A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Detailed Description
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This study will be a single center, randomized, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.

Official Title
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A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Drug: Sensodyne Sensitivity & Gum
* Drug: Crest Cavity Protection Fresh Lime
* Drug: Sensodyne Repair and Protect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any study procedures are performed. Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures. A participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. Participant who owns a smartphone with the WeChat application installed. A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1): Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire). Good general oral health, with a minimum of 20 natural teeth. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH. Each eligible tooth must meet all of the following criteria: Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR). Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only Clinical mobility = 0. DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to [<=] 20 g and Schiff sensitivity score more than or equal to [>=] 2). A participant who presents the following oral and dental inclusions will apply at Baseline (Visit 2): All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be reassessed for tactile sensitivity first; eligible teeth with Baseline tactile threshold <= 20g will then be re-assessed for evaporative (air) sensitivity. Participants must have a minimum of two non-adjacent, accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity: Tactile threshold <= 20 g at Screening and Baseline Schiff sensitivity score >= 2 at Screening and Baseline. VAS >= 40 mm at Baseline. The clinical examiner will select two 'test teeth' from those eligible teeth which meet the tactile threshold and Schiff sensitivity score criteria at both Screening and Baseline, and the VAS criterion at Baseline. Each test tooth must demonstrate a consistent DH response to the evaporative (air) stimulus at both Screening and Baseline: Screening Schiff sensitivity score = 2 and Baseline Schiff sensitivity score = 2 or Screening Schiff sensitivity score = 3 and Baseline Schiff sensitivity score = 3. Exclusion Criteria: Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family. Participant who has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1). Participant who is participating in, has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1). Participant who is using, or has used, an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1). Participant will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims. Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1). Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1). Participant who seen to rinse with water while brushing with the acclimatization toothpaste during review of their brushing compliance videos at Baseline (Visit 2). Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds). Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol. Female participant who is pregnant or intending to become pregnant during the study (self-reported). Female participant who is breastfeeding. Participant with a recent history (within the last year) of alcohol and/or substance abuse. Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood altering and anti-inflammatory drugs. Examples of herbal treatments include clove oil, olive oil or other treatments directly applied to the oral cavity for the treatment of oral health conditions. Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia. Participant who requires antibiotic prophylaxis for dental procedures. At Screening (Visit 1): participant who has taken antibiotics within 2 weeks of their Screening visit. At Baseline (Visit 2): participant who has taken antibiotics within 2 weeks of their Baseline visit (during the acclimatisation period). Participant who has had a professional or self-applied tooth bleaching procedure within 8 weeks of Screening (Visit 1). Participant who has had dental prophylaxis within 4 weeks of Screening (Visit 1). Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1). Participant who has had scaling or root planning within 3 months of Screening (Visit 1). Participant with a tongue or lip piercing. Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease. Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy. Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. Participant with multiple dental implants which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer. Participant with specific dentition exclusions for Test Teeth are as follows: Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening (Visit 1). Tooth with exposed dentin but with deep, defective or facial restorations. Tooth with full crown or veneer. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or medically qualified designee, would impact study outcomes. Sensitive tooth with contributing aetiologies other than erosion, abrasion or recession to exposed dentine. Sensitive tooth, in the opinion of the investigator or medically qualified designee, not expected to respond to treatment with an anti-sensitivity toothpaste. Participant who has previously been enrolled in this study. Any participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Test Dentifrice<br>Participants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Sensitivity & Gum. After brushing, participants will be instructed to rinse once with 10 milliliters (mL) of water using the measuring cup provided. | Drug: Sensodyne Sensitivity & Gum<br>* Sensodyne Sensitivity & Gum toothpaste is containing 0.454% w/w SnF2.<br>|
| Active Comparator: Negative Control<br>Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Crest Cavity Protection Fresh Lime. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided. | Drug: Crest Cavity Protection Fresh Lime<br>* Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).<br>|
| Active Comparator: Positive Control<br>Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Repair and Protect. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided. | Drug: Sensodyne Repair and Protect<br>* Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Schiff sensitivity score at Week 12 (Test Dentifrice Versus [vs.] Negative Control) | Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0 equal to (=) Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Schiff sensitivity score at Week 6 (Test Dentifrice vs. Negative Control) | Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in tactile threshold (g) at Week 6 (Test Dentifrice vs. Negative Control) | Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 6, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in VAS (mm) at Week 6 (Test Dentifrice vs. Negative Control) | Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented no discomfort and 100 represented the extreme discomfort (worst imaginable). Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in tactile threshold (grams [g]) at Week 12 (Test Dentifrice vs. Negative Control) | Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 12, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 | 
| Change from Baseline in VAS (millimeters [mm]) at Week 12 (Test Dentifrice vs. Negative Control) | Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented no discomfort and 100 represented the extreme discomfort (worst imaginable). Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 | 
| Change from Baseline in Schiff sensitivity score at Week 6 (Positive control vs. Negative Control) | Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in tactile threshold (g) at Week 6 (Positive control vs. Negative Control) | Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 6, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in VAS (mm) at Week 6 (Positive control vs. Negative Control) | Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented no discomfort and 100 represented the extreme discomfort (worst imaginable). Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 6 | 
| Change from Baseline in Schiff sensitivity score at Week 12 (Positive control vs. Negative Control) | Schiff sensitivity score will be assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant will be scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 | 
| Change from Baseline in tactile threshold (g) at Week 12 (Positive control vs. Negative Control) | Constant pressure will be administered using Yeaple Probe. At baseline the upper test limit is 20 g and at Week 12, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 | 
| Change from Baseline in VAS (mm) at Week 12 (Positive control vs. Negative Control) | Evaporative air sensitivity will be assessed by examiner as a response to a 1 second application of air from a standard air dental syringe applied to the exposed dentine surface of tooth approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Each participant rates the intensity of their response to the stimulus using a 100 mm VAS, where 0 represented no discomfort and 100 represented the extreme discomfort (worst imaginable). Higher score indicates worst outcome (more discomfort). Change from baseline is defined as post dose visit value minus baseline visit value. Baseline is defined as Day 1 (visit 2) value. | Baseline and Week 12 |