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The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
This study will be a single centre, randomised, 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 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Dentifrice | Experimental | Apply a full ribbon of toothpaste on the head of the toothbrush provided. Brush teeth for 1*-timed minute, followed by brushing of the qualifying sensitive teeth. Following brushing rinse once with 10 milliliter (ml) of water from the rinsing cup provided. |
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| Negative Control | Active Comparator | Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. |
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| Positive Control | Active Comparator | Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensodyne Sensitivity & Gum | Other | Sensodyne Sensitivity & Gum toothpaste containing 0.454% SnF2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control) | Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. |
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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 assessment is performed.
A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
A participant in good general 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.
A participant who presents the following oral and dental inclusions will apply at Screening (Visit 1):
i. Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
ii. Tooth with MGI score ≤1 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (<=)1.
iii. Tooth with signs of sensitivity measured by a qualifying tactile stimulus (yeaple [<=] 20 gram [g]) and qualifying evaporative air assessment (Schiff sensitivity score more than or equal to (>=) 2).
The following dental inclusions will apply at Baseline (Visit 2):
d) Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), with signs of sensitivity, measured by response to a qualifying tactile stimulus (yeaple <= 20g) and evaporative air assessment (Schiff sensitivity score >=2). The 2 selected 'test teeth' must have also qualified at Screening for this criteria.
- Participant must own a smartphone with the WeChat application installed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | Preventive Dentistry Depart-ment, Shanghai Ninth Peo-ple's Hospital, Shanghai Jiao-tong University, School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shanghai | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38530474 | Derived | Li R, Yang W, Grimaldi R, Zeng P, Smith G, Chen X. Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial. Clin Oral Investig. 2024 Mar 26;28(4):230. doi: 10.1007/s00784-024-05610-9. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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A total of 561 participates were screened, out of which 271 participants were enrolled and 197 participates were randomized to a treatment (66 participants in the test product group, 67 participants in the negative control dentifrice group and 64 participants in the positive control dentifrice group) and 196 participants subsequently completed the study; 1 participant did not complete the study from the test product group due to being lost to follow-up.
Participants were recruited from one center in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Dentifrice (Sensodyne Sensitivity & Gum) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 milliliters (mL) of water from the rinsing cup provided. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Dec 19, 2022 |
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| Crest Cavity Protection Fresh Lime | Other | Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride. |
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| Sensodyne Repair and Protect | Other | Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate. |
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| Baseline, Week 4 and 8 |
| Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | Baseline and Week 4 |
| Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | Baseline, Week 4 and Week 8 |
| Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control) | Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | Baseline, Week 4 and Week 8 |
| FG001 |
| Negative Control (Crest Cavity Protection Fresh Lime) |
Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. |
| FG002 | Positive Control (Sensodyne Repair and Protect) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. |
| COMPLETED |
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| NOT COMPLETED |
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Modified intent-to-treat (mITT) population, defined as all participants who are randomized, received at least one dose of the study treatments and provided at least one post-baseline assessment of efficacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Dentifrice (Sensodyne Sensitivity & Gum) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. |
| BG001 | Negative Control (Crest Cavity Protection Fresh Lime) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. |
| BG002 | Positive Control (Sensodyne Repair and Protect) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | mITT population | Posted | Mean | Standard Error | Score on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control) | Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Error | grams | Baseline, Week 4 and 8 |
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| Secondary | Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Error | Score on a scale | Baseline and Week 4 |
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| Secondary | Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control) | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was 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 was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | mITT population | Posted | Mean | Standard Error | score on a scale | Baseline, Week 4 and Week 8 |
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| Secondary | Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control) | Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. | mITT population | Posted | Mean | Standard Error | grams | Baseline, Week 4 and Week 8 |
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From start of screening until end of study (up to Day 57+/-3)
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Dentifrice (Sensodyne Sensitivity & Gum) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. | 0 | 66 | 1 | 66 | 18 | 66 |
| EG001 | Negative Control (Crest Cavity Protection Fresh Lime) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. | 0 | 67 | 0 | 67 | 3 | 67 |
| EG002 | Positive Control (Sensodyne Repair and Protect) | Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided. | 0 | 64 | 0 | 64 | 10 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstructive pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental abfraction | Gastrointestinal disorders | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Angular cheilitis | Gastrointestinal disorders | Systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | Systematic Assessment |
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| Oral blood blister | Gastrointestinal disorders | Systematic Assessment |
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| Gingival erythema | Gastrointestinal disorders | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | Systematic Assessment |
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| Lip injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pulpitis dental | Infections and infestations | Systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Keratitis | Eye disorders | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +44 7880 182593 | ww.clinical-trial-register@haleon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2021 | Dec 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
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