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An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.
A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test dentifrice | Experimental | Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride |
|
| Comparator dentifrice | Active Comparator | Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium sodium phosphosilicate | Device | 5% w/w calcium sodium phosphosilicate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ellesmere Port | Cheshire | CH65 4BW | United Kingdom | ||
| GSK Investigational Site |
A total of 731 participants were screened, out of which 304 participants were randomized. 427 participants were not randomized because 377 did not met the study criteria, 1 had adverse event, 3 were lost to follow up and 1 due to protocol violation, 5 withdrew consent and 40 participants were not randomized because of other reasons (not specified).
Participants were recruited at one center (three sites) in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Dentifrice | Test dentifrice containing 5% weight by weight (w/w) calcium sodium phosphosilicate and 1426 parts per million (ppm) fluoride as sodium fluoride. |
| FG001 | Comparator Dentifrice | Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Dentifrice | Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride. |
| BG001 | Comparator Dentifrice | Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | Analysis for this outcome was performed on per protocol (PP) population which is defined as all participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violations. | Posted | Mean | Standard Deviation | score on a scale | At Baseline and Week 8 |
|
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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 | Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium fluoride | Other | 1426 ppm fluoride as sodium fluoride |
|
| Sodium monofluorophosphate | Other | 1426 ppm fluoride as sodium monofluorophosphate |
|
| At Baseline and Week 4 |
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline, Week 4 and Week 8 |
| Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | At Baseline, Week 4 and Week 8 |
| Maldon |
| Essex |
| CM9 5PN |
| United Kingdom |
| GSK Investigational Site | Metropolitan Borough of Wirral | CH41 6EY | United Kingdom |
| Withdrawal of Consent |
|
| Other (Not specified) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Test Dentifrice |
Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride. |
| OG001 | Comparator Dentifrice | Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate. |
|
|
|
| Secondary | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations. | Posted | Mean | Standard Deviation | score on a scale | At Baseline and Week 4 |
|
|
|
| Secondary | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, Week 4 and Week 8 |
|
|
|
| Secondary | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. | Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations. | Posted | Mean | Standard Deviation | gram (g) | At Baseline, Week 4 and Week 8 |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 51 |
| 150 |
| EG001 | Comparator Dentifrice | Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate. | 0 | 154 | 0 | 154 | 59 | 154 |
| Oral Herpes | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Influenza | Infections and infestations |
|
| Tonsillitis | Infections and infestations |
|
| Urinary Tract Infection | Infections and infestations |
|
| Ear Infection | Infections and infestations |
|
| Eye Infection | Infections and infestations |
|
| Hand-Foot-And-Mouth Disease | Infections and infestations |
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| Laryngitis | Infections and infestations |
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| Nail Infection | Infections and infestations |
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| Pharyngitis | Infections and infestations |
|
| Tooth Infection | Infections and infestations |
|
| Toothache | Gastrointestinal disorders |
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| Chapped Lips | Gastrointestinal disorders |
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| Aphthous Stomatitis | Gastrointestinal disorders |
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| Mouth ulceration | Gastrointestinal disorders |
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| Cheilitis | Gastrointestinal disorders |
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| Gingival Pain | Gastrointestinal disorders |
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| Lip Ulceration | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Oral discomfort | Gastrointestinal disorders |
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| Sensitivity of teeth | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Oral Mucosal Exfoliation | Gastrointestinal disorders |
|
| Gastritis | Gastrointestinal disorders |
|
| Oral Disorder | Gastrointestinal disorders |
|
| Oral Mucosal Erythema | Gastrointestinal disorders |
|
| Paraesthesia oral | Gastrointestinal disorders |
|
| Tongue Discolouration | Gastrointestinal disorders |
|
| Tongue Ulceration | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Migraine | Nervous system disorders |
|
| Lip Injury | Injury, poisoning and procedural complications |
|
| Tooth fracture | Injury, poisoning and procedural complications |
|
| Mouth injury | Injury, poisoning and procedural complications |
|
| Traumatic Ulcer | Injury, poisoning and procedural complications |
|
| Procedural Pain | Injury, poisoning and procedural complications |
|
| Fall | Injury, poisoning and procedural complications |
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| Head Injury | Injury, poisoning and procedural complications |
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| Laceration | Injury, poisoning and procedural complications |
|
| Ligament Sprain | Injury, poisoning and procedural complications |
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| Thermal Burn | Injury, poisoning and procedural complications |
|
| Device Failure | General disorders |
|
| Application Site Discomfort | General disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
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| Neck Pain | Musculoskeletal and connective tissue disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Ear Pain | Ear and labyrinth disorders |
|
| Depression | Psychiatric disorders |
|
| Dysmenorrhoea | Reproductive system and breast disorders |
|
| Urticaria | Skin and subcutaneous tissue disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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