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| ID | Type | Description | Link |
|---|---|---|---|
| RH02492 | Other Identifier | GSK |
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The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium nitrate and sodium fluoride | Experimental | 3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride |
|
| Standard fluoride dentifrice | Other | Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium nitrate and sodium fluoride | Drug | 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. | Baseline to 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. |
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Inclusion Criteria:
Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
Participants with minimum of 20 natural teeth.
At screening, a minimum of four, non-adjacent teeth.
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 | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30803493 | Derived | Hall C, Sufi F, Milleman JL, Milleman KR. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study. J Am Dent Assoc. 2019 Mar;150(3):204-212. doi: 10.1016/j.adaj.2018.10.023. |
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The participants were recruited at a clinical site in the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | Dentifrice Plus Oral Rinse | 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice |
| FG001 | Dentifrice Alone | Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dentifrice Plus Oral Rinse | 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice |
| BG001 | Dentifrice Alone | Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) |
| 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 | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline to 8 week |
|
Upto 8 weeks
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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 | Dentifrice Plus Oral Rinse | 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensitivity of teeth | Gastrointestinal disorders | Systematic Assessment |
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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 |
|---|---|
| C023844 | potassium nitrate |
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Standard fluoride dentifrice | Drug | Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP |
|
| Baseline to 4 week |
| Mean Change From Baseline in Tactile Threshold at Week 8 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | Baseline to 8 week |
| Mean Change From Baseline in Tactile Threshold at Week 4 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | Baseline to 4 week |
| Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | Baseline to 8 week |
| Mean Change From Baseline in VRS at Week 4 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | Baseline to 4 week |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Dentifrice Plus Oral Rinse |
3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice |
| OG001 | Dentifrice Alone | Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) |
|
|
|
| Secondary | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Scores on scale | Baseline to 4 week |
|
|
|
| Secondary | Mean Change From Baseline in Tactile Threshold at Week 8 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Gram(g) | Baseline to 8 week |
|
|
|
| Secondary | Mean Change From Baseline in Tactile Threshold at Week 4 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Gram (g) | Baseline to 4 week |
|
|
|
| Secondary | Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on scale | Baseline to 8 week |
|
|
|
| Secondary | Mean Change From Baseline in VRS at Week 4 | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. | The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on scale | Baseline to 4 week |
|
|
|
| 0 |
| 95 |
| 11 |
| 95 |
| EG001 | Dentifrice Alone | Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) | 0 | 96 | 7 | 96 |
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Traumatic ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Device failure | General disorders | Systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue 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.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |