Dentin SensitivityNCT06733285
Clinical Study to Investigate the Ability of a Stannous Fluoride Toothpaste to Protect From Dentine Hypersensitivity
A study testing Sensodyne Rapid Relief and Colgate Cavity Protection in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.
Trial 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])… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Sensodyne Rapid Relief and Colgate Cavity Protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2025to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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:
- Exposed dentine due to facial/cervical erosion or abrasion (that is, tooth wear) or gingival recession (EAR).
- Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine (that is, the test area only).
- Clinical mobility= 0.
- Clinically confirmed DH to both tactile and evaporative (air) stimuli: Tactile threshold less than or equal to (<=) 20g and Schiff sensitivity score more than or equal to (>=) 2.
- Baseline (Visit 2)
- 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).
- Tactile threshold <= 20g at Screening and Baseline.
- Schiff sensitivity score >= 2 at Screening and Baseline.
- 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.
Who cannot join
- 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).
Show all 36Show fewer
- 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).
- Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1).
- Baseline (Visit 2): 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-sensitizing 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 has had orthodontic treatment (fixed or removable orthodontic braces/bands) within 6 months of Screening (Visit 1).
- Participant with a fixed or removable orthodontic retainer which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes (for example, participant who is an intermittent user of a removable orthodontic retainer). Note: Teeth involved in a fixed orthodontic retainer may be used as 'test teeth' if, in the opinion of the investigator or dentally qualified designee, their selection would not impact study outcomes.
- Specific Dentition Exclusions for 'Test teeth':
- Tooth with evidence of current/recent dental caries.
- Tooth having had (self-reported) treatment for dental caries within 12 months of Screening (Visit 1).
- Tooth with exposed dentine and deep, defective, or facial restorations.
- Tooth with a full crown or veneer.
- Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- Sensitive tooth with contributing etiologies other than EAR to exposed dentine.
- Sensitive tooth not expected to benefit from use of a sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
- Participants who, in the opinion of the investigator or designee, are unable to provide appropriate responses to the Labelled Magnitude Scale (LMS) training questions.
- Participants who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bristol, Bristol Dental School and Hospital
Bristol, BS1 2LY
About this study
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.
Read the 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).
- Conditions
- Dentin Sensitivity
- Being tested
- Sensodyne Rapid Relief, Colgate Cavity Protection
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensodyne Rapid ReliefDrug
Toothpaste containing 0.454 % weight/weight (w/w) SnF2 (1100 parts per million [ppm] fluoride).
Colgate Cavity ProtectionDrug
A regular fluoride toothpaste containing 1000 ppm fluoride.
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | 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. Receives: Drug: Sensodyne Rapid Relief |
| Regular Fluoride Toothpaste (Negative Control) | Active comparator | 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. Receives: Drug: Colgate Cavity Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Square (LS) Mean Change From Baseline in Schiff Sensitivity Score at Day 15
Evaporative (air) sensitivity was assessed by the participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated as Day 15 score minus Baseline score. A decreased Schiff Sensitivity Score indicated an improvement.
Measured: Baseline (Day 1) and Day 15
LS Mean Change From Baseline in Tactile Threshold at Day 15
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g(gram) and at Day 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the Tactile Threshold. The greater the Tactile Threshold, the less sensitive the tooth. The average Tactile Threshold value for the two 'test teeth' identified at Baseline was calculated. Change from Baseline was calculated as Day 15 value minus Baseline value.
Measured: Baseline (Day 1) and Day 15
Schiff Sensitivity Score at Baseline, Day 2, Day 8, and Day 15
Evaporative (air) sensitivity was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. A decreased Schiff Sensitivity Score indicated an improvement.
Measured: Baseline (Day 1), Days 2, 8 and 15
Tactile Threshold at Baseline, Day 2, Day 8, and Day 15
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2, 8 and 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the Tactile Threshold. The greater the Tactile Threshold, the less sensitive the tooth. The average Tactile Threshold value for the two 'test teeth' identified at Baseline was calculated.
Measured: Baseline (Day 1), Days 2, 8 and 15
Change From Baseline in Schiff Sensitivity Score at Day 2, Day 8, and Day 15
Evaporative (air) sensitivity was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated by subtracting Baseline score from the score at the indicated timepoints. A decreased Schiff Sensitivity Score indicated an improvement.
Measured: Baseline (Day 1), Days 2, 8 and 15
Change From Baseline in Tactile Threshold at Day 2, Day 8, and Day 15
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2, Day 8, and Day 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was 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 was calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: Baseline (Day 1), Days 2, 8 and 15
Secondary outcomes (4)
LS Mean Change From Baseline in Schiff Sensitivity Score at Day 2 and Day 8
Evaporative (air) sensitivity was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated by subtracting Baseline score from the score at the indicated timepoints. A decreased Schiff Sensitivity Score indicated an improvement.
Measured: Baseline (Day 1), Days 2 and 8
LS Mean Change From Baseline in Tactile Threshold (g) at Day 2 and Day 8
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2 and Day 8, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was 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 was calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: 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 Vs Negative Control)
Evaporative (air) sensitivity was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated by subtracting Baseline score from the score at the indicated timepoints. A decreased Schiff Sensitivity Score indicated an improvement.
Measured: 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)
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2, Day 8 and Day 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was 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 was calculated by subtracting Baseline score from the score at the indicated timepoints.
Measured: Baseline (Day 1), Days 2, 8 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Feb 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733285
- Sponsor's protocol ID
- 300212
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2024
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate the Ability of a Stannous Fluoride Toothpaste to Protect From Dentine Hypersensitivity
- ClinicalTrials.gov ID
- NCT06733285
- Acronym / sponsor ID
- 300212
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Posted 19 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Drug: Sensodyne Rapid ReliefParticipants 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. |
| Regular Fluoride Toothpaste (Negative Control) | Active comparator | Drug: Colgate Cavity ProtectionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (36 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensodyne Rapid ReliefToothpaste containing 0.454 % weight/weight (w/w) SnF2 (1100 parts per million [ppm] fluoride). | Drug | Test Toothpaste |
| Colgate Cavity ProtectionA regular fluoride toothpaste containing 1000 ppm fluoride. | Drug | Regular Fluoride Toothpaste (Negative Control) |
Primary outcome
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 was assessed by the participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated as Day 15 score minus Baseline score. A decreased Schiff Sensitivity Score indicated an improvement.
LS Mean Change From Baseline in Tactile Threshold at Day 15
Time frame: Baseline (Day 1) and Day 15
The Tactile sensitivity was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g(gram) and at Day 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the Tactile Threshold. The greater the Tactile Threshold, the less sensitive the tooth. The average Tactile Threshold value for the two 'test teeth' identified at Baseline was calculated. Change from Baseline was calculated as Day 15 value minus Baseline value.
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 was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. A decreased Schiff Sensitivity Score indicated 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 was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2, 8 and 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the Tactile Threshold. The greater the Tactile Threshold, the less sensitive the tooth. The average Tactile Threshold value for the two 'test teeth' identified at Baseline was calculated.
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 was assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. The participant's response was scored using Schiff Sensitivity Scale, which 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 and 3=Responded to stimulus, considered stimulus to be painful and requested discontinuation of the stimulus. The Schiff Sensitivity Score was average score of the 2 'test teeth' identified at Baseline. Change from Baseline was calculated by subtracting Baseline score from the score at the indicated timepoints. A decreased Schiff Sensitivity Score indicated 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 was assessed by administrating a constant pressure using a Yeaple probe. At Baseline, the upper test limit was 20 g and at Day 2, Day 8, and Day 15, the upper test limit was 80 g. The Tactile Threshold was defined as the maximum pressure applied without the participant reporting pain or discomfort. The Tactile Threshold for 2 selected test teeth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was 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 was calculated by subtracting Baseline score from the score at the indicated timepoints.
4 secondary outcomes
LS Mean Change From Baseline in Schiff Sensitivity Score at Day 2 and Day 8
Time frame: Baseline (Day 1), Days 2 and 8
LS Mean Change From Baseline in Tactile Threshold (g) at Day 2 and Day 8
Time frame: 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 Vs Negative Control)
Time frame: 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)
Time frame: Baseline (Day 1), Days 2, 8 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensodyne Rapid Relief and Colgate Cavity Protection in people with Dentin Sensitivity, run by HALEON at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Least Square (LS) Mean Change From Baseline in Schiff Sensitivity Score at Day 15 (time frame: Baseline (Day 1) and Day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.