Dentin HypersensitivityNCT07297732
A Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Effectiveness of Two Experimental Toothpastes
A study testing Test Toothpaste 1, Test Toothpaste 2 and Reference Toothpaste in people with Dentin Hypersensitivity, run by HALEON at 1 site in United States.
Trial summary
The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Test Toothpaste 1, Test Toothpaste 2 and Reference Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent before any study procedures are performed.
- Participant is biologically male or female.
- Participant is 18 to 65 years of age, inclusive, at the time of signing the consent form.
- Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
- Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history (example, a medical condition confirmed to be causing xerostomia), 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.
- Participant must have History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported) and must have good general oral health, with a minimum of 20 natural teeth.
- Participant must have minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants
Who cannot join
- Participant is an employee of the study site directly involved in the conduct of the study, or an employee of the study 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 (self-reported) or intending to become pregnant during the study (self-reported) or who is who is breastfeeding (self-reported).
- Participant with known or suspected intolerance or hypersensitivity to any of the study products (Acclimatization Toothpaste or study toothpastes), 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 an investigational product (IP) within 30 days of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study (self-reported).
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- Participant has participated in a tooth sensitivity study within 8 weeks of Screening (Visit 1) (self-reported).
- Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-hypersensitivity oral care product within 8 weeks of Screening (Visit 1) (self-reported).
- Participant is currently using an oral care product primarily intended for tooth whitening benefits or has used such a product within 8 weeks of Screening (Visit 1) (self-reported).
- Participant has had professional tooth de-sensitizing treatment within 8 weeks of Screening (Visit 1) (self-reported).
- Participant is taking daily doses of medications/treatments (self-reported) which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
- Participant is taking daily doses of a medication (self-reported) which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
- Participant requires antibiotic prophylaxis for dental procedures (self-reported).
- Participant has had a tooth whitening procedure (professional or in-home treatment) within 12 months of Screening (Visit 1) (self-reported).
- Participant has had dental prophylaxis within 8 weeks of Screening (Visit 1) (self-reported).
- Participant has had treatment for periodontal disease (including surgery) within 12 months of Screening (Visit 1) (self-reported).
- Participant has had scaling or root planing within 3 months of Screening (Visit 1) (self-reported).
- Participant with, in the opinion of the investigator or medically qualified designee, gross periodontal disease.
- Participant with a tongue or lip piercing.
- Participant with, in the opinion of the investigator or medically qualified designee, evidence of gross intra-oral neglect or the need for extensive dental therapy.
- Participant with evidence of current/recent active dental caries or (self-reported) treatment for decay within 12 months of Screening (Visit 1).
- Participant with a fixed or removable partial prosthesis, multiple dental implants, fixed or removable orthodontic braces/bands and/or a fixed orthodontic retainer which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
- Specific dentition exclusions: For eligible teeth (DH assessment)
- Tooth with evidence of current/recent caries.
- Tooth with treatment for decay within 12 months of Screening (Visit 1) (self-reported).
- Tooth with exposed dentin 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 dentin.
- Sensitive tooth not expected to benefit from use of an anti-hypersensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
- Participant has taken antibiotics in the 2 weeks prior to Screening (Visit 1) (self-reported).
- Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the 2-week Acclimatization Period (self-reported).
- Participant has previously been enrolled in this study.
- Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Efficacy of Two Experimental Toothpastes
The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.
Read the detailed description
This will be a single center, randomized, controlled, examiner-blind, 3-treatment arm, stratified (Baseline mean VITA Bleached Guide 3D-MASTER score), parallel design, clinical study in healthy participants, aged 18-65 years inclusive, with sufficient tooth discoloration/surface stain to evaluate the whitening potential of the experimental formulations, and self-reported/clinically diagnosed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be randomized to one of three study toothpastes. Approximately 105 qualifying participants will be stratified and randomized to study treatment (approximately 35 participants per treatment group).
- Conditions
- Dentin Hypersensitivity
- Being tested
- Test Toothpaste 1, Test Toothpaste 2, Reference Toothpaste
- 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 Toothpaste 1Drug
Toothpaste containing Potassium nitrate
Test Toothpaste 2Drug
Toothpaste containing Potassium nitrate
Reference ToothpasteDrug
Regular fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste 1 | Experimental | Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 1 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. Receives: Drug: Test Toothpaste 1 |
| Test Toothpaste 2 | Experimental | Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 2 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. Receives: Drug: Test Toothpaste 2 |
| Reference Toothpaste | Active comparator | Participants will be instructed to brush the entire dentition thoroughly using Reference toothpaste for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. Receives: Drug: Reference Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean VITA Shade Score at Baseline, Weeks 1, 2, 4 and 8
Tooth color of the facial surfaces of the six anterior maxillary teeth will be visually assessed using the VITA Bleachedguide 3D-MASTER shade guide. It consists of a value-ranked ordered scale from 1 (lightest) to 29 (darkest). The shade of each assessable tooth surface/region will be scored by the clinical examiner with reference to the guide, where lower score indicates improvement.
Measured: Baseline, Weeks 1, 2, 4 and 8
Mean Total Modified Lobene Stain Index (MLSI) Score at Baseline, Weeks 1, 2, 4 and 8
Dental stain will be visually assessed for the facial surfaces of the teeth (incisors and canines) using the MLSI. For each tooth surface assessed, Area (A) and Intensity (I) of dental stain will be scored separately on the scale of 0 to 3 and the mean total score will be presented, where 0=Area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranging from 0 to 9, where lower score indicates improvement.
Measured: Baseline, Weeks 1, 2, 4 and 8
Secondary outcomes (2)
Schiff Sensitivity Score at Baseline, Week 4 and Week 8
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. The lower score indicates improvement.
Measured: Baseline, Week 4 and 8
Tactile Threshold at Baseline, Week 4 and Week 8
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.
Measured: Baseline, Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Dec 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297732
- Sponsor's protocol ID
- 300292
- Status last verified
- Mar 2026
- First submitted
- 9 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Investigate the Tooth Whitening and Dentin Hypersensitivity Efficacy of Two Experimental Toothpastes
- ClinicalTrials.gov ID
- NCT07297732
- Acronym / sponsor ID
- 300292
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.
Detailed description
This will be a single center, randomized, controlled, examiner-blind, 3-treatment arm, stratified (Baseline mean VITA Bleached Guide 3D-MASTER score), parallel design, clinical study in healthy participants, aged 18-65 years inclusive, with sufficient tooth discoloration/surface stain to evaluate the whitening potential of the experimental formulations, and self-reported/clinically diagnosed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be randomized to one of three study toothpastes. Approximately 105 qualifying participants will be stratified and randomized to study treatment (approximately 35 participants per treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste 1 | Experimental | Drug: Test Toothpaste 1Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 1 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Test Toothpaste 2 | Experimental | Drug: Test Toothpaste 2Participants will be instructed to brush the entire dentition thoroughly using Test toothpaste 2 for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. |
| Reference Toothpaste | Active comparator | Drug: Reference ToothpasteParticipants will be instructed to brush the entire dentition thoroughly using Reference toothpaste for 2-timed minutes, twice daily (morning and evening) for 8 weeks, making sure to brush all sensitive areas of the teeth. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of signed and dated informed consent before any study procedures are performed.
- Participant is biologically male or female.
- Participant is 18 to 65 years of age, inclusive, at the time of signing the consent form.
- Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
- Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history (example, a medical condition confirmed to be causing xerostomia), 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 (34 listed)
- Participant is an employee of the study site directly involved in the conduct of the study, or an employee of the study 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 (self-reported) or intending to become pregnant during the study (self-reported) or who is who is breastfeeding (self-reported).
- Participant with known or suspected intolerance or hypersensitivity to any of the study products (Acclimatization Toothpaste or study toothpastes), 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).
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 Toothpaste 1Toothpaste containing Potassium nitrate | Drug | Test Toothpaste 1 |
| Test Toothpaste 2Toothpaste containing Potassium nitrate | Drug | Test Toothpaste 2 |
| Reference ToothpasteRegular fluoride toothpaste | Drug | Reference Toothpaste |
Primary outcome
Mean VITA Shade Score at Baseline, Weeks 1, 2, 4 and 8
Time frame: Baseline, Weeks 1, 2, 4 and 8
Tooth color of the facial surfaces of the six anterior maxillary teeth will be visually assessed using the VITA Bleachedguide 3D-MASTER shade guide. It consists of a value-ranked ordered scale from 1 (lightest) to 29 (darkest). The shade of each assessable tooth surface/region will be scored by the clinical examiner with reference to the guide, where lower score indicates improvement.
Mean Total Modified Lobene Stain Index (MLSI) Score at Baseline, Weeks 1, 2, 4 and 8
Time frame: Baseline, Weeks 1, 2, 4 and 8
Dental stain will be visually assessed for the facial surfaces of the teeth (incisors and canines) using the MLSI. For each tooth surface assessed, Area (A) and Intensity (I) of dental stain will be scored separately on the scale of 0 to 3 and the mean total score will be presented, where 0=Area with no stain, 1=Stain covering up to one third of area and light intensity stain, 2=Stain covering up to two thirds of area and moderate intensity stain, 3=Stain covering more than two thirds of area and heavy intensity stain. Total MLSI score = Area score multiplied by Intensity score and ranging from 0 to 9, where lower score indicates improvement.
2 secondary outcomes
Schiff Sensitivity Score at Baseline, Week 4 and Week 8
Time frame: Baseline, Week 4 and 8
Tactile Threshold at Baseline, Week 4 and Week 8
Time frame: Baseline, Week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- 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 Test Toothpaste 1, Test Toothpaste 2 and Reference Toothpaste in people with Dentin Hypersensitivity, run by HALEON at 1 site in United States.
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 7 inclusion and 34 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 31 Mar 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean VITA Shade Score at Baseline, Weeks 1, 2, 4 and 8 (time frame: Baseline, Weeks 1, 2, 4 and 8). The study lists 2 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 31 Mar 2026.