A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.

Official Title
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A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Device: Dipotassium oxalate toothpaste
* Drug: Stannous fluoride toothpaste
* Drug: Potassium nitrate toothpaste
* Drug: Sodium monofluorophosphate toothpaste


Participation Criteria
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Eligibility Criteria
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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; sign a Confidentiality Disclosure Agreement (CDA); 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*; exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); have an absence of extensive calculus above the gum line; agree to return for all scheduled visits and follow study procedures; and have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.) Exclusion Criteria: having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically; chronic medical debilitating disease associated with constant or intermittent episodes of daily pain; any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit; dental prophylaxis within 2 weeks prior to Baseline visit; having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit; having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months; having teeth or periodontium with pathology or defects likely to cause pain; having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics; self-reported pregnancy or lactation; having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity; history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients; any diseases or condition that might interfere with the safe participation in the study; inability to undergo study procedures; having severe xerostomia; having had active caries within the 12 months; having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion; teeth will be excluded from study measurements if they: have deep, defective, or facial restorations; have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis; present with tendency for spontaneous bleeding; have been scaled/root planed or restored within the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed stannous fluoride toothpaste<br>Brush twice daily | Drug: Stannous fluoride toothpaste<br>* Marketed stannous fluoride (0.454%) toothpaste<br>|
| Active Comparator: Marketed potassium nitrate toothpaste<br>Brush Twice Daily | Drug: Potassium nitrate toothpaste<br>* Marketed potassium nitrate (5%) toothpaste<br>|
| Placebo Comparator: Marketed sodium monofluorophosphate toothpaste<br>Brush Twice Daily | Drug: Sodium monofluorophosphate toothpaste<br>* Marketed sodium monofluorophosphate (0.76%) toothpaste<br>|
| Experimental: Experimental dipotassium oxalate toothpaste<br>Brush Twice Daily | Device: Dipotassium oxalate toothpaste<br>* Experimental dipotassium oxalate (3%) toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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 least square mean will be calculated for this measure. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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. | Baseline | 
| Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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 least square mean will be calculated for this measure. | 3 days | 
| Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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 least square mean will be calculated for this measure. | 2 weeks | 
| Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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 least square mean will be calculated for this measure. | 8 weeks | 
| Air Challenge | The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record 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 least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11). | 11 weeks | 
| Baseline Yeaple Probe | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. | Baseline | 
| Tactile Threshold | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. | 3 days | 
| Tactile Threshold | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. | 2 weeks | 
| Tactile Threshold | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. | 4 weeks | 
| Tactile Threshold | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. | 8 weeks | 
| Tactile Threshold | Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11). | 11 weeks |