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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test dentifrice | Other | 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse |
|
| Reference dentifrice | Other | 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse |
|
| Comparator dentifrice | Other | 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Dentifrice | Other | Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 60 minutes |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ellesmere Port | Cheshire | CH65 4BW | United Kingdom |
A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.
Participants were recruited at one Centre United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Test/Comparator/Reference: Dentifrice | Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| FG001 | Sequence 2: Test/Reference/Comparator: Dentifrice | Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| FG002 | Sequence 3: Comparator/Test/Reference: Dentifrice | Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| FG003 | Sequence 4: Comparator/Reference/Test: Dentifrice | Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| FG004 | Sequence 5: Reference/Test/Comparator: Dentifrice | Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| FG005 | Sequence 6: Reference/Comparator/Test: Dentifrice | Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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| Washout Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All the participants randomized in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | parts per million(ppm) | 60 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Dentifrice | 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chapped Lips | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| Reference Dentifrice |
| Other |
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3 |
|
| Comparator Dentifrice | Other | Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3 |
|
| Orange Juice | Other | Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms. |
|
| De-ionised water | Other | 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. |
|
| 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 |
| 60 minutes |
| 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 | up to 60 minutes |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Gender | Count of Participants | Participants |
|
| OG001 | Reference Dentifrice | 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse |
| OG002 | Comparator Dentifrice | 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse |
|
|
|
| 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 | 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. | Posted | Mean | Standard Error | ppm | up to 60 minutes |
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | ppm | 60 minutes |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | ppm | up to 60 minutes |
|
|
|
| 0 |
| 28 |
| 8 |
| 28 |
| EG001 | Reference Dentifrice | 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse | 0 | 29 | 3 | 29 |
| EG002 | Comparator Dentifrice | 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse | 0 | 28 | 5 | 28 |
| Nausea | Gastrointestinal disorders |
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| Device failure | General disorders |
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| Medical device complication | General disorders |
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| Malaise | General disorders |
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| Vaccination site pain | General disorders |
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| Influenza | Infections and infestations |
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| Oral herpes | Infections and infestations |
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| Rhinitis | Infections and infestations |
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| Mouth injury | Injury, poisoning and procedural complications |
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| Thermal burn | Injury, poisoning and procedural complications |
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| Headache | Nervous system disorders |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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| Fluoride: At 5 minute (n=27, 27, 27) |
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| Fluoride: At 10 minute (n=26, 26, 26) |
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| Fluoride: At 15 minute (n=27, 27, 26) |
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| Fluoride: At 30 minute (n=26, 27, 27) |
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| Calcium: At Baseline (n=26, 25, 22) |
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| Calcium: At 1 minute (n=23, 28, 25) |
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| Calcium: At 5 minute (n=16, 17, 22) |
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| Calcium: At 10 minute (n=16, 16, 21) |
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| Calcium: At 15 minute (n=18, 20, 20) |
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| Calcium: At 30 minute (n=17, 18, 20) |
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| Calcium: At 60 minute (n=23, 20, 22) |
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| Fluoride: 60 Minutes Post Brushing |
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| Calcium: In initial expectorate |
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| Calcium: Post-Brushing De-Ionised Water Rinse Ex |
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| Calcium: 60 Minutes Post Brushing |
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