Clinical Study to Investigate the Ability of a Stannous Fluoride Toothpaste to Protect From Dentine Hypersensitivity
Overview
- Phase
- Not Applicable
- Intervention
- Sensodyne Rapid Relief
- Conditions
- Dentin Sensitivity
- Sponsor
- HALEON
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Least Square (LS) Mean Change from Baseline in Schiff Sensitivity Score at Day 15
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to investigate and characterize the Dentine Hypersensitivity (DH) protection profiles of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste and a regular fluoride toothpaste, in response to evaporative air (Schiff sensitivity score) and tactile (tactile threshold in grams [g]) stimuli, with twice daily brushing over 2 weeks.
Detailed Description
This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70 years, with self-reported and clinically confirmed DH. Participants who meet the required study criteria at screening and baseline will be randomized to one of two study toothpastes: 0.454% SnF2 toothpaste (Test) or a regular fluoride toothpaste (Negative Control). Sufficient participants will be screened to ensure approximately 80 participants are randomized to study toothpaste (approximately 40 participants per group) and approximately 70 participants complete the study (approximately 35 participants per group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
- •Participant is biologically male or female.
- •Participant is 18 to 70 years of age, inclusive, at the time of signing the consent form.
- •Participant is willing and able to comply with the study visit schedule, toothpaste 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, with 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)
- •Participants must have:
- •History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
- •Good general oral health, with a minimum of 20 natural teeth.
- •Minimum of 2 non-adjacent, accessible teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
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 such a product within 8 weeks of Screening (Visit 1).
- •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).
Arms & Interventions
Test Toothpaste
Participants will dose the toothbrush with a ribbon of test toothpaste, across the full brush head and brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for 2 weeks, making sure to brush the sensitive areas of the two 'test teeth' carefully first.
Intervention: Sensodyne Rapid Relief
Regular Fluoride Toothpaste (Negative Control)
Participants will dose the toothbrush with a ribbon of regular fluoride toothpaste, across the full brush head and brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for 2 weeks.
Intervention: Colgate Cavity Protection
Outcomes
Primary Outcomes
Least Square (LS) Mean Change from Baseline in Schiff Sensitivity Score at Day 15
Time Frame: Baseline (Day 1) and Day 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. LS means of change from baseline at Day 15 will be estimated using a Mixed Model with Repeated Measures (MMRM). A decrease in Schiff sensitivity score indicates an improvement.
LS Mean Change from Baseline in Tactile Threshold at Day 15
Time Frame: Baseline (Day 1) and Day 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. 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. LS means of change from baseline at Day 15 will be estimated using a MMRM.
Schiff Sensitivity Score at Baseline, Day 2, Day 8, and Day 15
Time Frame: Baseline (Day 1), Days 2, 8 and 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. A decrease in Schiff sensitivity score indicates an improvement.
Tactile Threshold at Baseline, Day 2, Day 8, and Day 15
Time Frame: Baseline (Day 1), Days 2, 8 and 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 2, 8 and 15, the upper test limit is 80 g. 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 in Schiff Sensitivity Score at Day 2, Day 8, and Day 15
Time Frame: Baseline (Day 1), Days 2, 8 and 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline will be calculated by subtracting baseline score from the score at the indicated timepoints. A decrease in Schiff sensitivity score indicates an improvement.
Change From Baseline in Tactile Threshold at Day 2, Day 8, and Day 15
Time Frame: Baseline (Day 1), Days 2, 8 and 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. 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 will be calculated by subtracting LS mean baseline score from the score at the indicated timepoints.
Secondary Outcomes
- LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2 and Day 8(Baseline (Day 1), Days 2 and 8)
- LS Mean Change from Baseline in Tactile Threshold (g) at Day 2 and Day 8(Baseline (Day 1), Days 2 and 8)
- LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2, Day 8 and Day 15 (Test Versus [Vs] Negative Control)(Baseline (Day 1), Days 2, 8 and 15)
- LS Mean Change from Baseline in Tactile Threshold (g) at Day 2, Day 8 and Day 15 (Test Vs Negative Control)(Baseline (Day 1), Days 2, 8 and 15)