDARY outcome

Timeframe: Baseline to 4 hours

Population: PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.

Outcome measures

Outcome measures
Measure	NaF Dentifrice (1426 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0 ppmF) n=60 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
%SMHR	30.9 %SMHR Standard Error 1.38	28.7 %SMHR Standard Error 1.38	25.3 %SMHR Standard Error 1.38	21.0 %SMHR Standard Error 1.39

SECONDARY outcome

Timeframe: Baseline to 4 hours

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100.

Outcome measures

Outcome measures
Measure	NaF Dentifrice (1426 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0 ppmF) n=60 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Percentage Relative Erosion Resistance	-38.83 % Relative Erosion Resistance Standard Error 2.75	-39.75 % Relative Erosion Resistance Standard Error 2.75	-50.40 % Relative Erosion Resistance Standard Error 2.75	-71.21 % Relative Erosion Resistance Standard Error 2.77

SECONDARY outcome

Timeframe: Baseline to 4 hours

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.

Outcome measures

Outcome measures
Measure	NaF Dentifrice (1426 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (1150 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	NaF Dentifrice (250 ppmF) n=61 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.	Placebo Dentifrice (0 ppmF) n=60 Participants Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
Enamel Fluoride Uptake (Corrected Data)	3.13 micrograms*F/centimeters^2 Standard Error 0.09	3.07 micrograms*F/centimeters^2 Standard Error 0.09	2.09 micrograms*F/centimeters^2 Standard Error 0.09	1.47 micrograms*F/centimeters^2 Standard Error 0.09

Adverse Events

NaF Dentifrice (1426 ppmF)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

NaF Dentifrice (1150 ppmF)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

NaF Dentifrice (250 ppmF)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Dentifrice (0 ppmF)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NaF Dentifrice (1426 ppmF) n=62 participants at risk Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.	NaF Dentifrice (1150 ppmF) n=61 participants at risk Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.	NaF Dentifrice (250 ppmF) n=62 participants at risk Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.	Placebo Dentifrice (0 ppmF) n=60 participants at risk Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
Gastrointestinal disorders Mouth Ulceration	1.6% 1/62 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	3.3% 2/60 • Number of events 2 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Infections and infestations Nasopharyngitis	1.6% 1/62 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Infections and infestations Tooth Abscess	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Nervous system disorders Sinus Headache	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.7% 1/60 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Gastrointestinal disorders Cheilitis	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Injury, poisoning and procedural complications Mouth Injury	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Gastrointestinal disorders Tongue Hematoma	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Gastrointestinal disorders Abdominal Pain, Upper	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/62 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/61 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.7% 1/60 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
Nervous system disorders Headache	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	1.6% 1/61 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/62 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.

Additional Information

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