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The purpose of the study is to evaluate the efficacy of Sensi-StopTM strips (Procter & Gamble™) on the relief of dentinal hypersensitivity. In other words, do Sensi-StopTM strips (Procter & Gamble™) reduce or eliminate cold sensitivity in teeth? In addition, the investigators will evaluate whether there is a difference in the Sensi-StopTM strip (Procter & Gamble™) effectiveness when the product is placed by a dental professional compared to self-placement by the person with sensitive teeth. This product is not experimental.
There are two groups in this research study: 1) The Self Applied group, and 2) the Professionally Applied group.
Once it is determined that interested individuals qualify to participate in the study and have determined that they want to participate, the group that participants are in will be determined. The study has been designed to ensure that 66% of the study participants receives strips that contain the active ingredient and 33% of the subjects receive strips without the active ingredient. This means that there is a 1 out of 3 chance that participants will be assigned to receive the strip(s) without the active desensitizing ingredient. At the end of your 8-week participation, if it turns out that participants received the strips without the active ingredient, they will be offered a sample pack with two strips that contain the active desensitizing ingredient for them to use at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prof applied oxalate | Experimental | Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. |
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| Self-applied oxalate | Active Comparator | Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. |
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| Prof applied placebo | Sham Comparator | Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prof applied oxalate | Device | Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Schiff Air Test: Mean Reduction in Sensitivity Between Groups | An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model. Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity 0 Tooth/Patient did not respond to the air stimulus
| 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model. Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain 0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain |
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Inclusion Criteria:
Patient presents in good general health with no allergies to commercial dental products and are currently not using any desensitizing agents.
If participants are using desensitizing agent the participant must agree to not use any desensitizing agents in the 4 weeks leading up to the baseline data collection appointment and during the following 8 week length of the study.
Patients with a history of having used Sensi-Stop Strips (Procter & Gamble™) in the past will not be eligible to participate because it will not be possible to maintain blindness to the treatment that they receive.
Patients will also have at least the following baseline measurements:
i. Schiff Air Scale = equal to or greater than 1
ii. Verbal Rating Scale = equal to or greater than 1
iii. Recession= 1mm or greater
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A. Lenton, MA, CCRP | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Clinic at the School of Dentistry at the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
At this time, we do not plan to share individual participant data. We are willing to share compiled data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prof Applied Oxalate | Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. |
| FG001 | Self-applied Oxalate | Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. |
| FG002 | Prof Applied Placebo | Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prof Applied Oxalate | Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. |
| 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, Categorical | Count of Participants |
| 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 | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model. Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity 0 Tooth/Patient did not respond to the air stimulus
| Posted | Mean | Standard Error | units on a scale | 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline |
|
Entire length of study
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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 | Prof Applied Oxalate | Subjects will be randomized to either receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied oxalate: Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Lenton Director of Oral Health Research Clinic | University of Minnesota | lento001@umn.edu |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Self applied oxalate | Device | Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. |
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| Prof applied placebo | Device | Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional. |
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| 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline |
| BG001 | Self-applied Oxalate | Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. |
| BG002 | Prof Applied Placebo | Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Schiff Air Scale | Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity 0 Tooth/Patient did not respond to the air stimulus
| Mean | Standard Deviation | units on a scale |
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| Verbal Rating Scale | Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain 0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain | Mean | Standard Deviation | units on a scale |
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Subjects will be randomized to receive the Prof applied oxalate Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Professionally applied Crest Sensi-Stop strips (Procter & Gamble™): Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. |
| OG001 | Self-applied Oxalate | Participants randomized to the Active Comparator Group will have the following intervention: Intervention is the self-applied Crest Sensi-Stop strip (Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied Crest Sensi-Stop strips (Procter & Gamble™): Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. |
| OG002 | Prof Applied Placebo | Subjects will be randomized to receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. |
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| Secondary | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model. Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain 0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain | Posted | Mean | Standard Error | units on a scale | 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline |
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| 0 |
| 20 |
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| 20 |
| EG001 | Self-applied Oxalate | Participants randomized to the Active Comparator Group will have the following intervention: Intervention: self-applied oxalate (Crest Sensi-Stop strip Procter & Gamble™), which contains 3% dipotassium oxalate desensitizing gel. The strip will be placed by the participant, following the manufacturer's directions. The strip will be left in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Self applied oxalate: Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Prof Applied Placebo | Subjects will be randomized to either receive the Prof applied placebo Crest Sensi-Stop strip (Procter & Gamble™). The oxalate strip contains 3% dipotassium oxalate desensitizing gel. The placebo strip is blank (sham). The strips will be placed by a licensed dental professional and will be in place for 10 minutes. Subjects will be instructed to not rinse their mouth, drink, eat or brush their teeth for 30 minutes after completion of the treatment. Prof applied placebo: Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional. | 0 | 20 | 0 | 20 | 0 | 20 |
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| 8 Weeks Post |
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