Back to resultsEvaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium Oxalate
Water
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;
- agree not to participate in any other oral/dental product studies during the course of this study;
- agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
- agree to refrain from the use of any non-study oral hygiene products;
- agree to return for all scheduled visits and follow study procedures; and.
- have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile 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; or
- an inability to undergo any study procedures.
Sites / Locations
- Silverstone Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Potassium Oxalate Gel
Water
Arm Description
Self Applied
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/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 in Tactile Threshold
Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02189382
Brief Title
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on 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
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Potassium Oxalate Gel
Arm Type
Experimental
Arm Description
Self Applied
Arm Title
Water
Arm Type
Other
Arm Description
Self Applied
Intervention Type
Device
Intervention Name(s)
Potassium Oxalate
Intervention Type
Other
Intervention Name(s)
Water
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 in Tactile Threshold
Description
Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
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:
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;
agree not to participate in any other oral/dental product studies during the course of this study;
agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
agree to refrain from the use of any non-study oral hygiene products;
agree to return for all scheduled visits and follow study procedures; and.
have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile 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; or
an inability to undergo any study procedures.
Facility Information:
Facility Name
Silverstone Research Group
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
12. IPD Sharing Statement
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Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
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