A Clinical Study to Evaluate the Anti-Sensitivity Effect... | NCT06378008

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: CSPS 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: Regular fluoride toothpaste (Crest Cavity Protection)

Name	Type	Description	Arm Group Labels	Other Names
CSPS toothpaste	Drug	Toothpaste containing 5.0% weight/weight (w/w) CSPS.	Test toothpaste

Outcomes Module

Primary Outcomes

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's 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 (Day 0) was calculated by subtracting Baseline score from Day 56 score. A negative change from Baseline indicated improvement.	Baseline (Day 0) and Day 56

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56	Tactile sensitivity was assessed for the 2 test teeth selected at Baseline by the examiner 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 dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the 2 'Test Teeth' selected at Baseline by the examiner. 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.

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 greater than or equal to (>=) 2.
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). a) Qualifying tactile threshold <= 20g at screening and baseline. b) Qualifying Schiff sensitivity score >= 2 at screening and baseline.

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 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
All Sum Research		Mississauga	Ontario	L5N 6J2	Canada

PubMed Identifier	Type	Citation	Retractions
42013973	Derived	Creeth J, Goyal CR, Qiu J, Lamptey M, Sanchez E, Qaqish J, Pereira PG. Time-course of clinical efficacy of a 5% calcium-sodium phosphosilicate toothpaste on dentine hypersensitivity. J Dent. 2026 Aug;171:106710. doi: 10.1016/j.jdent.2026.106710. Epub 2026 Apr 19.

ID	Title	Description
FG000	Test Toothpaste (Calcium Sodium Phosphosilicate [CSPS] Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5.0 percent [%] weight by weight [w/w] CSPS and 1040 parts per million [ppm] fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 6, 2024	Aug 19, 2025

ID	Title	Description
BG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
BG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000107 BG001108 BG002215

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

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's 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 (Day 0) was calculated by subtracting Baseline score from Day 56 score. A negative change from Baseline indicated improvement.

mITT population included all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline DH efficacy assessment.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0) and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

Units	Counts
Participants	OG000107 OG001108

Title

Denominators

Categories

Title	Measurements
	OG000-2.00± 0.065 OG001-0.20± 0.065

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	Change from Baseline at Day 56	Mixed Model with Repeated Measures		<0.0001		Adjusted Mean Difference	-1.80	Standard Error of the Mean	0.092	2-Sided	95	-1.98	-1.62			Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.		Superiority

Secondary

Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56

Tactile sensitivity was assessed for the 2 test teeth selected at Baseline by the examiner 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 dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the 2 'Test Teeth' selected at Baseline by the examiner. 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

grams

Baseline (Day 0) and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)

Secondary

Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 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's 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 2 'Test Teeth' selected at Baseline by examiner. Lower score=low degree of sensitivity. 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Days 3, 7, 14 and 28

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.

Secondary

Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28

mITT Population.

Posted

Least Squares Mean

Standard Error

grams

Baseline (Day 0), Days 3, 7, 14 and 28

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)

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

The DHEQ is a validated, condition-specific measure of Oral Health-Related Quality of Life (OHRQoL) in relation to DH. 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 score 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001

Secondary

Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56

DHEQ is a validated, condition-specific measure of OHRQoL in relation to DH. Section 2 of DHEQ included 34 questions grouped into 5 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 as sum of all questions (Q1 to Q34) score 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)

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 participant's teeth affected them 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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 participant's teeth had forced them 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. 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)

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. 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 the score at each indicated timepoint. A negative change from Baseline indicated improvement.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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. Lower score indicated less effect of sensations on participant's emotions. 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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 about overall health of participant's mouth, teeth, and gums. 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.

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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 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

mITT Population.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline (Day 0), Day 28 and Day 56

ID	Title	Description
OG000	Test Toothpaste (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
OG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.

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 (CSPS Toothpaste)	Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.	0	107	0	107	0	107
EG001	Reference Toothpaste (Regular Fluoride Toothpaste)	Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.	0	108	0	108	0	108