Dentin SensitivityPhase 4NCT06608368

A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

A Phase 4 study testing Test Dentifrice (Sensodyne Repair and Protect Original Mint) and Reference Dentifrice (Crest Cavity Protection Regular) in people with Dentin Sensitivity, run by HALEON at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent (%) NovaMin (Calcium Sodium Phosphosilicate) to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5% potassium nitrate (KNO3) and a marketed regular fluoride-containing… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Sensitivity
What is being tested?: Test Dentifrice (Sensodyne Repair and Protect Original Mint) and Reference Dentifrice (Crest Cavity Protection Regular)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteCanada
Study dates: 7 Oct 2024to 15 Nov 2024
Phase: Phase 4
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.
Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Participant who wishes and is able to undergo at-home peroxide tooth bleaching.
Participant with generally good oral health that fulfil all of the following:

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Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
At least a total of 11 of the facial surfaces of maxillary and mandibular anterior 6 teeth (tooth numbers 6-11 and 22-27) suitable for peroxide whitening and gradable for VITA Bleachedguide evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact tooth bleaching performance or study evaluations as judged by the clinical examiner.
A minimum of 16 natural teeth.

Who cannot join

Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 60 days prior to study entry and/or during study participation.
Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
Participant who is pregnant or intending to become pregnant over the duration of the study or who is breastfeeding.
Participant with known or suspected intolerance or hypersensitivity to the study materials [including the peroxide whitening gel] (or closely related compounds) or any of their stated ingredients.
Participant who, in the opinion of the investigator or medically qualified designee, has a condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.

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Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
Participant with a recent history (within the last year) of alcohol or other substance abuse.
Participant with gross periodontal disease or who has had treatment for periodontal disease (including surgery) within 12 months of Screening or who has had scaling or root planning within 3 months of Screening.
Participant who has had a tooth bleaching procedure (either professionally dispensed or at home) within 12 months of Screening.
Participant with a fixed or removable partial prosthesis, multiple dental implants or orthodontic braces/bands or fixed retainer or togue/lip piercing which, in the opinion of the investigator, could impact study outcomes.
During the period from screening till 2 weeks post completion of tooth bleaching, participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
Participant who has previously been enrolled in this study.
Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
Participant who has had dental prophylaxis within 4 weeks of Screening or who requires antibiotic prophylaxis for dental procedures.

Trial locations and contacts

1 site in 1 country.

Canada1 site

All Sum Research
Mississauga, Ontario, L5N 6J2

Other trials in Canada

About this study

Official title: A Randomized, Controlled Clinical Study Assessing the Effects of a Marketed Dentifrice Compared to a Regular Fluoride Dentifrice and a Positive Control Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

Read the detailed description

This is a randomized, examiner blind, single-center, controlled, three arm, parallel group, proof-of-principal study to evaluate tooth sensitivity during and following a course of at-home tooth bleaching in participants with and without clinically confirmed dentine hypersensitivity (DH). The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 90 participants to study treatment (approximately 30 per treatment group).

Conditions: Dentin Sensitivity
Being tested: Test Dentifrice (Sensodyne Repair and Protect Original Mint), Positive Control Dentifrice (Sensodyne Fresh Mint), Reference Dentifrice (Crest Cavity Protection Regular)
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test Dentifrice (Sensodyne Repair and Protect Original Mint)Drug
Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.
Positive Control Dentifrice (Sensodyne Fresh Mint)Drug
Dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride.
Reference Dentifrice (Crest Cavity Protection Regular)Drug
Dentifrice containing 1100 ppm fluoride as sodium fluoride.

Study groups in NCT06608368
Study group	Role	What they receive
Test Dentifrice	Experimental	Participants will dose the toothbrush provided with a strip of test dentifrice containing 5% weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days. Receives: Drug: Test Dentifrice (Sensodyne Repair and Protect Original Mint)
Positive Control Dentifrice	Active comparator	Participants will dose the toothbrush provided with a strip of positive control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days. Receives: Drug: Positive Control Dentifrice (Sensodyne Fresh Mint)
Reference Dentifrice	Active comparator	Participants will dose the toothbrush provided with a strip of reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days. Receives: Drug: Reference Dentifrice (Crest Cavity Protection Regular)

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study
The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Up to Day 36
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the intensity of their tooth sensitivity using the individual 100 mm LMS for intensity. The scale was labelled with descriptive words related to intensity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the intensity of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Up to Day 36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the duration of their tooth sensitivity using the individual 100 mm LMS for duration. The scale was labelled with descriptive words related to duration and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the duration of sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Up to Day 36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for tolerability. The scale was labelled with descriptive words related to tolerability and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the tolerability of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Upto Day 36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for description. The scale was labelled with descriptive words related to the quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Up to Day 36
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study
The tooth sensitivity questionnaire including Bothersomeness NRS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they had been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.
Measured: Up to Day 36
Number of Participants With a Tooth Sensitivity-free Day Through the Study
Participants indicated whether they felt tooth sensitivity during the previous 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'No' response were reported.
Measured: Up to Day 36
Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity
Participants indicated whether they used any pain killing medications to relieve tooth sensitivity/pain in the last 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'Yes' response were to be reported.
Measured: Up to Day 36

Secondary outcomes (11)

Mean VAS Score During Tooth Bleaching
The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 mm VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Day 15 up to Day 21
Mean LMS Score During Tooth Bleaching
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Each individual scale was labelled with descriptive words related to the intensity, duration, tolerability, quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked each scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Day 15 up to Day 21
Mean Bothersomeness NRS Score During Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they were by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.
Measured: Day 15 up to Day 21
Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days during tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire were reported.
Measured: Day 15 up to Day 21
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days (derived for each participant) during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire were reported.
Measured: Day 15 up to Day 21
Mean VAS Score Post Completion of Tooth Bleaching
The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 mm VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Day 22 up to Day 36
Mean LMS Score Post Completion of Tooth Bleaching
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Each individual scale was labelled with descriptive words related to the intensity, duration, tolerability, quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked each scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Measured: Day 22 up to Day 36
Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they were by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.
Measured: Day 22 up to Day 36
Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days post completion of tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire were reported.
Measured: Day 22 up to Day 36
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching
The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days (derived for each participant) during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire were reported.
Measured: Day 22 up to Day 36
Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score
Tooth shade (color) of the facial surfaces of the anterior 6 maxillary and mandibular teeth were assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. VITA Bleachedguide 3D-MASTER uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide. Lower scores indicated an improvement.
Measured: Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202415 Nov 2024

First posted23 Sep 2024
Study start7 Oct 2024
Primary completion15 Nov 2024
Study completion15 Nov 2024

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06608368
Sponsor's protocol ID: 300106
Status last verified: Dec 2025
First submitted: 19 Sep 2024
Last updated: 15 Dec 2025
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Clinical Study Assessing the Effects of a Marketed Dentifrice Compared to a Regular Fluoride Dentifrice and a Positive Control Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching
ClinicalTrials.gov ID: NCT06608368
Acronym / sponsor ID: 300106
Conditions: Dentin Sensitivity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 7 Oct 2024 (actual)
Primary completion: 15 Nov 2024 (actual)
Study completion: 15 Nov 2024 (actual)
First posted: 23 Sep 2024 (actual)
Results: Posted 15 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Test Dentifrice	Experimental	Drug: Test Dentifrice (Sensodyne Repair and Protect Original Mint)Participants will dose the toothbrush provided with a strip of test dentifrice containing 5% weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.
Positive Control Dentifrice	Active comparator	Drug: Positive Control Dentifrice (Sensodyne Fresh Mint)Participants will dose the toothbrush provided with a strip of positive control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.
Reference Dentifrice	Active comparator	Drug: Reference Dentifrice (Crest Cavity Protection Regular)Participants will dose the toothbrush provided with a strip of reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.
Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Participant who wishes and is able to undergo at-home peroxide tooth bleaching.

Key exclusion criteria (16 listed)

Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 60 days prior to study entry and/or during study participation.
Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
Participant who is pregnant or intending to become pregnant over the duration of the study or who is breastfeeding.
Participant with known or suspected intolerance or hypersensitivity to the study materials [including the peroxide whitening gel] (or closely related compounds) or any of their stated ingredients.

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
Test Dentifrice (Sensodyne Repair and Protect Original Mint)Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.	Drug	Test Dentifrice
Positive Control Dentifrice (Sensodyne Fresh Mint)Dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride.	Drug	Positive Control Dentifrice
Reference Dentifrice (Crest Cavity Protection Regular)Dentifrice containing 1100 ppm fluoride as sodium fluoride.	Drug	Reference Dentifrice

Primary outcome

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study
Time frame: Up to Day 36
The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity
Time frame: Up to Day 36
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the intensity of their tooth sensitivity using the individual 100 mm LMS for intensity. The scale was labelled with descriptive words related to intensity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the intensity of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration
Time frame: Up to Day 36
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the duration of their tooth sensitivity using the individual 100 mm LMS for duration. The scale was labelled with descriptive words related to duration and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the duration of sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability
Time frame: Upto Day 36
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for tolerability. The scale was labelled with descriptive words related to tolerability and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the tolerability of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description
Time frame: Up to Day 36
The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for description. The scale was labelled with descriptive words related to the quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study
Time frame: Up to Day 36
The tooth sensitivity questionnaire including Bothersomeness NRS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they had been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.
Number of Participants With a Tooth Sensitivity-free Day Through the Study
Time frame: Up to Day 36
Participants indicated whether they felt tooth sensitivity during the previous 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'No' response were reported.
Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity
Time frame: Up to Day 36
Participants indicated whether they used any pain killing medications to relieve tooth sensitivity/pain in the last 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'Yes' response were to be reported.

11 secondary outcomes

Mean VAS Score During Tooth Bleaching
Time frame: Day 15 up to Day 21
Mean LMS Score During Tooth Bleaching
Time frame: Day 15 up to Day 21
Mean Bothersomeness NRS Score During Tooth Bleaching
Time frame: Day 15 up to Day 21
Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching
Time frame: Day 15 up to Day 21
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching
Time frame: Day 15 up to Day 21
Mean VAS Score Post Completion of Tooth Bleaching
Time frame: Day 22 up to Day 36
Mean LMS Score Post Completion of Tooth Bleaching
Time frame: Day 22 up to Day 36
Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching
Time frame: Day 22 up to Day 36
Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching
Time frame: Day 22 up to Day 36
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching
Time frame: Day 22 up to Day 36
Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score
Time frame: Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)

Results and safety

Results posted to the registry on 15 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Dentifrice (NovaMin Containing Dentifrice)	31	31
Positive Control Dentifrice (KNO3 Containing Dentifrice)	29	27
Reference Dentifrice (Regular Fluoride Dentifrice)	30	30

Primary outcome: Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study

Time frame: Up to Day 36. Mean (Standard Deviation). Unit: millimeter

Measure	Test Dentifrice (NovaMin Containing Dentifrice) n = 31	Positive Control Dentifrice (KNO3 Containing Dentifrice) n = 27	Reference Dentifrice (Regular Fluoride Dentifrice) n = 30
Screening	33.8 (37.00)	41.6 (38.71)	36.9 (38.73)
Baseline	31.1 (35.07)	36.9 (36.09)	36.5 (38.54)
Bleaching Period: Day 1	34.3 (34.24)	34.9 (35.35)	37.1 (38.72)
Bleaching Period: Day 2	38.0 (36.65)	35.9 (36.41)	36.2 (35.88)
Bleaching Period: Day 3	37.5 (35.54)	33.9 (36.08)	35.3 (32.54)
Bleaching Period: Day 4	39.7 (36.03)	36.1 (34.51)	39.7 (34.44)
Bleaching Period: Day 5	33.3 (35.66)	38.6 (34.52)	34.9 (35.00)
Bleaching Period: Day 6	34.0 (33.89)	37.7 (35.04)	33.9 (34.95)

Population analysed: Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one VAS score for tooth sensitivity recorded during the tooth-bleaching period. Only those participants with data available at the specified time point were analyzed.

Primary outcome: Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity

Time frame: Up to Day 36. Mean (Standard Deviation). Unit: millimeter

Measure	Test Dentifrice (NovaMin Containing Dentifrice) n = 31	Positive Control Dentifrice (KNO3 Containing Dentifrice) n = 27	Reference Dentifrice (Regular Fluoride Dentifrice) n = 30
Screening	28.1 (30.95)	38.8 (35.79)	32.6 (35.57)
Baseline	26.5 (29.76)	34.1 (33.49)	33.0 (36.02)
Bleaching Period: Day 1	29.7 (29.82)	33.3 (34.07)	31.6 (35.60)
Bleaching Period: Day 2	30.5 (30.83)	30.1 (31.85)	33.4 (33.14)
Bleaching Period: Day 3	30.0 (29.04)	29.4 (31.34)	33.3 (29.92)
Bleaching Period: Day 4	30.4 (29.13)	30.9 (28.96)	35.5 (30.36)
Bleaching Period: Day 5	25.9 (28.92)	31.7 (28.86)	29.2 (28.48)
Bleaching Period: Day 6	26.2 (26.59)	30.0 (27.68)	26.6 (27.06)

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

Primary outcome: LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration

Time frame: Up to Day 36. Mean (Standard Deviation). Unit: millimeter

Measure	Test Dentifrice (NovaMin Containing Dentifrice) n = 31	Positive Control Dentifrice (KNO3 Containing Dentifrice) n = 27	Reference Dentifrice (Regular Fluoride Dentifrice) n = 30
Screening	18.8 (21.55)	26.4 (25.30)	24.4 (26.28)
Baseline	18.0 (21.55)	23.0 (22.19)	24.6 (26.76)
Bleaching Period: Day 1	19.7 (22.14)	21.7 (21.33)	23.6 (25.56)
Bleaching Period: Day 2	23.5 (24.45)	20.7 (21.66)	26.6 (25.74)
Bleaching Period: Day 3	23.2 (22.58)	22.4 (23.66)	31.2 (25.29)
Bleaching Period: Day 4	23.9 (22.94)	26.0 (22.18)	29.7 (25.00)
Bleaching Period: Day 5	20.0 (21.96)	26.7 (23.24)	27.0 (25.43)
Bleaching Period: Day 6	23.5 (21.55)	28.7 (24.22)	25.9 (24.33)

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

Primary outcome: LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability

Time frame: Upto Day 36. Mean (Standard Deviation). Unit: millimeter

Measure	Test Dentifrice (NovaMin Containing Dentifrice) n = 31	Positive Control Dentifrice (KNO3 Containing Dentifrice) n = 27	Reference Dentifrice (Regular Fluoride Dentifrice) n = 30
Screening	20.7 (25.13)	21.9 (22.88)	19.9 (22.37)
Baseline	19.4 (24.84)	20.9 (22.56)	21.0 (23.95)
Baseline Period: Day 1	22.6 (24.42)	19.9 (22.93)	22.2 (24.50)
Baseline Period: Day 2	24.1 (27.44)	19.8 (22.66)	22.3 (23.68)
Baseline Period: Day 3	23.8 (25.83)	21.9 (24.65)	22.8 (21.55)
Baseline Period: Day 4	23.7 (25.87)	22.8 (22.54)	25.0 (22.96)
Baseline Period: Day 5	21.5 (25.25)	23.6 (22.85)	22.9 (23.81)
Baseline Period: Day 6	23.4 (24.18)	24.1 (24.53)	22.4 (23.49)

Population analysed: mITT population. Only those participants with data available at the specified time point were analyzed.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 41 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Dentifrice (NovaMin Containing Dentifrice)	0 of 31 (0%)	2 of 31 (6.5%)	0 of 31
Positive Control Dentifrice (KNO3 Containing Dentifrice)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Reference Dentifrice (Regular Fluoride Dentifrice)	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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?

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 9 inclusion and 16 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 15 Dec 2025. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). 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?

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study (time frame: Up to Day 36). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06608368.

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 15 Dec 2025.