Back to resultsEffects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxalate Salt Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
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, 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 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:
- 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 orthodontic appliances
Sites / Locations
- Silverstone Research Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oxalate Salt Solution
No Treatment
Arm Description
Professionally applied
No Treatment
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. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Secondary Outcome Measures
Change From Baseline for Yeaple Probe
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
NCT02481557
Brief Title
Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
5. Study Description
Brief Summary
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxalate Salt Solution
Arm Type
Experimental
Arm Description
Professionally applied
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
No Treatment
Intervention Type
Device
Intervention Name(s)
Oxalate Salt Solution
Intervention Description
Applied by dentist
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. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Time Frame
10 Minutes
Secondary Outcome Measure Information:
Title
Change From Baseline for Yeaple Probe
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
10 Minutes
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
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, 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 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:
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 orthodontic appliances
Facility Information:
Facility Name
Silverstone Research Group
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
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