| ID | Type | Description | Link |
|---|---|---|---|
| RH01327 | Other Identifier | GSK |
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A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentifrice containing stannous fluoride | Experimental | Toothpaste |
|
| Dentifrice containing Sodium Monofluorophosphate | Active Comparator | Toothpaste |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride | Drug | Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27093773 | Derived | Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32. |
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Total 394 participants were screened, out of which 120 participants were randomized. 274 participants were not randomized because 248 participants did not meet the study criteria, 4 participants were lost to follow up, and 7 participants withdrew the consent and 15 participants for other reasons (not-specified).
Participants were recruited at a single center in Ireland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Dentifrice | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. |
| FG001 | Reference Dentifrice | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Dentifrice | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 on Day 14 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. | Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 14 |
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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 | Experimental Dentifrice | Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensitivity of Teeth | Gastrointestinal 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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| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium Monofluorophosphate | Drug | Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute. |
|
| Baseline, post first brushing (after 5 minutes) and Day 3 |
| Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. | Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 |
| Reference Dentifrice |
Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG000 |
| Experimental Dentifrice |
Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute. |
| OG001 | Reference Dentifrice | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. |
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| Secondary | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. | Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post first brushing (after 5 minutes) and Day 3 |
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| Secondary | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. | Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. | Posted | Mean | Standard Deviation | gram (g) | Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 |
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| 0 |
| 60 |
| 0 |
| 60 |
| 9 |
| 60 |
| EG001 | Reference Dentifrice | Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute. | 0 | 60 | 0 | 60 | 8 | 60 |
| Dry Mouth | Gastrointestinal disorders |
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| Gingival Bleeding | Gastrointestinal disorders |
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| Gingivitis | Gastrointestinal disorders |
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| Mouth Ulceration | Gastrointestinal disorders |
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| Oral Herpes | Infections and infestations |
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| Tooth Injury | Injury, poisoning and procedural complications |
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| Toothache | Gastrointestinal disorders |
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| Axillary Candidiasis | Infections and infestations |
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| Axillary Pain | General disorders |
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| Gastroenteritis Viral | Infections and infestations |
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| Headache | Nervous system disorders |
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| Influenza Like Illness | General disorders |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders |
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| Viral Infection | Infections and infestations |
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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.
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Change after 5 minutes of brushing |
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| On Day 3 |
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| Change from baseline on Day 3 |
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| After 5 minutes of brushing |
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| Change after 5 minutes of brushing |
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| On Day 3 |
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| Change from baseline on Day 3 |
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| On Day 14 |
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| Change from baseline on Day 14 |
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