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Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium oxalate
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provide written informed consent to participate in the study
  • Be at least 18 years of age
  • Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
  • Agree to refrain from participating in any other oral/dental product studies for the duration of the study
  • Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
  • Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
  • Agree to comply with study/product usage instructions; and
  • Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

  • Gross oral neglect or urgent dental treatment needs
  • Severe periodontal disease and/or generalized mobility
  • Active treatment for periodontitis
  • Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
  • Self-reported pregnancy or nursing

Sites / Locations

  • Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

potassium oxalate gel

Potassium oxalate liquid

Arm Description

Professional application

Professional application

Outcomes

Primary Outcome Measures

Change From Baseline Air Challenge
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

Secondary Outcome Measures

Change From Baseline Visual Analog Scale
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.

Full Information

First Posted
July 14, 2014
Last Updated
October 17, 2019
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT02192307
Brief Title
Effectiveness of Two Water-Based Potassium Oxalate Desensitizers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
potassium oxalate gel
Arm Type
Experimental
Arm Description
Professional application
Arm Title
Potassium oxalate liquid
Arm Type
Active Comparator
Arm Description
Professional application
Intervention Type
Device
Intervention Name(s)
Potassium oxalate
Other Intervention Name(s)
Professional application
Primary Outcome Measure Information:
Title
Change From Baseline Air Challenge
Description
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change From Baseline Visual Analog Scale
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provide written informed consent to participate in the study Be at least 18 years of age Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study Agree to refrain from participating in any other oral/dental product studies for the duration of the study Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study Agree to comply with study/product usage instructions; and Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening Exclusion Criteria: Gross oral neglect or urgent dental treatment needs Severe periodontal disease and/or generalized mobility Active treatment for periodontitis Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study Self-reported pregnancy or nursing
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

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