Tooth Erosion
Conditions
Brief summary
The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.
Interventions
OTHERReference Dentifrice
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
OTHERComparator Dentifrice
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
OTHERTest Dentifrice
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
OTHEROrange Juice
Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.
OTHERDe-ionised water
Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form * Aged 18-65 years * Understands and is willing, able and likely to comply with all study procedures and restrictions * Good general and mental health with, in the opinion of the investigator or medically qualified designee: 1. No clinically significant and relevant abnormalities of medical history or oral examination 2. Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements * A minimum of 20 permanent natural teeth * A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min.
Exclusion criteria
* Pregnant or breast feeding women * Presence of chronic debilitating disease. * Any condition that causes xerostomia as determined by the Investigator. * Evidence of untreated caries. * Gross periodontal disease. * Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit. * Self reported oral symptoms including lesions, sores or inflammation * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit * Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator * Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase * Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit * Recent history (within the last year) of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | 60 minutes | Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | up to 60 minutes | Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice |
| Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | 60 minutes | Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice |
| Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | up to 60 minutes | Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at one Centre United Kingdom.
Pre-assignment details
A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All the participants randomized in this study. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Washout Period 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 34.8 Years STANDARD_DEVIATION 9.12 |
| Gender Female | 23 Participants |
| Gender Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 28 | 3 / 29 | 5 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 0 / 28 |
Outcome results
Primary
Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Time frame: 60 minutes
Population: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice | Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | 0.23 parts per million(ppm) | Standard Error 0.0469 |
| Reference Dentifrice | Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | 0.23 parts per million(ppm) | Standard Error 0.043 |
| Comparator Dentifrice | Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | 0.15 parts per million(ppm) | Standard Error 0.0485 |
Comparison: Test and Reference dentifrice combined vs. Comparator dentifricep-value: <0.0001ANCOVA
Secondary
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
Time frame: 60 minutes
Population: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Fluoride Ion concentration(n=27, 28, 27) | 0.349 ppm | Standard Error 0.0349 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Calcium Ion concentration (n=26, 22, 25) | 15.015 ppm | Standard Error 4.3355 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Fluoride Ion concentration(n=27, 28, 27) | 0.169 ppm | Standard Error 0.1104 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Calcium Ion concentration (n=26, 22, 25) | 27.263 ppm | Standard Error 4.7113 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Fluoride Ion concentration(n=27, 28, 27) | 0.277 ppm | Standard Error 0.1601 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse | Calcium Ion concentration (n=26, 22, 25) | 14.805 ppm | Standard Error 4.0473 |
Secondary
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
Time frame: up to 60 minutes
Population: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 30 minute (n=17, 18, 20) | 28.650 ppm | Standard Error 1.0725 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 5 minute (n=16, 17, 22) | 27.818 ppm | Standard Error 1.3743 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 30 minute (n=26, 27, 27) | 0.656 ppm | Standard Error 0.1065 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 5 minute (n=27, 27, 27) | 3.881 ppm | Standard Error 0.4115 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 1 minute (n=23, 28, 25) | 28.300 ppm | Standard Error 1.5171 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At Baseline (n=26, 25, 22) | 29.749 ppm | Standard Error 0.9428 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At baseline (n=26, 28, 26) | 0.045 ppm | Standard Error 0.0125 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 1 minute (n=27, 28, 26) | 8.775 ppm | Standard Error 0.8301 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 15 minute (n=18, 20, 20) | 28.319 ppm | Standard Error 1.0783 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 10 minute (n=26, 26, 26) | 1.831 ppm | Standard Error 0.198 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 60 minute (n=23, 20, 22) | 28.198 ppm | Standard Error 1.0073 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 10 minute (n=16, 16, 21) | 27.472 ppm | Standard Error 1.0061 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 15 minute (n=27, 27, 26) | 1.346 ppm | Standard Error 0.1827 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At Baseline (n=26, 25, 22) | 28.357 ppm | Standard Error 1.0162 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At baseline (n=26, 28, 26) | 0.032 ppm | Standard Error 0.0084 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 1 minute (n=27, 28, 26) | 8.794 ppm | Standard Error 1.0562 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 5 minute (n=27, 27, 27) | 4.132 ppm | Standard Error 0.4759 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 10 minute (n=26, 26, 26) | 1.951 ppm | Standard Error 0.2654 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 15 minute (n=27, 27, 26) | 1.188 ppm | Standard Error 0.155 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 30 minute (n=26, 27, 27) | 0.600 ppm | Standard Error 0.081 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 1 minute (n=23, 28, 25) | 27.217 ppm | Standard Error 1.0689 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 5 minute (n=16, 17, 22) | 26.070 ppm | Standard Error 1.4638 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 10 minute (n=16, 16, 21) | 25.672 ppm | Standard Error 1.1944 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 15 minute (n=18, 20, 20) | 27.227 ppm | Standard Error 0.8656 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 30 minute (n=17, 18, 20) | 27.323 ppm | Standard Error 1.0325 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 60 minute (n=23, 20, 22) | 27.094 ppm | Standard Error 1.056 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 5 minute (n=16, 17, 22) | 17.227 ppm | Standard Error 0.917 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 10 minute (n=26, 26, 26) | 1.476 ppm | Standard Error 0.1524 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 30 minute (n=17, 18, 20) | 24.196 ppm | Standard Error 1.3196 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 10 minute (n=16, 16, 21) | 20.133 ppm | Standard Error 1.0395 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 5 minute (n=27, 27, 27) | 3.492 ppm | Standard Error 0.4664 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At baseline (n=26, 28, 26) | 0.031 ppm | Standard Error 0.0072 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 15 minute (n=18, 20, 20) | 23.761 ppm | Standard Error 1.2803 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At Baseline (n=26, 25, 22) | 28.661 ppm | Standard Error 1.0657 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 30 minute (n=26, 27, 27) | 0.479 ppm | Standard Error 0.0723 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 1 minute (n=27, 28, 26) | 7.630 ppm | Standard Error 0.7497 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 1 minute (n=23, 28, 25) | 14.931 ppm | Standard Error 1.0999 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Fluoride: At 15 minute (n=27, 27, 26) | 0.942 ppm | Standard Error 0.1432 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse | Calcium: At 60 minute (n=23, 20, 22) | 27.104 ppm | Standard Error 1.3777 |
Secondary
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Time frame: up to 60 minutes
Population: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: In initial expectorate | 178.522 ppm | Standard Deviation 61.1593 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: Post-Brushing De-Ionised Water Rinse Ex | 8.377 ppm | Standard Deviation 4.2346 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: 60 Minutes Post Brushing | 0.166 ppm | Standard Deviation 0.0609 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: In initial expectorate | 17.096 ppm | Standard Deviation 4.7864 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: Post-Brushing De-Ionised Water Rinse Ex | 4.959 ppm | Standard Deviation 2.2712 |
| Test Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: 60 Minutes Post Brushing | 96.165 ppm | Standard Deviation 9.2357 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: 60 Minutes Post Brushing | 4.600 ppm | Standard Deviation 2.0507 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: In initial expectorate | 168.728 ppm | Standard Deviation 54.378 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: In initial expectorate | 17.467 ppm | Standard Deviation 4.1241 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: Post-Brushing De-Ionised Water Rinse Ex | 4.438 ppm | Standard Deviation 2.2141 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: Post-Brushing De-Ionised Water Rinse Ex | 7.721 ppm | Standard Deviation 4.1721 |
| Reference Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: 60 Minutes Post Brushing | 0.046 ppm | Standard Deviation 0.037 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: Post-Brushing De-Ionised Water Rinse Ex | 7.443 ppm | Standard Deviation 3.4546 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: 60 Minutes Post Brushing | 0.135 ppm | Standard Deviation 0.0563 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: 60 Minutes Post Brushing | 99.189 ppm | Standard Deviation 17.2771 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: In initial expectorate | 2.500 ppm | Standard Deviation 0 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Fluoride: In initial expectorate | 164.708 ppm | Standard Deviation 54.2632 |
| Comparator Dentifrice | Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse | Calcium: Post-Brushing De-Ionised Water Rinse Ex | 2.500 ppm | Standard Deviation 0 |