The primary purpose of this study is to demonstrate the clinical efficacy of Test Toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus, compared to a sodium fluoride reference toothpaste, after 8 weeks twice daily use.
Participant provision of signed and dated informed consent before any study procedures are performed.
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.
History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
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).
Parallel
Test Toothpaste
DeviceToothpaste containing 5.0 % weight/weight (w/w) CSPS.
Regular Fluoride Toothpaste
Other interventionRegular fluoride toothpaste.
Change from Baseline in Schiff Sensitivity Score at Week 8
Evaporative (air) sensitivity will be 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 will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 3, where 0 equal to (=) 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 will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Week 8 score. Lower score indicates improvement.
Change from Baseline in Tactile Threshold gram (g) at Week 8
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline is calculated by subtracting Baseline value from Week 8 value.
Change from Baseline in Schiff Sensitivity Score at Weeks 2 and 4
Evaporative (air) sensitivity will be 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 will be evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0 to 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 will be derived as mean score for the two 'Test Teeth' selected at Baseline by the examiner. Change from Baseline will be calculated by subtracting Baseline score from Weeks 2 and 4 scores. Lower score indicates improvement.
Change from Baseline in Tactile Threshold (g) at Weeks 2 and 4
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline is calculated by subtracting Baseline value from Week 2 and Week 4 values.
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