Back to resultsA Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium oxalate
Sodium fluoride paste
Stannous fluoride paste
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity focused on measuring Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form
- Complete a confidentiality disclosure agreement
- Be in good general health as determined by the Investigator/designee
- Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.
Exclusion Criteria:
- Self-reported pregnancy or nursing
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- Active treatment of periodontitis
- Fixed facial orthodontic appliances
- A history of kidney stones
- Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
- Any diseases or conditions that might interfere with the safe completion of the study
- An inability to undergo any study procedures.
Sites / Locations
- Chad J Anderson DMD Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
oxalate liquid & gel plus SnF2 paste
oxalate liquid & gel plus NaF paste
Arm Description
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
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/subjects responds to stimulus and requests discontinuation or moves from 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
1. Study Identification
Unique Protocol Identification Number
NCT02221349
Brief Title
A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Official Title
A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 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 normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxalate liquid & gel plus SnF2 paste
Arm Type
Other
Arm Description
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Arm Title
oxalate liquid & gel plus NaF paste
Arm Type
Other
Arm Description
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Intervention Type
Device
Intervention Name(s)
Potassium oxalate
Intervention Description
Professionally applied (liquid) and self applied (gel)
Intervention Type
Drug
Intervention Name(s)
Sodium fluoride paste
Other Intervention Name(s)
NaF paste
Intervention Description
Toothpaste used by subject
Intervention Type
Drug
Intervention Name(s)
Stannous fluoride paste
Other Intervention Name(s)
SnF2 paste
Intervention Description
Toothpaste used by subject
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/subjects responds to stimulus and requests discontinuation or moves from 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
60 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
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age
Provide written informed consent prior to participation and be given a signed copy of the informed consent form
Complete a confidentiality disclosure agreement
Be in good general health as determined by the Investigator/designee
Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.
Exclusion Criteria:
Self-reported pregnancy or nursing
Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
Active treatment of periodontitis
Fixed facial orthodontic appliances
A history of kidney stones
Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
Any diseases or conditions that might interfere with the safe completion of the study
An inability to undergo any study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad J Anderson, MS, DMD
Organizational Affiliation
Chad J Anderson DMD Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chad J Anderson DMD Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93730
Country
United States
12. IPD Sharing Statement
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A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
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