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This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stannous Fluoride Dentifrice | Experimental | Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water. |
|
| Sodium monofluorophosphate Dentifrice | Other | Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride Dentifrice | Other | Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Day 14 | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Day 7 | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. |
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Inclusion Criteria:
No clinically significant and relevant abnormalities of medical history or oral examination.
Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes[Y]/No[N] response).
Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).
Exclusion Criteria:
Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mississauga | Ontario | L4W 0C2 | Canada |
A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.
Participants were recruited at a single center in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stannous Fluoride Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. |
| FG001 | Sodium Monofluorophosphate Dentifrice | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One participant was randomized to sodium monofluorophosphate dentifrice but received stannous fluoride dentifrice, therefore, treatment arm "stannous fluoride dentifrice" included 72 participants & treatment arm "sodium monofluorophosphate dentifrice" included 69 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stannous Fluoride Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. |
| 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 Schiff Sensitivity Score at Day 14 | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. | Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 14 |
From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" & 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
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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 | Stannous Fluoride Dentifrice | Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Sodium monofluorophosphate Dentifrice | Other | Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) |
|
| Baseline, Day 7 |
| Change From Baseline in Tactile Threshold at Day 7 and Day 14 | A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth. | Baseline, Day 7 and Day 14 |
| BG001 | Sodium Monofluorophosphate Dentifrice | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Stannous Fluoride Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water. |
| OG001 | Sodium Monofluorophosphate Dentifrice | Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. |
|
|
|
| Secondary | Change From Baseline in Schiff Sensitivity Score at Day 7 | Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. | Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 7 |
|
|
|
| Secondary | Change From Baseline in Tactile Threshold at Day 7 and Day 14 | A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth. | Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | gram (g) | Baseline, Day 7 and Day 14 |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 3 |
| 72 |
| EG001 | Sodium Monofluorophosphate Dentifrice | Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water. | 0 | 69 | 0 | 69 | 0 | 69 |
| Influenza | Infections and infestations |
|
| Headache | Nervous system 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.
| Change from Baseline at Day 14 |
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