A Comparison Study of Hypersensitivity Treatment

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control] in patients who have DHS. Participants will be asked to complete the following activities: Undergo a pre-treatment washout period for 3- to 6-weeks (± 4 days) post-enrollment. During this time, the Subject is to only use the provided oral hygiene products. Hypersensitivity will be assessed prior to (baseline) and immediately after sample application. Subject will be asked to come to the facility for hypersensitivity assessments at 24 hours, 7 days, and 30 days after the treatment visit. Researchers will compare 3M™ Clinpro™ Fluoride Aqueous Solution to 3M™ Vanish™ to evaluate if the effect of Clinpro™ on DHS treatment is non-inferior to Vanish™.

Detailed Description
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After Informed Consent has been obtained, the subjects will be given study supplied oral hygiene products (e.g., toothbrush and toothpaste) to be used immediately after the consent visit and throughout the entire duration of the study. Subjects will have a minimum wash-out period of 3 weeks followed by 1 treatment visit. At the treatment visit, a pain assessment will be performed (ie, a baseline pain score) in response to both an air-blast stimulus and tactile stimulus. After each stimulus, the Subject should score their pain using a Visual Analog Scale (VAS). After recording baseline pain scores, Clinpro™ (Treatment arm) or Vanish™ (Control arm) will be applied according to the manufacturer's IFU. Pain in response to air blast and probe test will be assessed using VAS immediately after application of fluoride treatment (within 15 minutes). Pain response will be assessed again at 24 h, 7 d, 21 d and 30 d post-application of the treatment.

Official Title
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Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity

Conditions
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Dentin Hypersensitivity

Intervention / Treatment
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* Device: 3M™ Clinpro™ Fluoride Aqueous Solution
* Device: 3M™ Vanish™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has at least one affected hypersensitive tooth upon air blast stimuli in the cervical area, and baseline pain score of 40 mm and above as assessed by the 100 mm VAS. Subject is at least 18 years old and have a minimum of 20 natural teeth. Subject is willing to withhold desensitizing treatment, including prescription, in-office or over the counter (OTC) desensitizing products, throughout the study period AND withhold during the washout period. Subject agrees to only use the provided toothpaste, toothbrush, and follows all oral hygiene instructions throughout the study period AND follows all oral hygiene instructions during the washout period. Subject is able to understand and willing to sign the Informed Consent, and is willing to return to the study facility for scheduled study visits and recalls. Exclusion Criteria: Subject has medical (including psychiatric) and pharmacotherapeutic histories that may compromise the protocol - including the chronic use of anti-inflammatory, analgesic (pain), and mind-altering drugs; or analgesic (pain) medications within 48 hours prior to application of treatment. Subject is pregnant (self-reported) or breast feeding. Subject has allergies to product ingredients, eg, rosin, mint flavoring. Subject has systemic conditions that are etiologic or predisposing to dentin hypersensitivity (eg, chronic acid regurgitation). Subject has excessive dietary or environmental exposure to acids at time of screening. Subject had periodontal treatment, bleaching treatments, or orthodontic treatments within previous 3 months or plans to have any other dental treatments during the study period. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study. Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria. Individual teeth may not be included that meet any of the following criteria: Study tooth has periodontal probing depth of ≥ 4 mm. Study tooth or the surrounding supporting tissue has any other painful pathology or defects. Study tooth has been restored in the preceding 3 months. Study tooth is an abutment for fixed or removable prostheses or suffers traumatic malocclusion. Study tooth is crowned or extensively restored and the restorations extending into the test area. The tooth has dentin hypersensitivity due to cracked enamel.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3M™ Clinpro™ Fluoride Aqueous Solution<br>Investigational product. | Device: 3M™ Clinpro™ Fluoride Aqueous Solution<br>* Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.<br>|
| Active Comparator: 3M™ Vanish™<br>Commercialized product | Device: 3M™ Vanish™<br>* Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain from baseline immediately after application of test product. | Sensitivity will be assessed using a 100-mm Visual Analog Scale (VAS) immediately after exposure to air stimulus. The VAS consists of a 100mm line, with two end points representing 0 (no pain) and 100 (worst pain). | Within 15 minutes post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain from baseline 24 hours post application of test product. | Sensitivity will be assessed using 100-mm VAS 24 hours after exposure to air stimulus. The VAS consists of a 100mm line, with two end points representing 0 (no pain) and 100 (worst pain). | 24 hours post-treatment | 
| Change in pain from baseline 7 days post application of test product. | Sensitivity will be assessed using 100-mm VAS 7 days after exposure to air stimulus. The VAS consists of a 100mm line, with two end points representing 0 (no pain) and 100 (worst pain). | 7 days post-treatment | 
| Change in pain from baseline 21 days post application of test product. | Sensitivity will be assessed using 100-mm VAS 21 days after exposure to air stimulus. The VAS consists of a 100mm line, with two end points representing 0 (no pain) and 100 (worst pain). | 21 days post-treatment | 
| Change in pain from baseline 30 days post application of test product. | Sensitivity will be assessed using 100-mm VAS 30 days after exposure to air stimulus. The VAS consists of a 100mm line, with two end points representing 0 (no pain) and 100 (worst pain). | 30 days post-treatment |