Dentin Sensitivity
Conditions
Brief summary
The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.
Detailed description
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 a DH population. 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).
Interventions
Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.
Toothpaste containing 0.454 % weight/weight (w/w) SnF2
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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- 1. History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported). 2. Good general oral health, with a minimum of 20 natural teeth. 3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria: 1. Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR). 2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only). 3. Clinical mobility = 0 4. Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less than or equal to (\<=) 20g. b) Qualifying Schiff sensitivity score more than or equal to (\>=) 2. * Baseline (Visit 2, Pre-Treatment) 1. 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). 1. Qualifying tactile threshold \<= 20g at screening and baseline. 2. Qualifying Schiff sensitivity score \>= 2 at screening and baseline. 2. The clinical examiner will select two 'Test Teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both screening and baseline. Notes: All teeth with clinically confirmed, qualifying levels of DH at screening (that is, a screening tactile threshold \<= 20 g and a screening Schiff sensitivity score \>= 2) will be assessed for tactile sensitivity at baseline. Teeth with a baseline tactile threshold \<= 20g will then be assessed for baseline evaporative (air) sensitivity.
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': 1. Tooth with evidence of current/recent caries. 2. Tooth with (self-reported) treatment for decay within 12 months of screening (Visit 1). 3. Tooth with exposed dentin and deep, defective or facial restorations. 4. Tooth with a full crown or veneer. 5. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes. 6. Sensitive tooth with contributing etiologies other than EAR to exposed dentin. 7. Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 | Baseline and Day 56 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28 | Baseline and Day 28 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 28 score. A decrease in Schiff sensitivity score indicated an improvement. |
| Adjusted Mean Change From Baseline in Tactile Threshold at Day 28 | Baseline and Day 28 | Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram. 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 28 value. |
| Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Baseline, Day 28 and Day 56 | DHEQ section 1, questions 7-9 were about teeth sensation and its impact on 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). Thus, the total score ranged from 3 to 30; where the lower score indicated less sensitivity and less impact on everyday life. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | Baseline, Day 28 and Day 56 | The DHEQ was a condition-specific measure of Oral Health-related Quality of Life (OHrQoL) in relation to DH which consisted of a total of 34 questions in section 2 grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34), each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 34 to 238; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Restrictions domain in DHEQ evaluated the ways in which any sensations in teeth affected participant's daily life. This consisted of 4 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 4 to 28; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in Tactile Threshold at Day 56 | Baseline and Day 56 | Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram (g). 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 56 value. |
| Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Social Impact domain in DHEQ evaluated the way the sensations affected participants when they were with other people or in certain situations. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Emotional Impact Domain in DHEQ evaluated the way the sensations in participant's teeth made them feel. This consisted of 8 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 8 to 56; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Identity Domain in DHEQ evaluated what the sensations in participant's teeth meant for them. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Global Oral Health was evaluated using a single question which asked about the overall health of participant's mouth, teeth, and gums. The scale ranged from 1 (excellent) to 6 (Very poor), where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
| Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Baseline, Day 28 and Day 56 | Effect on life was evaluated using 4 questions which asked how much the sensations in teeth affected participant's life overall. The scale ranged from 0 (not at all) to 4 (Very much) and thus, the total score ranged from 0 to 16; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoint minus score at baseline. |
| Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Baseline, Day 28 and Day 56 | Adaptation domain in DHEQ evaluated 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This consisted of 12 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 12 to 84; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
A total of 126 participants were screened into the study, 111 participants were enrolled, 104 participants were randomized to a treatment (53 participants in the test toothpaste group and 51 participants in the reference toothpaste group) and 102 participants completed the study (51 participants in the test toothpaste group and 51 participants in the reference toothpaste group).
Participants by arm
| Arm | Count |
|---|---|
| Test Toothpaste Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to 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 wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided. | 53 |
| Reference Toothpaste (Negative Control) Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided. | 51 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Reference Toothpaste (Negative Control) | Total | Test Toothpaste |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 9.93 | 49.9 years STANDARD_DEVIATION 9.08 | 49.9 years STANDARD_DEVIATION 8.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 104 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 44 Participants | 90 Participants | 46 Participants |
| Sex: Female, Male Female | 43 Participants | 92 Participants | 49 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 |
| other Total, other adverse events | 5 / 53 | 4 / 51 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 |
Outcome results
Primary
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement.
Time frame: Baseline and Day 56
Population: Modified Intent-To-Treat (mITT) population included all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline dentin hypersensitivity (DH) efficacy assessment. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 | -2.25 score on a scale | Standard Error 0.08 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 | -0.31 score on a scale | Standard Error 0.08 |
p-value: <0.000195% CI: [-2.16, -1.72]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Adaptation domain in DHEQ evaluated 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This consisted of 12 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 12 to 84; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Day 28 | -6.45 score on a scale | Standard Error 1.6 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Day 56 | -12.42 score on a scale | Standard Error 2.53 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Day 28 | -1.73 score on a scale | Standard Error 1.396 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 | Day 56 | -3.31 score on a scale | Standard Error 1.726 |
Comparison: Day 28p-value: 0.078495% CI: [-8, 0.44]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.009295% CI: [-14.27, -2.07]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Emotional Impact Domain in DHEQ evaluated the way the sensations in participant's teeth made them feel. This consisted of 8 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 8 to 56; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Day 28 | -4.10 score on a scale | Standard Error 1.089 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Day 56 | -10.23 score on a scale | Standard Error 1.34 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Day 28 | -3.33 score on a scale | Standard Error 0.957 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 | Day 56 | -2.98 score on a scale | Standard Error 0.958 |
Comparison: Day 28p-value: 0.904795% CI: [-3.04, 2.69]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.000195% CI: [-9.95, -3.38]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Identity Domain in DHEQ evaluated what the sensations in participant's teeth meant for them. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Day 28 | -0.69 score on a scale | Standard Error 0.666 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Day 56 | -3.34 score on a scale | Standard Error 0.735 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Day 28 | -0.27 score on a scale | Standard Error 0.517 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 | Day 56 | -0.51 score on a scale | Standard Error 0.725 |
Comparison: Day 28p-value: 0.573395% CI: [-2.14, 1.19]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.00695% CI: [-4.92, -0.84]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Restrictions domain in DHEQ evaluated the ways in which any sensations in teeth affected participant's daily life. This consisted of 4 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 4 to 28; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Day 28 | -2.27 score on a scale | Standard Error 0.634 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Day 56 | -4.94 score on a scale | Standard Error 0.742 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Day 28 | -1.20 score on a scale | Standard Error 0.444 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 | Day 56 | -1.90 score on a scale | Standard Error 0.492 |
Comparison: Day 28p-value: 0.300395% CI: [-2.34, 0.73]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.002895% CI: [-4.56, -0.97]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Social Impact domain in DHEQ evaluated the way the sensations affected participants when they were with other people or in certain situations. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Day 28 | -1.23 score on a scale | Standard Error 0.644 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Day 56 | -3.63 score on a scale | Standard Error 0.771 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Day 28 | -0.94 score on a scale | Standard Error 0.552 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 | Day 56 | -0.24 score on a scale | Standard Error 0.587 |
Comparison: Day 28p-value: 0.868695% CI: [-1.82, 1.54]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.001295% CI: [-5.18, -1.31]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
The DHEQ was a condition-specific measure of Oral Health-related Quality of Life (OHrQoL) in relation to DH which consisted of a total of 34 questions in section 2 grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34), each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 34 to 238; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | Day 28 | -14.79 score on a scale | Standard Error 3.833 |
| Test Toothpaste | Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | Day 56 | -34.56 score on a scale | Standard Error 5.296 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | Day 28 | -7.47 score on a scale | Standard Error 2.678 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 | Day 56 | -8.94 score on a scale | Standard Error 3.394 |
Comparison: Day 28p-value: 0.188495% CI: [-15.46, 3.08]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.000295% CI: [-37, -11.97]Mixed Model with Repeated Measures
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 was evaluated using 4 questions which asked how much the sensations in teeth affected participant's life overall. The scale ranged from 0 (not at all) to 4 (Very much) and thus, the total score ranged from 0 to 16; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoint minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Day 28 | -0.80 score on a scale | Standard Error 0.253 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Day 56 | -1.93 score on a scale | Standard Error 0.277 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Day 28 | -0.53 score on a scale | Standard Error 0.311 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56 | Day 56 | -0.71 score on a scale | Standard Error 0.261 |
Comparison: Day 28p-value: 0.899695% CI: [-0.75, 0.85]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.020495% CI: [-1.66, -0.14]Mixed Model with Repeated Measures
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 which asked about the overall health of participant's mouth, teeth, and gums. The scale ranged from 1 (excellent) to 6 (Very poor), where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Day 28 | -0.15 score on a scale | Standard Error 0.076 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Day 56 | -0.23 score on a scale | Standard Error 0.082 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Day 28 | -0.10 score on a scale | Standard Error 0.1 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56 | Day 56 | -0.06 score on a scale | Standard Error 0.074 |
Comparison: Day 28p-value: 0.276895% CI: [-0.39, 0.11]Mixed Model with Repeated Measures
Comparison: Day 56p-value: 0.023295% CI: [-0.48, -0.04]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
DHEQ section 1, questions 7-9 were about teeth sensation and its impact on 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). Thus, the total score ranged from 3 to 30; where the lower score indicated less sensitivity and less impact on everyday life. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q7, Day 28 | -1.44 score on a scale | Standard Error 0.216 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q7, Day 56 | -2.83 score on a scale | Standard Error 0.217 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q8, Day 28 | -1.69 score on a scale | Standard Error 0.224 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q8, Day 56 | -3.04 score on a scale | Standard Error 0.222 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q9, Day 28 | -0.46 score on a scale | Standard Error 0.26 |
| Test Toothpaste | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q9, Day 56 | -1.96 score on a scale | Standard Error 0.26 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q9, Day 28 | -0.12 score on a scale | Standard Error 0.216 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q7, Day 28 | -0.61 score on a scale | Standard Error 0.199 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q8, Day 56 | -0.78 score on a scale | Standard Error 0.226 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q7, Day 56 | -0.71 score on a scale | Standard Error 0.225 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q9, Day 56 | -0.43 score on a scale | Standard Error 0.269 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 | Q8, Day 28 | -0.53 score on a scale | Standard Error 0.216 |
Comparison: Q7, Day 28p-value: 0.126895% CI: [-1.04, 0.13]Mixed Model with Repeated Measures
Comparison: Q7, Day 56p-value: <0.000195% CI: [-2.38, -1.13]Mixed Model with Repeated Measures
Comparison: Q8, Day 28p-value: 0.024595% CI: [-1.35, -0.09]Mixed Model with Repeated Measures
Comparison: Q8, Day 56p-value: <0.000195% CI: [-2.44, -1.18]Mixed Model with Repeated Measures
Comparison: Q9, Day 28p-value: 0.385195% CI: [-0.96, 0.37]Mixed Model with Repeated Measures
Comparison: Q9, Day 56p-value: 0.000295% CI: [-2.22, -0.73]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 28 score. A decrease in Schiff sensitivity score indicated an improvement.
Time frame: Baseline and Day 28
Population: mITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28 | -1.75 score on a scale | Standard Error 0.085 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28 | -0.10 score on a scale | Standard Error 0.086 |
p-value: <0.000195% CI: [-1.89, -1.41]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Tactile Threshold at Day 28
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram. 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 28 value.
Time frame: Baseline and Day 28
Population: mITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Tactile Threshold at Day 28 | 36.59 gram | Standard Error 3.009 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Tactile Threshold at Day 28 | 1.23 gram | Standard Error 3.038 |
p-value: <0.000195% CI: [26.88, 43.86]Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Tactile Threshold at Day 56
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram (g). 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 56 value.
Time frame: Baseline and Day 56
Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Toothpaste | Adjusted Mean Change From Baseline in Tactile Threshold at Day 56 | 60.07 gram | Standard Error 2.539 |
| Reference Toothpaste (Negative Control) | Adjusted Mean Change From Baseline in Tactile Threshold at Day 56 | 2.70 gram | Standard Error 2.544 |
p-value: <0.000195% CI: [50.23, 64.51]Mixed Model with Repeated Measures