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This single center, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.
This will be a single center, three day, randomized, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: stannous fluoride | Experimental | Participants will be instructed to dose a dry toothbrush containing 0.454% w/w of stannous fluoride (1000 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. |
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| Standard: sodium monofluorophosphate | Active Comparator | Participants will be instructed to dose a dry toothbrush containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stannous fluoride | Drug | 0.454% w/w stannous fluoride containing 1100ppm of fluoride |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on 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 indicates improvement in sensitivity. | Baseline, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score After Single Use | 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. |
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Inclusion Criteria:
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 | Las Vegas | Nevada | 89146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31164116 | Derived | Creeth J, Gallob J, Sufi F, Qaqish J, Gomez-Pereira P, Budhawant C, Goyal C. Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief. BMC Oral Health. 2019 Jun 4;19(1):98. doi: 10.1186/s12903-019-0781-x. |
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A total of 266 participants were screened, out of which 242 participants were randomized. 24 participants were not randomized because 14 participants did not met the study criteria, 1 participant was lost to follow up and 9 participants withdrew consent from the study.
Participants were recruited at one center in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Stannous Fluoride(SnF) | Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
| FG001 | Control: Sodium Monofluorophosphate(SMFP) | Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Stannous Fluoride(SnF) | Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
| 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 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 indicates improvement in sensitivity. | Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 3 |
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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: Stannous Fluoride(SnF) | Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Mucosal Exfoliation | 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 | 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride |
|
| Baseline, after single use (after 5 minutes) |
| Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3 | 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, after single use (after 5 minutes) and on Day 3 |
| BG001 | Control: Sodium Monofluorophosphate(SMFP) | Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
| 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 |
|
| Shiff Sensitivity Score at Baseline | Assessed by examiner as participant's response to an evaporative (air) stimulus after stimulation of each individual tooth, 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 & requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, & requests discontinuation of stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. | This baseline measurement was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. | Mean | Standard Deviation | score on a scale |
|
| Tactile Threshold at Baseline | 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. Tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. Tactile threshold for each tooth was determined by asking participant whether sensation caused discomfort. The pressure setting at which participant gave two consecutive 'yes' responses was recorded as tactile threshold. Higher tactile threshold, less sensitive tooth. | This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. | Mean | Standard Deviation | gram (g) |
|
| OG000 | Experimental: Stannous Fluoride(SnF) | Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
| OG001 | Control: Sodium Monofluorophosphate(SMFP) | Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. |
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|
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| Secondary | Change From Baseline in Schiff Sensitivity Score After Single Use | 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 ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is the ITT Population evaluated post treatment single usage for each treatment arms. | Posted | Mean | Standard Deviation | score on a scale | Baseline, after single use (after 5 minutes) |
|
|
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| Secondary | Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3 | 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, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively. | Posted | Mean | Standard Deviation | g | Baseline, after single use (after 5 minutes) and on Day 3 |
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|
| 0 |
| 121 |
| 0 |
| 121 |
| 1 |
| 121 |
| EG001 | Standard: Sodium Monofluorophosphate(SMFP) | Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. | 0 | 121 | 0 | 121 | 2 | 121 |
| Leukoplakia Oral | Gastrointestinal disorders |
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| Lip Ulceration | Gastrointestinal disorders |
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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 from baseline on Day 3 |
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