- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02476032
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity (SSDH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
|
Active Comparator: 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.
|
Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
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Sham Comparator: 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.
|
Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Schiff Air Test: Mean Reduction in Sensitivity Between Groups
Time Frame: 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
|
30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups
Time Frame: 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 |
30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patricia A. Lenton, MA, CCRP, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1503M65361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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