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

NCT ID: NCT02476032

Last Updated: 2017-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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

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Tooth Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Prof applied oxalate

Intervention Type DEVICE

Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.

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.

Group Type ACTIVE_COMPARATOR

Self applied oxalate

Intervention Type DEVICE

Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.

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.

Group Type SHAM_COMPARATOR

Prof applied placebo

Intervention Type DEVICE

Crest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.

Interventions

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Prof applied oxalate

Crest Sensi-Stop strips (Procter \& Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.

Intervention Type DEVICE

Self applied oxalate

Subjects will apply the strips (Procter \& Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.

Intervention Type DEVICE

Prof applied placebo

Crest Sensi-Stop strips (Procter \& Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia A. Lenton, MA, CCRP

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1503M65361

Identifier Type: -

Identifier Source: org_study_id