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To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after 8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.
This will be a single centre, eight week, randomized, examiner-blind, three treatment, parallel group, stratified study. It will be conducted in healthy participants, with at least two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits. DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Participants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
|
| Negative Control | Other | Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
|
| Placebo | Placebo Comparator | Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium oxalate | Device | Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score | The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tactile Threshold | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
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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 | Fort Wayne | Indiana | 46825 | United States |
A total of 123 participates were screened, out of which 89 participants were enrolled and randomized in the study. 34 participants were not randomized as all the 34 participants did not meet study criteria.
Participants were recruited from one center in USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 milliliters (mL) of oral rinse (1.5% KOX, 0 parts per million [ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| FG001 | Negative Control (0.02% w/w Sodium Fluoride) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% weight by weight [w/w] sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| FG002 | Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population comprised of all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity. | The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | Mean | Standard Deviation | Score on Scale | Week 8 |
|
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 | Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LIP ULCERATION | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2017 | Sep 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2017 | Sep 12, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium fluoride |
| Drug |
Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF) |
|
| Placebo | Other | Oral rinse containing 0% KOX and 0 ppm fluoride |
|
| Week 8 |
| BG001 |
| Negative Control (0.02% w/w Sodium Fluoride) |
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| BG002 | Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) |
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| OG001 | Negative Control (0.02% w/w Sodium Fluoride) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
| OG002 | Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. |
|
|
|
| Secondary | Change From Baseline in Tactile Threshold | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | The ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | Mean | Standard Deviation | Grams | Week 8 |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | Negative Control (0.02% w/w Sodium Fluoride) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. | 0 | 23 | 0 | 23 | 2 | 23 |
| MOUTH ULCERATION | Gastrointestinal disorders | Systematic Assessment |
|
| ORAL DISCOMFORT | Gastrointestinal disorders | Systematic Assessment |
|
| ORAL MUCOSAL EXFOLIATION | Gastrointestinal disorders | Systematic Assessment |
|
| TRAUMATIC ULCER | Injury, poisoning and procedural complications | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | 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 |
|
| ANCOVA | From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate. | <.0001 | P-value from Van Elteren test | Diference of Least Square mean | 49.88 | Standard Error of the Mean | 7.079 | 2-Sided | 95 | 35.791 | 63.966 | Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment. | Other |
| Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model | ANCOVA | From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate. | <.0001 | P-value from Van Elteren test. | Diference of Least Square mean | 43.67 | Standard Error of the Mean | 5.862 | 2-Sided | 95 | 32.001 | 55.334 | Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment. | Other |