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An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity (SSDH)

Primary Purpose

Tooth Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prof applied oxalate
Self applied oxalate
Prof applied placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oral Health Research Clinic at the School of Dentistry at the University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Prof applied oxalate

Self-applied oxalate

Prof applied placebo

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

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 Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2015
Last Updated
September 21, 2017
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02476032
Brief Title
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
Acronym
SSDH
Official Title
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prof applied oxalate
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-applied oxalate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prof applied placebo
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prof applied oxalate
Intervention Description
Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
Intervention Type
Device
Intervention Name(s)
Self applied oxalate
Intervention Description
Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
Intervention Type
Device
Intervention Name(s)
Prof applied placebo
Intervention Description
Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
Primary Outcome Measure Information:
Title
Schiff Air Test: Mean Reduction in Sensitivity Between Groups
Description
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 Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus 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
Secondary Outcome Measure Information:
Title
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A. Lenton, MA, CCRP
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time, we do not plan to share individual participant data. We are willing to share compiled data.

Learn more about this trial

An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity

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