This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste (NCT04964063), a na na study. The primary outcome is Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04964063 |
| Phase | NA |
| Condition | Dentin Sensitivity |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 655 |
| Arms in the primary outcome | n/a |
| Lead sponsor | HALEON |
| Results posted | Yes |
2. Clinical Question
Population
Participants with dentin sensitivity are the population described in the registry record. The primary outcome is identified for the mITT Population. Eligibility details, participant characteristics, and the number included in that population are not reported in the registry record.
Intervention
The study evaluated Sensodyne Fresh Mint Toothpaste, identified in the intervention record as potassium nitrate plus sodium fluoride. The study summary describes use of an anti-sensitivity toothpaste for 24 weeks.
Comparator
There is no separate comparator group in this single-group study. The allocation is listed as NA, and the record flags that the study is not a randomized comparison. Baseline measurements are not a substitute for a concurrent control group.
Primary question
The listed primary outcome is the mean DHEQ Section 1 score for questions Q1-3 at Baseline (Day 0). The registry record describes the study purpose as evaluating change in oral health-related quality of life following toothpaste use, but a numerical change result is not reported in the registry record.
The study focuses on how dentine hypersensitivity relates to everyday life, as captured by the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The listed primary measure concerns the baseline score, rather than a comparison of change between treatment groups. Since the study has a single group, it does not directly estimate how outcomes would have differed under an alternative treatment or no study toothpaste.
The DHEQ questions cover the intensity of sensations, how bothered participants were by them, and how well they could tolerate them. The registry describes each question as scored on a scale from 1 to 10 and states that lower scores indicate better improvement in oral health-related quality of life. Baseline is defined as the Day 0 value. The baseline mean and standard deviation are not reported in the registry record, so the level and variability of the primary score cannot be assessed from these registry entries.
3. Trial Design
NCT04964063 is a completed, single-group real-world evidence study sponsored by HALEON. The record lists 655 participants as the enrollment. The study started on 2021-08-31, and its primary completion date is 2022-05-13. Its phase is listed as NA, allocation as NA, and masking as NONE. The study model is SINGLE GROUP.
Participants were to use Sensodyne Fresh Mint Toothpaste, identified as potassium nitrate plus sodium fluoride. The brief summary describes evaluating changes in oral health-related quality of life among participants with dentinal hypersensitivity symptoms following use of anti-sensitivity toothpaste for 24 weeks. The arm description refers to commercial tube instructions for sensitivity relief. The full details of those instructions and any additional study procedures are not reported in the registry record.
A single-group design describes observations in participants who received the study intervention, without a separate concurrent comparison group. As a result, the design can describe participants’ recorded outcomes but cannot by itself separate changes associated with toothpaste use from changes that might occur over time for other reasons. The registry record explicitly flags that the study is not a randomized comparison and that its arms are not a like-for-like control comparison.
The listed primary outcome is a mean DHEQ Section 1 score at Baseline (Day 0), while the study purpose refers to change following use over 24 weeks. The baseline score’s numerical result is not reported in the registry record, and a numerical change result is not reported in the registry record. The number of participants who completed follow-up, the duration of follow-up assessments beyond the summary’s 24-week description, and reasons for any missing measurements are not reported in the registry record.
The record lists 63 outcome measures and 66 analyses. Those counts indicate that many measures and analyses are recorded, but they do not establish which results were confirmatory, how analyses were prioritized, or whether adjustments were made for multiple testing. A detailed statistical analysis plan, eligibility criteria, and sample-size justification are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 801 participants were screened, 655 were enrolled, and 557 completed the study. A total of 98 participants discontinued the study.
Overall Study
| Stage | Sensodyne Fresh Mint Toothpaste |
|---|---|
| STARTED | 655 |
| COMPLETED | 557 |
| NOT COMPLETED | 98 |
Reasons for not completing this period:
| Reason | Sensodyne Fresh Mint Toothpaste |
|---|---|
| Adverse Event | 4 |
| Lost to Follow-up | 47 |
| Withdrawal by Subject | 5 |
| Baseline Tasks Expired | 41 |
| Participant withdrawn in error | 1 |
Analysis population for the primary outcome, as defined in the registry: mITT Population
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The modified Intent-To-Treat (mITT) population included all participants who had received at least one dose of study product and have at least one post baseline Dentine Hypersensitivity Experience Questionnaire (DHEQ)-48 questionnaire data.
| Characteristic | Unit | Sensodyne Fresh Mint Toothpaste |
|---|---|---|
| Participants analysed | 577 | |
| Age, Continuous | years | 35.84 (SD 10.875) |
| Sex: Female, Male: Female | Participants | 446 |
| Sex: Female, Male: Male | Participants | 131 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 86 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 483 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 8 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 6 |
| Race (NIH/OMB): Asian | Participants | 63 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 118 |
| Race (NIH/OMB): White | Participants | 353 |
| Race (NIH/OMB): More than one race | Participants | 13 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0), measured over Baseline (Day 0).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome is the mean score for DHEQ Section 1, questions Q1-3, at Baseline (Day 0). Section 1 concerns sensitive teeth and the impact they have on participants’ everyday life. The questions ask participants to rate the intensity of sensations, how bothered they were by sensations, and how well they could tolerate them. Each question uses a scale from 1 to 10, with descriptions ranging from not at all intense to worst imaginable, not at all bothered to extremely bothered, and can easily tolerate to cannot tolerate at all.
The measure is intended to capture participants’ experience of dentine hypersensitivity in terms that include both symptoms and their everyday-life impact. Patient-reported measures can describe experiences that may not be captured by clinical observations alone. That is a general explanation of why such measures are used; it does not establish the measure’s performance in this study.
The registry states that lower scores indicate better improvement in oral health-related quality of life. However, the listed primary outcome is a baseline value, not a reported change from baseline. The numerical mean and standard deviation are not reported in the registry record. Nor is a numerical result for change at a later assessment reported in the registry record. Thus, the endpoint description identifies what was intended to be measured, but does not establish the observed score or its change after toothpaste use.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed study with 655 participants enrolled and a single study group using Sensodyne Fresh Mint Toothpaste. Its stated purpose was to evaluate changes in oral health-related quality of life following 24 weeks of use. The primary outcome listed in the record, however, is the mean DHEQ Section 1 score at Baseline (Day 0). This distinction matters: a baseline score describes participants’ starting measurement, while a change outcome requires measurements at more than one time point and a defined method for comparing them.
The numerical baseline mean and standard deviation are not reported in the registry record. A numerical result for change in the primary measure is also not reported in the registry record. Consequently, the posted information described by these registry entries does not establish the magnitude or precision of any change in DHEQ score. The study’s purpose statement alone is not an outcome estimate.
The single-group design also limits what can be inferred. Without a concurrent comparator, an observed before-and-after difference, if available, would describe change among participants in the study but would not directly show what would have happened to comparable participants without the intervention or under another intervention. General influences on measurements over time can include natural variation, changes in reporting, or other events. These are general considerations, not findings about this study.
The registry lists an mITT Population for the primary outcome, but the population size and the operational definition of mITT are not reported in the registry record. Enrollment is not necessarily the same as the number contributing to a particular analysis. Without the analyzed count and missing-data information, the extent to which the primary analysis represents all enrolled participants cannot be determined.
The record reports adverse-event counts for 584 participants at risk in the study group: 2 with serious adverse events and 41 with other adverse events; deaths are listed as 0. These are descriptive counts in the registry record. They do not, by themselves, establish that an event was caused by the toothpaste or that the observed counts would be higher or lower than under a comparator.
Overall, the record identifies a patient-reported measure and describes the intended study purpose, but the primary numerical outcome needed to judge the observed score and its precision is not reported in the registry record. No treatment-effect conclusion can be drawn from a baseline endpoint description alone.
9. Statistical Methods Explained
What does a mean score describe?
For a continuous measure such as a questionnaire score, the mean is a summary of the observed scores across the participants included in an analysis. It gives a central value, but it does not show how scores are distributed or whether participants’ experiences were similar. The primary outcome is described as a mean, with standard deviation as its dispersion measure. Neither the numerical mean nor the standard deviation is reported in the registry record.
The standard deviation describes how spread out individual scores are around the mean. A larger spread indicates more variability among participant scores, while a smaller spread indicates that scores are more concentrated. This is a general interpretation of standard deviation, not a statement about the unreported study result. The standard deviation is not the same as the uncertainty in the estimated mean.
How would a confidence interval help?
In general, a confidence interval gives a range of values compatible with the data and the method used to estimate the quantity. It helps readers judge precision: a narrower interval indicates a more precise estimate under the statistical model, whereas a wider interval indicates greater uncertainty. It does not guarantee that the true value lies within that particular interval, and it does not by itself establish clinical importance.
A confidence interval for the primary mean or for a change estimate is not reported in the registry record. The mean and standard deviation needed to understand the listed baseline outcome are also not reported. Therefore, the precision of the primary result cannot be assessed from these registry entries.
Why does the single-group design matter?
In a single-group study, the main observations come from participants who received the study intervention. If outcomes are measured at baseline and later, a within-group change can be described. That change is not the same as a treatment-versus-control effect. A control group can help account for changes that might have occurred over the same period without the intervention, although design and analysis choices still affect interpretation.
The registry identifies this as a single-group study and flags that it is not a randomized comparison. There is no like-for-like control group described in the registry record. Accordingly, even if a follow-up change were reported, the design would not directly estimate a randomized contrast against another group. A numerical follow-up change is not reported in the registry record.
What can the listed analysis population tell readers?
The primary outcome is assigned to the mITT Population. In general, an analysis population defines which participants’ data are included in a particular analysis. The acronym alone does not reveal the exact inclusion rules used in this study. Those rules and the number analyzed are not reported in the registry record. The enrolled total of 655 should therefore not be treated as the number contributing to the primary outcome without the analysis count.
Missing measurements can affect a mean or change estimate if participants with unavailable data differ from those whose measurements are observed. General methods for addressing missing data include analyzing observed cases or using modeled or imputed values, but those approaches rely on different assumptions. The method used for this study is not reported in the registry record. No missingness count or explanation is reported in the registry record.
How should significance and planning illustrations be read?
A p-value, when reported, describes how compatible the observed data are with a specified statistical model and a null hypothesis. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A p-value for the primary outcome is not reported in the registry record. The record also does not report a statistical analysis plan, so the planned inferential tests and decision rules cannot be identified.
The record describes sample-size planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect, and that illustrations for time-to-event outcomes use total events while other illustrations use participants per arm. These are planning assumptions, not a description of the single-group study’s enrollment process. Such illustrations are not observed power and do not show that an analysis had a particular probability of detecting an effect. The trial’s own sample-size justification is not reported in the registry record.
More generally, over-dispersion means that observed variability exceeds what a model assumes. If present, it can make standard errors too small under a model that does not account for the extra variability. This is a general statistical consideration; whether it is relevant to any analysis in this study is not reported in the registry record.
What does the number of analyses imply?
The registry lists 63 outcome measures and 66 analyses. When many outcomes or analyses are examined, the chance of finding an apparently notable result by chance can increase. Multiplicity methods can address this issue, but whether an adjustment is needed depends on which results were intended to be confirmatory and how analyses were planned. The registry record does not report the multiplicity strategy, any hierarchy of outcomes, or which analyses were prespecified. The counts alone do not establish that a particular correction was or was not used.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 63 outcome measures and 66 analyses. With multiple outcomes or analyses, interpreting isolated findings can be difficult because repeated testing can increase the chance of apparently noteworthy results arising by chance. Statistical approaches can control or describe this concern, but their appropriateness depends on the analysis plan and the role of each outcome. A multiplicity strategy, outcome hierarchy, or distinction between confirmatory and exploratory analyses is not reported in the registry record.
The primary outcome is assigned to the mITT Population. The exact definition of that population and its size are not reported in the registry record. The enrolled count of 655 does not establish how many participants contributed data to this specific analysis. The adverse-event group separately lists 584 participants at risk; that count should not be assumed to be the primary analysis population.
Missing-data handling is not reported in the registry record. The number of participants with missing primary outcome measurements, reasons for missingness, and any assumptions or methods used to handle unavailable data are also not reported in the registry record. In general, missingness can affect interpretation if the availability of a measurement is related to a participant’s score or experience. Different approaches to missing data make different assumptions, so knowing the method and the analysis population is important for judging robustness.
The study purpose describes evaluation of change over 24 weeks, but the listed primary measure is a baseline score. A later measurement schedule and a numerical change analysis are not reported in the registry record. Without those details, the relation between the stated change objective and the listed primary outcome cannot be fully assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | 2 | 584 | 0.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sensodyne Fresh Mint Toothpaste | 0 of 584 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sensodyne Fresh Mint Toothpaste | 41 of 584 |
Most frequent serious adverse event terms
| Event term | Organ system | Sensodyne Fresh Mint Toothpaste |
|---|---|---|
| Head Injury | Injury, poisoning and procedural complications | 1 of 584 |
| Syncope | Nervous system disorders | 1 of 584 |
| Anxiety | Psychiatric disorders | 1 of 584 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sensodyne Fresh Mint Toothpaste |
|---|---|---|
| Covid-19 | Infections and infestations | 11 of 584 |
| Cheilitis | Gastrointestinal disorders | 3 of 584 |
| Nasopharyngitis | Infections and infestations | 2 of 584 |
| Sinusitis | Infections and infestations | 2 of 584 |
| Attention Deficit Hyperactivity Disorder | Psychiatric disorders | 2 of 584 |
| Insomnia | Psychiatric disorders | 2 of 584 |
| Post-Traumatic Stress Disorder | Psychiatric disorders | 2 of 584 |
| Dental Caries | Gastrointestinal disorders | 2 of 584 |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | 2 of 584 |
| Hyperaesthesia Teeth | Gastrointestinal disorders | 2 of 584 |
Serious events with the highest arm-level rate: head injury (0.2%), syncope (0.2%), anxiety (0.2%).
The registry record lists 584 participants at risk in the Sensodyne Fresh Mint Toothpaste group. It reports 2 participants affected by serious adverse events, 41 affected by other adverse events, and 0 deaths. These are registry-record counts, and the group’s at-risk count is the denominator listed for the adverse-event information. The terms reported among the most frequent serious adverse events are Head Injury, Syncope, and Anxiety, each listed as 0.2%.
These figures describe events recorded in the study; they do not establish that the toothpaste caused an event. A serious adverse event is a category of event severity, not a conclusion about causality. The registry record does not provide a comparator group for estimating how the event counts would differ under another condition. It also does not provide the event-level narratives or attribution details in the registry record.
The serious-event count and the count for other adverse events refer to separate categories in the registry record. The listed counts should not be combined or interpreted as a comparative risk estimate. The observed figures alone also do not establish that an event is absent when no event is listed. They describe the safety information recorded for this single-group study, with no randomized control comparison described.
12. What the Result Does, and Does Not, Mean
The record establishes that NCT04964063 was a completed, single-group study with 655 participants enrolled and that it evaluated use of Sensodyne Fresh Mint Toothpaste in the context of dentine sensitivity. Its summary states that the study aimed to evaluate changes in oral health-related quality of life following 24 weeks of use. The primary outcome listed is the mean DHEQ Section 1 score at Baseline (Day 0).
The DHEQ endpoint description explains what the score is intended to capture: intensity of sensations, how bothered participants were, and tolerance of sensations in everyday life. It also states that lower scores indicate better improvement in oral health-related quality of life. But the primary baseline mean and its standard deviation are not reported in the registry record. A numerical change result is not reported in the registry record either. The description therefore clarifies the measurement, not the observed outcome.
The study’s single-group structure means that it does not provide a randomized comparison with a separate control group. In general, a change observed within a group cannot by itself distinguish an intervention-related change from other changes over time. This is a limitation of the design, not evidence for or against a particular outcome.
The adverse-event information reports 2 serious adverse events, 41 other adverse events, and 0 deaths among 584 participants at risk. These counts provide a descriptive account of the registry-record safety data. In the absence of a comparator and event attribution details, they do not establish whether events were caused by the intervention or how counts compare with another treatment or with no intervention.
Thus, the available record details describe the study’s purpose, design, outcome definition, and adverse-event counts, but do not report the numerical primary score or change needed to assess the stated quality-of-life objective. They support no conclusion about the size or precision of an outcome change.
13. Why This Trial Matters Statistically
This study illustrates why the definition of an endpoint and its numerical result need to be read together. The registry identifies a patient-reported DHEQ score and explains its everyday-life focus, but the listed primary measure is at baseline. The study purpose concerns change following 24 weeks of use. Without a reported follow-up result or change estimate, the objective and the primary outcome entry do not provide a numerical account of change.
It also demonstrates the interpretive limits of a single-group design. A within-group description can be useful for characterizing participants’ recorded experiences, but it does not provide a randomized comparison against another group. That distinction matters when readers ask whether an observed change can be attributed to an intervention rather than to other influences over time. The registry record itself flags that this is not a randomized comparison.
The listing of 63 outcome measures and 66 analyses makes transparency about analysis choices relevant. Readers need to know which outcomes were prioritized, which analyses were prespecified, and whether multiplicity was addressed to understand the evidential weight of results. Those details are not reported in the registry record. Similarly, the mITT label does not identify the analysis population’s size or exact definition.
Finally, registry-record safety counts are informative as descriptions but are not comparative estimates. The serious and other adverse-event counts are reported for 584 participants at risk, without a separate control group in the study design details. The distinction between descriptive monitoring and comparative inference is central to reading these data cautiously.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting the stated quality-of-life objective is that the numerical baseline mean and standard deviation are not reported in the registry record, and no numerical change result is reported in the registry record. The listed primary outcome is a baseline measure, while the study summary describes evaluating change after 24 weeks. The relationship between the listed endpoint and the stated change objective is therefore not fully resolved by the record details.
The study is single-group, with allocation listed as NA and masking as NONE. The registry explicitly flags that it is not a randomized comparison. There is no concurrent comparator described in the registry record, which limits causal interpretation of any within-group change that might be available elsewhere. Participant eligibility criteria, demographic characteristics, and the number completing follow-up are not reported in the registry record.
The primary outcome is assigned to the mITT Population, but the population’s size and definition are not reported in the registry record. The method for handling missing measurements, the amount of missing data, and reasons for missingness are also not reported. These details matter because the observed analysis population may differ from the enrolled population.
The registry lists 63 outcome measures and 66 analyses, but does not report a statistical analysis plan, multiplicity strategy, or outcome hierarchy in the registry record. The study’s sample-size justification is not reported in the registry record. Planning illustrations are not a substitute for the study’s own design justification, nor are they observed power.
The adverse-event information is descriptive and comes from a single study group. Event attribution and comparative safety information are not reported in the registry record. These limitations restrict conclusions to what the design and posted figures can describe.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste — NCT04964063.
- Registry record last updated 2024-01-22; status last verified 2023-04.
- Results first posted 2024-01-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04964063 is a completed, HALEON-sponsored, single-group study of Sensodyne Fresh Mint Toothpaste, identified as potassium nitrate plus sodium fluoride, among participants with dentin sensitivity. The registry lists enrollment of 655, a start date of 2021-08-31, and a primary completion date of 2022-05-13. The study summary describes evaluating oral health-related quality of life following use for 24 weeks.
The listed primary outcome is the mean DHEQ Section 1 score for Q1-3 at Baseline (Day 0), in the mITT Population. The numerical mean, standard deviation, and a numerical change result are not reported in the registry record. The record lists 63 outcome measures and 66 analyses; the statistical analysis plan, multiplicity approach, and missing-data methods are not reported in the registry record.
For the toothpaste group, the record lists 584 participants at risk, 2 with serious adverse events, 41 with other adverse events, and 0 deaths. The study design does not include a randomized comparison group in the registry record described.