Dentin SensitivityNCT06045026

A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

A study testing Stannous fluoride in people with Dentin Sensitivity, run by HALEON at 1 site in United States.

Completed

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

Trial summary

This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dentin Sensitivity
What is being tested?: Stannous fluoride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 536 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2023to 25 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
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 between 18 and 65 years (inclusive).
Participant who is willing to complete all the assigned activities.
Participant who is able to independently complete all the assigned activities on their smart devices.
Participant who has tooth sensitivity (self-reported symptoms).

Who cannot join

Participant whose 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(s).
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.
Participant who has been informed by a DHCP that they have active caries.
Participant with any chronic and/or severe painful health condition(s) 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

ObvioHealth Virtual Site
New York, New York, 10001

Other trials in United States

About this study

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 over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.

Conditions: Dentin Sensitivity
Being tested: Stannous fluoride
Medical subject headings: Dentin Sensitivity

What participants receive

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

Stannous fluorideOther
Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride

Study groups in NCT06045026
Study group	Role	What they receive
Anti-sensitivity toothpaste	Other	Participants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks. Receives: Other: Stannous fluoride

What is being measured

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

Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
The DHEQ is a condition-specific measure of oral-health related quality-of-life (OHrQoL) in relation to dentin hypersensitivity (DH). Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). 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 was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better quality of life in relation to DH. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each 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 ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each 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 ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Social Impact domain of DHEQ evaluates 'the way the sensations affect participants when they are with other people or in certain situations.' It included 5 questions each 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 ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Emotional Impact Domain of DHEQ evaluated 'the way the sensations in participant's teeth make them feel.' It included 8 questions each 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 ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL (less impact of sensations on participant's emotions).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them.' It included 5 questions each 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 ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

Secondary outcomes (7)

Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
DHEQ Section 1 included 3 questions about participant's sensitive teeth and its impact on everyday life. Participants scored 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 ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in intensity, botheration and tolerability of sensations.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Global Oral Health was evaluated using a single question of DHEQ. Participants rated 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 indicated better oral health. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in global oral health.
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Effect on life was evaluated using 4 questions of DHEQ (Section 2, Q36-39) about how much the sensations in teeth affected participant's life overall. Participants scored 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 ranged from 0 to 16, where lower score indicated less effect of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall quality of life (less effect of sensations on participant's life overall).
Measured: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
The DHEQ is a condition-specific measure of OHrQoL in relation to DH. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1(strongly disagree) to 7(strongly agree) where lower score indicated better quality of life in relation to DH. Scores 5 to 7 indicated 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 were reported.
Measured: Baseline (Week 0) and Week 24
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
NPRS was an 11-point segmented numeric version of a Visual Analogue Scale from which the participant selected a score from 0 to 10 that best reflected the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores indicated of greater pain intensity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (reduction in pain intensity).
Measured: Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24
Satisfaction Numeric Rating Scale (NRS) Score at Week 24
Participants were 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 indicated greater satisfaction with DH treatment.
Measured: Week 24
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Participants described their oral hygiene habits by completion of an OHQ. It included 9 questions: Q1:How frequently do you normally brush your teeth? Q2:Have you had a professional or self-applied tooth whitening treatment in the last 2 weeks? Q3:Have you had a professional tooth cleaning in the last 2 weeks? Q4:Have you ever been diagnosed with sensitive teeth by a dentist? Q5: When was the last time you visited a dentist/hygienist? Q6:Do you use a toothpaste designed specifically for sensitive teeth? Q7:What brand of toothpaste do you most frequently use? Q8:What type of toothbrush do you use? Q9:Can you tell me if you have any of the following: Cracked tooth/ teeth Chipped tooth/teeth, Cold sores, Grinding teeth, Gum swelling/inflammation, Receding gums, Painful/tender gums when brushing, Ulcers in the mouth, Stained/yellow teeth, Seeing blood when you spit when you brush your teeth, Bad breath, None of these. Number of Participants with OHQ Responses at Baseline were reported.
Measured: Baseline (Week 0)

Timeline

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

21 Sep 202325 Apr 2024

First posted21 Sep 2023
Study start21 Sep 2023
Primary completion25 Apr 2024
Study completion25 Apr 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 536 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06045026
Sponsor's protocol ID: 300058
Status last verified: Apr 2025
First submitted: 13 Sep 2023
Last updated: 24 Apr 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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Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity

All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management
ClinicalTrials.gov ID: NCT06045026
Acronym / sponsor ID: 300058
Conditions: Dentin Sensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 536 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 21 Sep 2023 (actual)
Primary completion: 25 Apr 2024 (actual)
Study completion: 25 Apr 2024 (actual)
First posted: 21 Sep 2023 (actual)
Results: Posted 24 Apr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Anti-sensitivity toothpaste	Other	Other: Stannous fluorideParticipants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 between 18 and 65 years (inclusive).
Participant who is willing to complete all the assigned activities.
Participant who is able to independently complete all the assigned activities on their smart devices.
Participant who has tooth sensitivity (self-reported symptoms).

Key exclusion criteria (8 listed)

Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
Participant with known or suspected intolerance or hypersensitivity to the study materials (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
Stannous fluorideAnti-sensitivity toothpaste containing 0.454% Stannous Fluoride	Other	Anti-sensitivity toothpaste

Primary outcome

Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
The DHEQ is a condition-specific measure of oral-health related quality-of-life (OHrQoL) in relation to dentin hypersensitivity (DH). Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). 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 was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better quality of life in relation to DH. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each 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 ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each 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 ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Social Impact domain of DHEQ evaluates 'the way the sensations affect participants when they are with other people or in certain situations.' It included 5 questions each 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 ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Emotional Impact Domain of DHEQ evaluated 'the way the sensations in participant's teeth make them feel.' It included 8 questions each 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 ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL (less impact of sensations on participant's emotions).
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them.' It included 5 questions each 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 ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).

7 secondary outcomes

Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Time frame: Baseline (Week 0) and Week 24
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24
Satisfaction Numeric Rating Scale (NRS) Score at Week 24
Time frame: Week 24
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Time frame: Baseline (Week 0)

Results and safety

Results posted to the registry on 24 Apr 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
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)	536	460

Primary outcome: Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24

Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24. Mean (Standard Error). Unit: score on a scale

Measure	Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) n = 491
Change from Baseline at Week 4	-21.9 (1.52)
Change from Baseline at Week 8	-35.4 (1.72)
Change from Baseline at Week 12	-44.5 (1.94)
Change from Baseline at Week 16	-51.6 (2.05)
Change from Baseline at Week 20	-55.1 (2.12)
Change from Baseline at Week 24	-62.0 (2.20)

Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures

Population analysed: mITT population included all participants who completed at least one use of study product and had at least 1 post-baseline derived DHEQ total score. The Mixed Model with Repeated Measures (MMRM) included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.

Primary outcome: Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24

Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24. Mean (Standard Error). Unit: score on a scale

Measure	Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) n = 491
Change from Baseline at Week 4	-2.6 (0.20)
Change from Baseline at Week 8	-4.7 (0.24)
Change from Baseline at Week 12	-6.1 (0.27)
Change from Baseline at Week 16	-7.2 (0.28)
Change from Baseline at Week 20	-7.9 (0.29)
Change from Baseline at Week 24	-8.5 (0.30)

Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures

Population analysed: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.

Primary outcome: Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24

Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24. Mean (Standard Error). Unit: score on a scale

Measure	Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) n = 491
Change from Baseline at Week 4	-7.4 (0.58)
Change from Baseline at Week 8	-12.6 (0.66)
Change from Baseline at Week 12	-15.9 (0.73)
Change from Baseline at Week 16	-18.6 (0.77)
Change from Baseline at Week 20	-20.3 (0.79)
Change from Baseline at Week 24	-22.9 (0.83)

Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures

Primary outcome: Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24

Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24. Mean (Standard Error). Unit: score on a scale

Measure	Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) n = 491
Change from Baseline at Week 4	-2.9 (0.25)
Change from Baseline at Week 8	-4.6 (0.29)
Change from Baseline at Week 12	-5.7 (0.30)
Change from Baseline at Week 16	-6.6 (0.31)
Change from Baseline at Week 20	-7.2 (0.32)
Change from Baseline at Week 24	-8.1 (0.33)

Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect): p <0.0001, Mixed Model with Repeated Measures

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline (Week 0) up to Week 24 (up to approximately 168 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)	1 of 498 (0.2%)	42 of 498 (8.4%)	0 of 536

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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?

A study testing Stannous fluoride 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 5 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: finished, as of the sponsor's last update on 24 Apr 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 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?

Yes. Results are posted in the registry (first posted 24 Apr 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?

Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24 (time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06045026.

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 24 Apr 2025.