A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

June 13, 2019 updated by: Procter and Gamble
This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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
    • Ohio
      • Mason, Ohio, United States, 45040
        • Oral Health Science Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be at least 18 years of age
  • sign an informed consent form and be given a copy
  • be in good general health as determined by the Investigator/designee
  • agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
  • agree to not participate in any other oral care study for the duration of this study
  • agree to return for scheduled visits and follow all study procedures
  • have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge

Exclusion Criteria:

  • severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
  • active treatment for periodontitis
  • any diseases or conditions that might interfere with the subject safely completing the study
  • inability to undergo study procedures
  • fixed facial orthodontic appliances
  • a history of kidney stones
  • self-reported pregnancy or nursing
  • known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Crest® Sensi-Stop™ Strips
Professionally Applied
Device: Crest® Sensi-Stop™ Strips
Active Comparator: Colgate® Sensitivity Relief Pen
Professionally Applied
Device: Colgate® Sensitivity Relief Pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Visual Analog Scale
Time Frame: 1 Day
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for Air Challenge
Time Frame: 1 Day
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.
1 Day

Collaborators and Investigators

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

Sponsor

Procter and Gamble

Investigators

  • Principal Investigator: Robert W Gerlach, DDS, MPH, Procter and Gamble

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

February 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015012

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.

Clinical Trials on Dentin Sensitivity

Clinical Trials on Crest® Sensi-Stop™ Strips

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe