NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

August 8, 2013 updated by: Dentsply International

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.

The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Salus Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Availability to complete in the 28 day duration of the study.
  • Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
  • qualifying response to tactile stimuli as defined by a score of </= 20 grams.
  • Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
  • Good general health with no known allergies to products being tested.
  • Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
  • Able to follow study procedures and instructions.
  • Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.

Exclusion Criteria:

  • Individuals who exhibit gross oral pathology
  • Females who may be pregnant or lactating or intending to become pregnant
  • Individuals who require anesthetic during scaling
  • Dental pathology which may cause pain similar to tooth sensitivity
  • Individuals with large amounts of calculus
  • Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
  • Any condition requiring antibiotic prophylaxis for dental treatment
  • Excessive gingival inflammation
  • Individuals who had their teeth cleaned within 30 days of the screening appointment
  • Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
  • Oral pathology, chronic disease, or history of allergy to test products
  • Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
  • Sensitive teeth with mobility greater than one.
  • Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
  • Regular use of sedatives, anti-inflammatory drugs, or analgesic
  • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
  • Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
  • Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
  • Allergies to oral care products, personal care consumer products, or their ingredients.
  • Any subject who, in the judgment of the investigator, should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: NUPRO(r) Classic Prophy Paste
Device: NUPRO Classic Prophy Paste
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Experimental: NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.
Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Experimental: NUPRO Sensodyne Prophy Paste w/ Novamin
Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immediate Sensitivity Relief. Tactile Sensitivity.
Time Frame: Immediately after treatment.
Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Immediately after treatment.
Adverse Events.
Time Frame: Immediately after treatment to 28 days (+/- 2 days) post treatment.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Immediately after treatment to 28 days (+/- 2 days) post treatment.
Immediate Sensitivity Relief. Air Blast Sensitivity.
Time Frame: Immediately after treatment.
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
Immediately after treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extended Sensitivity Relief. Tactile Sensitivity.
Time Frame: 28 days (+/- 2 days) post treatment.
Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with "yes" response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.
28 days (+/- 2 days) post treatment.
Extended Sensitivity Relief. Air Blast Sensitivity.
Time Frame: 28 days (+/- 2 days) post treatment.
Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.
28 days (+/- 2 days) post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dentsply International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffery L. Milleman, DDS, MPA, Salus Research
  • Principal Investigator: Kimberly R. Milleman, ASDH, MS, Salus Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-001

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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