Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity

September 21, 2020 updated by: Procter and Gamble
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine

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

No

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 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 at least one tooth at risk for hypersensitivity.

Exclusion Criteria:

  • any medical condition requiring pre-medication prior to dental procedures
  • any diseases or conditions that might interfere with the subject safely completing the study
  • inability to undergo study procedures
  • a history of kidney stones
  • have self-reported pregnancy or nursing
  • known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: potassium oxalate gel
potassium oxalate gel self applied
Device: Potassium Oxalate Gel
Self applied
Other: oxalate liquid, SnF2 paste
Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Device: Potassium Oxalate Liquid
Professionally Applied
Drug: Stannous fluoride paste
SnF2 Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How Satisfied Were Participants With Treatment?
Time Frame: up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
up to 8 weeks
Ease of Treatment at Home
Time Frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Up to 8 weeks
Did Participants Notice a Difference in the Areas Noted?
Time Frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Up to 8 weeks

Collaborators and Investigators

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

Sponsor

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

November 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014067

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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