Clinical Study to Evaluate the Anti-sensitivity Efficacy... | NCT06359028

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.	Drug: Stannous fluoride toothpaste
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.	Drug: Crest cavity protection toothpaste

Name	Type	Description	Arm Group Labels	Other Names
Stannous fluoride toothpaste	Drug	Toothpaste containing 0.454 % weight/weight (w/w) SnF2	Test toothpaste

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline and Day 56

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Salus Research		Fort Wayne	Indiana	46825	United States

ID	Title	Description
FG000	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 milliliter (ml) water using the graduated rinsing cup provided.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 6, 2024	May 27, 2025

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00053 BG00151 BG002104

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

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.

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.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline and Day 56

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00051 OG00151

Title

Denominators

Categories

Title	Measurements
	OG000-2.25± 0.080 OG001-0.31± 0.080

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Model with Repeated Measures		<0.0001		Adjusted Mean Difference	-1.94	Standard Error of the Mean	0.113	2-Sided	95	-2.16	-1.72					Superiority

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

gram

Baseline and Day 56

ID	Title	Description
OG000	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.

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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline and Day 28

ID	Title	Description
OG000	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.
OG001

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.

mITT Population.

Posted

Least Squares Mean

Standard Error

gram

Baseline and Day 28

ID	Title	Description
OG000	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.
OG001

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	Reference Toothpaste (Negative Control)

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	Reference Toothpaste (Negative Control)

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

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.

mITT Population. Only those participants with data available at the specified time points were analyzed.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline, Day 28 and Day 56

ID	Title	Description
OG000	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.
OG001	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.

Term	Organ System	Assessment Type	Statistical Information
APHTHOUS ULCER	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0013 affected51 at risk
HYPERAESTHESIA TEETH	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0011 affected51 at risk
GLOSSODYNIA	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected51 at risk
LIP SWELLING	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected51 at risk
ORAL DISORDER	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected51 at risk
ORAL MUCOSAL EXFOLIATION	Gastrointestinal disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected51 at risk
DEHYDRATION	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected53 at risk EG0010 affected51 at risk

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	53	0	53	5	53
EG001	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.	0	51	0	51	4	51