Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.
This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product (0.454% stannous fluoride) | Experimental | Participants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. |
|
| Reference Product (0.76% sodium monofluorophosphate) | Active Comparator | Participants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. |
|
| Negative Control (Mineral water) | Other | Participants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride | Device | Dentifrice containing 0.454% stannous fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded | Baseline and Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded | Baseline, Day 1, 4, and 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bristol | BS1 2LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29981778 | Derived | West NX, Seong J, Hellin N, Macdonald EL, Jones SB, Creeth JE. Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: A randomised clinical in situ study. J Dent. 2018 Sep;76:125-131. doi: 10.1016/j.jdent.2018.07.001. Epub 2018 Jul 5. |
Not provided
Not provided
A total of 26 participants were screened, out of which 24 participants were randomized to the study and 2 participants withdrawn their consent.
Participants were recruited at one center at United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test /Negative Control/Reference | Firstly, participants received dentifrice containing 0.454% stannous fluoride (test), secondly mineral water (negative control) and thirdly dentifrice containing 0.76% sodium monofluorophosphate (reference). Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 milliliters (mL) of mineral water for 5 seconds. |
| FG001 | Test/Reference/Negative Control | Firstly, participants received test dentifrice, secondly reference dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| FG002 | Negative Control/Test/Reference | Firstly, participants received negative control, secondly test dentifrice and thirdly reference dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| FG003 | Negative Control/Reference/Test | Firstly, participants received negative control, secondly reference dentifrice and thirdly test dentifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| FG004 | Reference/Test/Negative Control | Firstly, participants received reference dentifrice, secondly test dentifrice and thirdly negative control. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| FG005 | Reference/Negative Control/Test | Firstly, participants received reference dentifrice, secondly negative control and thirdly test dentrifrice. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Period 2 |
| |||||||||||||||||||
| Period 3 |
|
All randomized participants were included for baseline evaluation
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were included for baseline evaluation. |
| 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 | Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application | Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded | Per protocol (PP) Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Day 8 |
|
Baseline to Day 10
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | Participants used dentifrice containing 0.454% stannous fluoride. Appliances were brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensitivity of Teeth | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C012980 | fluorophosphate |
| D008900 | Mineral Waters |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium monofluorophosphate | Other | Dentifrice containing 0.76% sodium monofluorophosphate |
|
| Mineral water | Other | Commercially available mineral water |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Reference Product | Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
| OG002 | Negative Control | Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. |
|
|
|
| Secondary | Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application | Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded | PP Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 1, 4, and 10 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Reference Product | Participants used dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. | 0 | 22 | 0 | 22 | 4 | 22 |
| EG002 | Negative Control | Participants used commercially available mineral water. Appliances brushed ex situ in mineral water twice daily were then returned to the participant's mouth. Each appliance was brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances were returned to the participant's mouth and the participants rinsed with 10 mL of mineral water for 5 seconds. | 0 | 24 | 0 | 24 | 3 | 24 |
| Pyrexia | General disorders | Systematic Assessment |
|
| TOOTH FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| DYSMENORRHOEA | Reproductive system and breast disorders | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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.
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
|
| Day 1: Change from Baseline |
|
| Day 4: Pre-dose (Baseline) |
|
| Day 4: Post-dose (Post Baseline) |
|
| Day 4: Change from Baseline |
|
| Day 10: Pre-dose (Baseline) |
|
| Day 10: Post-dose (Post Baseline) |
|
| Day 10: Change from Baseline |
|