Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single centre 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 centre, three day, randomised, 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 use.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test dentifrice | Experimental | Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste. Participants will then first brush each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. |
|
| Control dentifrice | Active Comparator | Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste. Participants will brush the whole mouth thoroughly for at least 1 minute twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride | Other | 0.454% weight by weight (w/w) stannous fluoride containing 1100 parts per million (ppm) fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Day 3 | The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored 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. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. | Baseline and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tactile Threshold 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 gram[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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 | Mississauga | Ontario | L4W 0C2 | Canada |
| 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. |
Not provided
Not provided
A total of 197 participants were screened and enrolled in the study, out of which 192 participants were randomized to the study treatments. Five participants were not randomized: 1 participant was screening failure, and 4 participants withdrew their consent.
Participants were recruited at a single clinical site in Canada.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Test Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. |
| FG001 | Control Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Test Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. |
| BG001 | Control Dentifrice |
| 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 on Day 3 | The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored 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. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. | Analysis for this outcome was performed on Intent-to-treat (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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Day 3 |
Approximately 64 days (from Screening Visit to till 5 days following last administration of study product on Visit 3)
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 Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium monofluorophosphate | Other | 0.76% w/w sodium monofluorophosphate containing 1000 ppm fluoride |
|
| Baseline and Day 3 |
| Change From Baseline in Schiff Sensitivity Score After a Single Use | The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored 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. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. | Baseline to 60 seconds post first treatment |
| Change From Baseline in Tactile Threshold After a Single Use | 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 to 60 seconds post first treatment |
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Test Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily. |
| OG001 | Control Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily. |
|
|
|
| Secondary | Change From Baseline in Tactile Threshold 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 gram[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 performed 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. | Posted | Mean | Standard Deviation | g | Baseline and Day 3 |
|
|
|
| Secondary | Change From Baseline in Schiff Sensitivity Score After a Single Use | The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored 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. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. | Analysis for this outcome was performed 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 60 seconds post first treatment |
|
|
|
| Secondary | Change From Baseline in Tactile Threshold After a Single Use | 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 performed 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. | Posted | Mean | Standard Deviation | g | Baseline to 60 seconds post first treatment |
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 1 |
| 97 |
| EG001 | Control Dentifrice | Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then brushed the whole mouth thoroughly for at least 1 minute twice daily. | 0 | 95 | 0 | 95 | 0 | 95 |
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 |
|
| Change from Baseline |
|
| Change from Baseline |
|