Tooth Sensitivity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEProf applied oxalate
Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
DEVICESelf applied oxalate
Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
DEVICEProf applied placebo
Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
* Any dental pathology resulting in pain that could confound the study findings would render the patient ineligible: e.g. advanced dental decay, pulpitis, fractured teeth, fractured restorations, chipped teeth, cracked teeth, severe gingival inflammation, post-restorative sensitivity, marginal leakage, severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession. * Also, if potential study subjects are not willing to agree to avoid the use of desensitizing and/or whitening products they will not be enrolled. * Adults lacking in the ability to give consent will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline | 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 1. Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus 2. Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus 3. Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Prof Applied Oxalate | Self-applied Oxalate | Prof Applied Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 19 Participants | 58 Participants |
| Age, Continuous | 43.8 years STANDARD_DEVIATION 16.1 | 47.3 years STANDARD_DEVIATION 12 | 40.3 years STANDARD_DEVIATION 15.4 | 43.8 years STANDARD_DEVIATION 14.5 |
| Race/Ethnicity, Customized African American | 2 participants | 3 participants | 4 participants | 9 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 17 participants | 17 participants | 14 participants | 48 participants |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Schiff Air Scale | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 2.3 units on a scale STANDARD_DEVIATION 0.8 | 2.0 units on a scale STANDARD_DEVIATION 0.9 | 1.9 units on a scale STANDARD_DEVIATION 0.83 |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 15 Participants | 44 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 5 Participants | 16 Participants |
| Verbal Rating Scale | 4.3 units on a scale STANDARD_DEVIATION 1.9 | 6.5 units on a scale STANDARD_DEVIATION 1.8 | 5.8 units on a scale STANDARD_DEVIATION 2.1 | 5.5 units on a scale STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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 1. Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus 2. Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus 3. Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus
Time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prof Applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -0.66 units on a scale | Standard Error 0.23 |
| Prof Applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -1.11 units on a scale | Standard Error 0.26 |
| Prof Applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -1.24 units on a scale | Standard Error 0.26 |
| Self-applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -0.86 units on a scale | Standard Error 0.26 |
| Self-applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -1.12 units on a scale | Standard Error 0.26 |
| Self-applied Oxalate | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -1.12 units on a scale | Standard Error 0.23 |
| Prof Applied Placebo | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -0.22 units on a scale | Standard Error 0.24 |
| Prof Applied Placebo | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -0.78 units on a scale | Standard Error 0.25 |
| Prof Applied Placebo | Schiff Air Test: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -0.52 units on a scale | Standard Error 0.22 |
Comparison: Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.p-value: 0.05t-test, 2 sided
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
Time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prof Applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -1.27 units on a scale | Standard Error 0.42 |
| Prof Applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -2.26 units on a scale | Standard Error 0.52 |
| Prof Applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -2.22 units on a scale | Standard Error 0.51 |
| Self-applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -1.85 units on a scale | Standard Error 0.41 |
| Self-applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -1.34 units on a scale | Standard Error 0.52 |
| Self-applied Oxalate | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -1.66 units on a scale | Standard Error 0.52 |
| Prof Applied Placebo | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 30 Minutes Post | -0.83 units on a scale | Standard Error 0.39 |
| Prof Applied Placebo | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 8 Weeks Post | -1.33 units on a scale | Standard Error 0.5 |
| Prof Applied Placebo | Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups | 4 Weeks Post | -0.20 units on a scale | Standard Error 0.48 |
Comparison: Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.p-value: 0.05t-test, 2 sided