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Dentin SensitivityNCT07300540

Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief

A study testing Calcium sodium phosphosilicate (CSPS) Toothpaste in people with Dentin Sensitivity, run by HALEON at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting. 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?
Calcium sodium phosphosilicate (CSPS) Toothpaste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
4 Mar 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 who has provided consent indicating they have been informed of all pertinent aspects of the study.
  • All genders who, at the time of screening, are aged 18 to 65.
  • Participant who is able to independently complete all activities on their smart devices
  • Participant who has tooth sensitivity (self-reported symptoms).

Who cannot join

  • Participants whose tooth sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
  • Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
  • Participant with full or partial denture.
  • Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
  • Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
  • Participants who have been informed by a DHCP that they have active caries.
  • Participant with any chronic and/or severe painful health condition which lead to regular use of pain relief medications (more than 3 days a week).
  • Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Citruslabs (Virtual Site)

    Las Vegas, Nevada, 89118

Other trials in United States

About this study

Official title: A Real-World Evidence Study Evaluating Oral Health Related Quality of Life With Use of a Calcium Sodium Phosphosilicate Anti-Sensitivity Dentifrice for Dentin Hypersensitivity Management

The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting.

Read the detailed description

This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms. OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participant. Sufficient numbers will be screened to enroll approximately 500 participants to ensure approximately 400 evaluable participants complete the entire study.

Being tested
Calcium sodium phosphosilicate (CSPS) 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.

  • Calcium sodium phosphosilicate (CSPS) ToothpasteOther

    A toothpaste containing 5% weight/weight (w/w) calcium sodium phosphosilicate.

Study groups in NCT07300540
Study groupRoleWhat they receive
Test ToothpasteOtherParticipants will be instructed to brush their teeth twice daily and not more than three times per day using test toothpaste, for 24 weeks.
Receives: Other: Calcium sodium phosphosilicate (CSPS) Toothpaste

What is being measured

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

  1. Change From Baseline in DHEQ Total Score at Week 24

    The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at Week 24.

    Measured: Baseline and Week 24

Secondary outcomes (20)
  1. Change From Baseline in DHEQ Restrictions Domain Score at Week 24

    Restrictions domain of DHEQ evaluates 'the ways in which any sensations in teeth affects participants in their daily life'. It includes 4 questions, each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree, resulting in a total score ranging from 4 to 28. A lower score indicates that sensations have less effect on daily life. Changes from a baseline will be calculated by subtracting the baseline score from the score at Week 24.

    Measured: Baseline and Week 24

  2. Change From Baseline in DHEQ Adaptation Domain Score at Week 24

    Adaptation domain of DHEQ evaluates 'the ways in which the sensations in teeth forces participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. It includes 12 questions, each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranges from 12 to 84, where lower score indicates less effect of sensations on participant's daily life. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

    Measured: Baseline and Week 24

  3. Change From Baseline in DHEQ Social Impact Domain Score at Week 24

    Social Impact domain of DHEQ assesses how sensations affect participants in social situations. It includes 5 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35. A lower score indicates less effect of sensations on participant's social life. Change from baseline is calculated by subtracting the baseline score from score at Week 24.

    Measured: Baseline and Week 24

  4. Change From Baseline in DHEQ Emotional Impact Domain Score at Week 24

    Emotional Impact Domain of DHEQ is used to assess the emotional impact of sensations in participant's teeth. It includes 8 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

    Measured: Baseline and Week 24

  5. Change From Baseline in DHEQ Identity Domain Score at Week 24

    Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them'. It includes 5 questions each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35, where lower score indicates less impact of sensations on participant's identity. Change from baseline is calculated by subtracting the baseline score from score at Week 24.

    Measured: Baseline and Week 24

  6. Change From Baseline in Impact on Everyday Life Score at Week 24

    Impact on Everyday Life section of DHEQ includes 3 questions about participant's sensitive teeth and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranges from 1 to 10; where lower scores indicate less intense, less bothersome and tolerable sensations. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

    Measured: Baseline and Week 24

  7. Change From Baseline in Global Oral Health Score at Week 24

    Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from baseline will be calculated by subtracting the baseline score from score at Week 24.

    Measured: Baseline and Week 24

  8. Change From Baseline in Effect on Life Overall Score at Week 24

    Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

    Measured: Baseline and Week 24

  9. Change From Baseline in Impact on Everyday Life Score at Weeks 4, 8, 12, 16, and 20

    Impact on Everyday Life section of DHEQ includes 3 questions about participant's sensitive teeth and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranges from 1 to 10; where lower scores indicate less intense, less bothersome and tolerable sensations. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  10. Change From Baseline in DHEQ Total Score at Weeks 4, 8, 12, 16, and 20

    The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  11. Change From Baseline in DHEQ Restrictions Domain Score at Weeks 4, 8, 12, 16, and 20

    Restrictions domain of DHEQ evaluates 'the ways in which any sensations in teeth affects participants in their daily life'. It includes 4 questions, each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree, resulting in a total score ranging from 4 to 28. A lower score indicates that sensations have less effect on daily life. Changes from a baseline will be calculated by subtracting the baseline score from the score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  12. Change From Baseline in DHEQ Adaptation Domain Score at Weeks 4, 8, 12, 16, and 20

    Adaptation domain of DHEQ evaluates 'the ways in which the sensations in teeth forces participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. It includes 12 questions, each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranges from 12 to 84, where lower score indicates less effect of sensations on participant's daily life. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  13. Change From Baseline in DHEQ Social Impact Domain Score at Weeks 4, 8, 12, 16, and 20

    Social Impact domain of DHEQ assesses how sensations affect participants in social situations. It includes 5 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35. A lower score indicates less effect of sensations on participant's social life. Change from baseline is calculated by subtracting the baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  14. Change From Baseline in DHEQ Emotional Impact Domain Score at Weeks 4, 8, 12, 16, and 20

    Emotional Impact Domain of DHEQ is used to assess the emotional impact of sensations in participant's teeth. It includes 8 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  15. Change From Baseline in DHEQ Identity Domain Score at Weeks 4, 8, 12, 16, and 20

    Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them'. It includes 5 questions each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35, where lower score indicates less impact of sensations on participant's identity. Change from baseline is calculated by subtracting the baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  16. Change From Baseline in Global Oral Health Score at Weeks 4, 8, 12, 16, and 20

    Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from baseline will be calculated by subtracting the baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  17. Change From Baseline in Effect on Life Overall Score at Weeks 4, 8, 12, 16, and 20

    Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20

  18. Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains at Baseline and Week 24

    The DHEQ is a condition-specific measure of OHrQoL in relation to DH. Five DHEQ domains include 34 questions grouped into separate domains: Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity. Participants will score each question using a 7-point scale ranging from 1(strongly disagree) to 7(strongly agree) where lower score indicates better quality of life in relation to DH. Scores 5 to 7 indicates agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree. Percentage of participants with scores 5 to 7 for each statement in the 5 DHEQ domains will be reported.

    Measured: Baseline and Week 24

  19. Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24

    NPRS is an 11-point segmented numeric version of a Visual Analogue Scale from which the participant will select a score from 0 to 10 that best reflected the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher score is an indication of greater pain intensity. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

    Measured: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  20. Satisfaction Numeric Rating Scale (NRS) Score at Week 24

    Participants will be asked to rate their satisfaction with the DH treatment using NRS. NRS is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the participant sought help from treatment. The score ranged from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate greater satisfaction with DH treatment.

    Measured: Week 24

Timeline

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

  1. First posted23 Dec 2025
  2. Study start4 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07300540
Sponsor's protocol ID
400303
Status last verified
Jul 2026
First submitted
10 Dec 2025
Last updated
21 Jul 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

Questions about this trial

What is this clinical trial studying?

A study testing Calcium sodium phosphosilicate (CSPS) Toothpaste in people with Dentin Sensitivity, 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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?

This study is still under way. Results are not available in the source record yet.

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?

Change From Baseline in DHEQ Total Score at Week 24 (time frame: Baseline and Week 24). 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 21 Jul 2026.

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