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The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.
This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 0.454% SnF2 toothpaste in healthy participants with DH. The clinical efficacy of the 0.454% SnF2 toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 110 participants to investigational product (approximately 55 per treatment group) and to ensure approximately 100 evaluable participants complete the entire study (approximately 50 per treatment group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test toothpaste | Experimental | Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wish to rinse after brushing will be instructed to rinse with 10 milliliter (ml) water using graduated rinsing cup provided. |
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| Reference toothpaste (Negative control) | Active Comparator | Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wish to rinse after brushing will be instructed to rinse with 10 ml water using graduated rinsing cup provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride toothpaste | Drug | Toothpaste containing 0.454 % weight/weight (w/w) SnF2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 | Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 56 score. A negative change from Baseline indicated improvement in sensitivity. | Baseline (Day 0) and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56 | Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 56 value. A positive change from Baseline indicated improvement in sensitivity. |
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Inclusion Criteria:
Participant provision of signed and dated informed consent before any study procedures are performed.
Participant is male or female.
Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
Participant is 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 self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
Screening (Visit 1): Participant must have
History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
Good general oral health, with a minimum of 20 natural teeth.
Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:
Baseline (Visit 2, Pre-treatment): Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both Screening (Visit 1) and Baseline (Visit 2).
Exclusion Criteria:
Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
Female participant who is pregnant or intending to become pregnant during the study (self-reported).
Female participant who is breastfeeding (self-reported).
Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1).
Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of Screening (Visit 1). Participants will be required to bring their current oral care products to Screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
Baseline (Visit 2, Pre-treatment): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.
Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
Participant requires antibiotic prophylaxis for dental procedures.
Participant has had professional tooth de-sensitising treatment within 8 weeks of Screening (Visit 1).
Participant has had a tooth bleaching procedure within 8 weeks of Screening (Visit 1).
Participant has had dental prophylaxis within 4 weeks of Screening (Visit 1).
Participant has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1).
Participant has had scaling or root planning within 3 months of Screening (Visit 1).
Participant with gross periodontal disease.
Participant with a tongue or lip piercing.
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 dentally qualified designee, could impact study outcomes.
Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
Specific dentition exclusions for 'Test teeth':
Participant who, in the opinion of the investigator or designee, is unable to provide appropriate responses to the Labelled Magnitude Scale (LMS) training questions.
Participant has previously been enrolled in this study.
Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family and Cosmetic Dentistry, All Sums Research Center Ltd. | Melbourne | Florida | 32940 | United States |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
IPD will be made available within 6 months of publishing the results of the primary endpoints, 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 119 participants were screened of which 115 participants were enrolled, and 113 participants were randomized to receive treatment in 2 groups: Test Toothpaste group (57 participants) and Reference Toothpaste group (56 participants). 6 participants were not randomized (4 participants did not meet the study criteria, 2 participants withdrew consent). A total of 112 randomized participants completed the study.
This study was conducted at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Toothpaste (Stannous Fluoride Toothpaste) | Participants were instructed to apply a ribbon of test toothpaste containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first. |
| 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 7, 2024 | Jun 10, 2025 |
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| Regular fluoride toothpaste (Crest Cavity Protection) | Drug | Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride. |
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| Baseline (Day 0) and Day 56 |
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28 | Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 28 score. A negative change from Baseline indicated improvement in sensitivity. | Baseline (Day 0) and Day 28 |
| Adjusted Mean Change From Baseline in Tactile Threshold (g) at Day 28 | Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram (g) for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 28 value. A positive change from Baseline indicated an improvement in sensitivity. | Baseline (Day 0) and Day 28 |
| Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56 | The DHEQ is a condition-specific measure of Oral Health-Related Quality of Life (OHrQoL) used to investigate the impacts of tooth sensitivity on everyday life. DHEQ section 1, questions 7-9 were about participant's sensitive teeth and its impact on their everyday life. Participants scored Q7 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q8 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q9 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in sensitivity and its impact on everyday life. | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | The DHEQ is a condition-specific measure of OHrQoL used to investigate the impacts of tooth sensitivity on everyday life. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better OHrQoL. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL. | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life). | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life). | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Social impact domain of DHEQ evaluated 'the way the sensations affected participants when they were with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life). | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Emotional impact domain of DHEQ evaluated 'the way the sensations in participant's teeth made them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's emotions). | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Identity domain of DHEQ evaluated 'what the sensations in participant's teeth meant for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity). | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Global oral health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall oral health. | Baseline (Day 0), Day 28 and Day 56 |
| Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Effect on life overall was evaluated using 4 questions of DHEQ about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less impact of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's life overall). | Baseline (Day 0), Day 28 and Day 56 |
| FG001 | Reference Toothpaste (Regular Fluoride Toothpaste) | Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days. |
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Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one dose of study product and completed at least one post-baseline Dentin Hypersensitivity (DH) efficacy assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Toothpaste (Stannous Fluoride Toothpaste) | Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first. |
| BG001 | Reference Toothpaste (Regular Fluoride Toothpaste) | Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days. |
| BG002 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 | Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 56 score. A negative change from Baseline indicated improvement in sensitivity. | mITT Population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0) and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56 | Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 56 value. A positive change from Baseline indicated improvement in sensitivity. | mITT Population. | Posted | Mean | Standard Error | grams | Baseline (Day 0) and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28 | Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 28 score. A negative change from Baseline indicated improvement in sensitivity. | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0) and Day 28 |
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| Secondary | Adjusted Mean Change From Baseline in Tactile Threshold (g) at Day 28 | Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram (g) for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 28 value. A positive change from Baseline indicated an improvement in sensitivity. | mITT Population. | Posted | Mean | Standard Error | grams | Baseline (Day 0) and Day 28 |
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| Secondary | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56 | The DHEQ is a condition-specific measure of Oral Health-Related Quality of Life (OHrQoL) used to investigate the impacts of tooth sensitivity on everyday life. DHEQ section 1, questions 7-9 were about participant's sensitive teeth and its impact on their everyday life. Participants scored Q7 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q8 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q9 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in sensitivity and its impact on everyday life. | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | The DHEQ is a condition-specific measure of OHrQoL used to investigate the impacts of tooth sensitivity on everyday life. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better OHrQoL. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL. | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Social impact domain of DHEQ evaluated 'the way the sensations affected participants when they were with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Emotional impact domain of DHEQ evaluated 'the way the sensations in participant's teeth made them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's emotions). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Identity domain of DHEQ evaluated 'what the sensations in participant's teeth meant for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Global oral health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall oral health. | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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| Secondary | Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Effect on life overall was evaluated using 4 questions of DHEQ about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less impact of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's life overall). | mITT population. | Posted | Mean | Standard Error | score on a scale | Baseline (Day 0), Day 28 and Day 56 |
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From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 93 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including an acclimatization product (or medical device), whether or not considered related to the study product, including an acclimatization product (or medical device). A serious adverse event (SAE) was a particular category of AE where the adverse outcome was serious.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Test Toothpaste (Stannous Fluoride Toothpaste) | Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first. | 0 | 57 | 0 | 57 | 0 | 57 |
| EG001 | Reference Toothpaste (Regular Fluoride Toothpaste) | Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days. | 0 | 56 | 0 | 56 | 1 | 56 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SEASONAL ALLERGY | Immune system disorders | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | 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 | +441932959500 | ww.clinical-trial-register@haleon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2024 | Jun 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian - Central/South Asian Heritage |
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| Asian - East Asian Heritage |
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| White - White/Caucasian/European Heritage |
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Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
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| Reference Toothpaste (Regular Fluoride Toothpaste) |
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days. |
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Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
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| OG001 |
| Reference Toothpaste (Regular Fluoride Toothpaste) |
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days. |
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Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
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Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
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