Tooth SensitivitySSDHNCT02476032
An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
A study testing Prof applied oxalate and Self applied oxalate in people with Tooth Sensitivity, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Sensitivity
- What is being tested?
- Prof applied oxalate and Self applied oxalate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Schiff Air Scale = equal to or greater than 1
- Verbal Rating Scale = equal to or greater than 1
- Recession= 1mm or greater
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Tooth Sensitivity
- Being tested
- Prof applied oxalate, Self applied oxalate, Prof applied placebo
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prof applied oxalateDevice
Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
Self applied oxalateDevice
Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
Prof applied placeboDevice
Crest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Prof applied oxalate |
| 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. Receives: Device: Self applied oxalate |
| 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. Receives: Device: Prof applied placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
Secondary outcomes (1)
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
Measured: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth SensitivityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia A. Lenton, MA, CCRP, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476032
- Sponsor's protocol ID
- 1503M65361
- Acronym
- SSDH
- Status last verified
- Sep 2017
- First submitted
- 27 May 2015
- Last updated
- 23 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: At this time, we do not plan to share individual participant data. We are willing to share compiled data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy of Oral-B New Product Sensi-Stop on Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02476032
- Acronym / sponsor ID
- SSDH / 1503M65361
- Conditions
- Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 23 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prof applied oxalate | Experimental | Device: Prof applied oxalateSubjects 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. |
| Self-applied oxalate | Active comparator | Device: Self applied oxalateParticipants 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. |
| Prof applied placebo | Sham comparator | Device: Prof applied placeboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Verbal Rating Scale = equal to or greater than 1
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prof applied oxalateCrest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional. | Device | Prof applied oxalate |
| Self applied oxalateSubjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions. | Device | Self-applied oxalate |
| Prof applied placeboCrest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional. | Device | Prof applied placebo |
Primary outcome
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 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
1 secondary outcome
Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups
Time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. At this time, we do not plan to share individual participant data. We are willing to share compiled data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A. Lenton, MA, CCRP principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prof applied oxalate and Self applied oxalate in people with Tooth Sensitivity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schiff Air Test: Mean Reduction in Sensitivity Between Groups (time frame: 30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.