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 Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP (NCT05258721), a na phase 2 study. The primary outcome is Changes in Modified Gingival Index (MGI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05258721 |
| Phase | Phase 2 |
| Condition | Gingivitis, Periodontitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rowpar Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with gingivitis or Stage I or II periodontitis. The registry lists an enrollment of 60.
Intervention
ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse, used twice daily as a regimen.
Comparator
No separate control group is described. The study is listed as single-group and self-controlled, with changes considered over time within participants.
Primary question
How did the Modified Gingival Index (MGI) change between baseline and 12 weeks during use of the toothpaste-and-rinse regimen?
The primary endpoint concerns the number of teeth meeting the registry’s definition of inflammation at each visit. The MGI scale rates gingival inflammation from 0 to 4; the endpoint description notes teeth with scores of >= 2 and analyzes the total number of affected teeth. The registry names the median and inter-quartile range as the summary measures.
This is a within-participant question rather than a randomized comparison between a treatment group and a control group. The design can describe how the measured endpoint differs across the scheduled visits, but by itself it cannot separate changes during the regimen from changes that might have occurred over time for other reasons. The registry record does not report the baseline or 12-week MGI values, the estimated change, or a statistical test of that change. It therefore does not establish the direction or size of the observed endpoint change.
3. Trial Design
The registry classifies this as a Phase 2, single-group study with no masking. Allocation is listed as NA, and the design is described as self-controlled, longitudinal, and non-blinded. The treatment group included participants with gingivitis or Stage I or II periodontitis. Participants were instructed to brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with ClōSYS® Sensitive Rinse twice daily after brushing.
The brief summary describes a 90-day trial measuring clinical parameters. The primary endpoint is assessed at baseline and 12 weeks. The registry lists an enrollment of 60, a start date of 2021-07-06, primary completion on 2022-10-31, and a completed status. These record details describe the study’s planned and administrative structure; they do not establish how many participants contributed measurements at each visit.
Because the study has one group and no separate control group, its central comparison is over time within participants. This structure is different from a randomized controlled trial, where concurrent groups can help account for time-related changes and other influences. No randomized comparison is described in the registry record.
Rowpar Pharmaceuticals, Inc. is listed as the sponsor. The registry lists four outcome measures and three analyses, but does not report a detailed statistical analysis plan or explain how those measures and analyses relate to one another. The protocol’s sample-size justification, any planned interim analyses, and further details of the analysis plan 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.
Overall Study
| Stage | Treatment Group |
|---|---|
| STARTED | 60 |
| COMPLETED | 52 |
| NOT COMPLETED | 8 |
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.
| Characteristic | Unit | Treatment Group |
|---|---|---|
| Participants analysed | 60 | |
| Age, Continuous | years | 66.2 (SD 8.8) |
| Sex: Female, Male: Female | Participants | 40 |
| Sex: Female, Male: Male | Participants | 20 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 56 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Changes in Modified Gingival Index (MGI), measured over Baseline and 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in the Modified Gingival Index (MGI) from baseline to 12 weeks. The MGI rating ranges from 0, indicating healthy gums, to 4, indicating the most severe inflammation. The endpoint description says that gingiva were visually examined on four surfaces for each tooth present, excluding third molars, for a total of 28 teeth. Teeth with inflammation affecting all portions of the gingival unit, described as a score of >= 2, were counted at each visit. The total number of affected teeth was evaluated for the final analysis.
The registry identifies the endpoint’s summary as a median with an inter-quartile range. In general, the median describes the middle of the observed values, while the inter-quartile range describes the spread of the central half. These summaries can be useful when values are not well represented by a mean and standard deviation, but the registry does not state why these particular summaries were selected.
The endpoint is intended to characterize gingival inflammation using a structured clinical assessment. The registry lists score ranges of 0-64 at baseline and 0-32 at 12 weeks. These are stated ranges, not observed participant results. The actual endpoint values and change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a clinical question and a measurement schedule, but it does not report the numerical primary endpoint results. No baseline or 12-week median, inter-quartile range, estimated change, confidence interval, or p-value for MGI is reported in the registry record. The direction, magnitude, and statistical precision of any change therefore cannot be assessed from the posted results described in the record.
The study’s single-group, self-controlled structure matters when interpreting any before-and-after measurements. A change between baseline and follow-up would describe the participants’ measurements over time while using the regimen. Without a concurrent control group, that change cannot by itself distinguish the regimen’s contribution from other influences, including natural variation, changes in behavior, or measurement variation. This is a general limitation of interpreting before-and-after observations, not a finding that any particular influence occurred in this study.
The registry lists an enrollment of 60, but that number does not show how many participants completed both assessments or were included in the primary analysis. The number with complete endpoint data, the analysis population, and the handling of missing measurements are not reported in the registry record. Those details are important for judging how representative the analyzed observations may be of the enrolled group.
The record reports zero serious adverse events and zero other adverse events in the treatment group, with 60 at risk for each category. These are the registry’s reported counts. They should be read as counts recorded in this study, not as proof that an event cannot occur or as a complete characterization of safety in other settings.
Overall, the record describes the intervention, endpoint, and study structure, but leaves the primary efficacy result unavailable. A statistical conclusion about the observed MGI change, including its precision or compatibility with no change, cannot be drawn from the information reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary endpoint as MGI change between baseline and 12 weeks and names the median and inter-quartile range as its summaries. It does not identify the statistical test, model, confidence-interval method, or other procedure used to analyze that endpoint. Those methods are not reported in the registry record, so the analysis cannot be reconstructed from the description alone.
What does a median describe?
In general, the median is the middle value after observations are ordered. It is less affected by unusually high or low observations than a mean can be. The inter-quartile range gives the interval between the lower and upper quartiles and describes the spread of the central half of the observations. Neither summary alone indicates the uncertainty in an estimated change or whether a change is statistically distinguishable from variation.
The endpoint description refers to a count of teeth meeting an inflammation threshold, and the record specifies median and inter-quartile range summaries. A distribution of counts may be uneven or concentrated near particular values. In general, choosing summaries and tests suited to the data distribution is important; however, the registry record does not explain the rationale for the chosen summaries or identify a model for the endpoint.
What does the self-controlled design compare?
In general, a self-controlled longitudinal design compares measurements from the same participants across time. Pairing measurements can account for some stable differences between participants, because each participant contributes observations at more than one visit. It does not control for factors that change over time, and it does not supply a concurrent untreated comparison. The study is listed as single-group, non-blinded, and self-controlled; no randomized allocation or masking is described.
The primary endpoint’s two stated assessment times are baseline and 12 weeks. The registry does not report whether the analysis used individual paired changes, compared visit-level summaries, or applied another method. It also does not report how participants without measurements at both times were handled. These distinctions affect the interpretation of an estimated change and its uncertainty.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the data under a specified statistical method and its assumptions. Its width reflects precision: narrower intervals indicate more precision, while wider intervals indicate less. A p-value, when used, describes how unusual the data would be under a specified null hypothesis and assumptions. Neither quantity states the probability that a treatment works. The registry record does not report a confidence interval or p-value for the primary endpoint.
The record names medians and inter-quartile ranges, but does not state whether an inferential method was used or how uncertainty around a change was calculated. It also does not report the analysis population, missing-data method, or assessment of model assumptions. As a result, the statistical strength and precision of the primary comparison cannot be evaluated from the reported record.
What do planning calculations represent?
In general, a sample-size planning illustration estimates the number of participants that might be needed under assumptions about the effect to detect, the significance level, allocation, and statistical method. The planning illustration associated with this record is described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such an illustration is not evidence that the trial used those assumptions in its design, and it is not observed power.
The illustration’s hypothetical two-arm allocation does not change the actual study design, which is listed as single-group with allocation NA. A planning calculation based on a fraction of an observed effect is conditional on that effect and the stated assumptions. The protocol’s own sample-size justification is not reported in the registry record. No planning sample-size output or observed effect estimate is stated in the record details, so no numerical planning result can be interpreted.
In general, over-dispersion occurs when observed variation exceeds what a statistical model assumes. If a count outcome is analyzed with a model that underestimates variation, standard errors can be too small and confidence intervals too narrow. This is a general consideration for count data; the registry record does not identify a count model or report an assessment of over-dispersion for this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and three analyses. It does not identify which analyses correspond to which outcomes, whether all were prespecified, or whether any adjustment for multiple statistical comparisons was planned or applied. When several outcomes or tests are examined, the chance of at least one apparently notable result can increase. In general, multiplicity procedures can address that issue, but the registry record does not report a procedure or enough detail to determine how multiplicity was handled.
The primary endpoint is identified as MGI change, but the primary analysis method and any hierarchy of secondary outcomes are not described. Adverse events are listed as a secondary outcome. The record does not say how the other outcome measures were prioritized or whether the three analyses were exploratory or confirmatory.
Missing-data handling and analysis populations are also not reported in the registry record. The enrollment figure does not establish the number with a baseline measurement, a 12-week measurement, or complete paired observations. The record does not state whether missing values were excluded, imputed, or handled using another method, nor does it describe exclusions after enrollment or protocol deviations.
These omissions limit assessment of both the primary estimate and the reliability of any secondary findings. Without the analysis population, missing-data approach, and multiplicity plan, readers cannot determine whether the reported analyses, if any, followed prespecified procedures or how incomplete data and multiple testing affected interpretation.
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 |
|---|---|---|---|
| Treatment Group | 0 | 60 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Group | 0 of 60 |
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 |
|---|---|
| Treatment Group | 0 of 60 |
The registry reports 0 serious adverse events among 60 participants at risk in the treatment group. It also reports 0 other adverse events among 60 at risk, and 0 deaths. No serious adverse-event terms are listed. These are the counts in the registry record; they do not supply details about event definitions, surveillance procedures, duration of safety follow-up, or whether every participant completed follow-up.
A zero count means that no events in that category were recorded in the registry results for the stated group. In general, a zero observed count does not establish that the underlying risk is zero. The interpretation depends on the amount and completeness of observation and how events were collected. Those details are not reported in the registry record.
The adverse-event figures are descriptive. They do not compare the regimen with a control group, because the study is single-group and no separate control arm is described. The registry does not provide event-level narratives or additional safety analyses. The reported counts should therefore be understood as the safety information recorded for this study, rather than a broader estimate of risk.
12. What the Result Does, and Does Not, Mean
The registry record describes a 90-day, non-blinded, single-group study in participants with gingivitis or Stage I or II periodontitis. Participants used the toothpaste and rinse twice daily, and the primary endpoint was MGI at baseline and 12 weeks. This establishes what the study set out to measure and the broad structure of the comparison.
It does not establish what the primary endpoint showed. Baseline and follow-up values, the estimated change, and statistical uncertainty are not reported in the registry record. The record therefore does not support a conclusion about the direction or size of the MGI change, or whether any change was distinguishable from chance variation under a particular analysis.
Even if a before-and-after change were available, a single-group comparison would describe change over time among participants using the regimen, not a randomized treatment effect relative to a control. General influences that vary over time could also contribute to observed differences. The design does not provide a concurrent group to separate those influences from changes associated with the regimen.
The zero adverse-event counts are likewise limited to the events recorded for this study. They do not show that adverse events are impossible, and the registry record does not provide enough detail to judge the completeness of event collection or follow-up.
In short, the registry conveys the study question, intervention, assessment schedule, and design limitations, but not the primary efficacy results needed to quantify the endpoint change. The results should not be interpreted as demonstrating benefit or lack of benefit from the regimen.
13. Why This Trial Matters Statistically
This trial is statistically notable because its design focuses on repeated observations within one group rather than a randomized comparison. That structure makes the distinction between describing change and estimating a comparative treatment effect especially important. A baseline-to-follow-up difference can be informative about the course of measured values, but it does not alone identify why those values changed.
The endpoint also illustrates why a clear measurement definition matters. The registry describes visual assessments, a rating scale, a threshold for identifying affected teeth, and a total count evaluated at each visit. It identifies medians and inter-quartile ranges as summaries. Those details help readers understand what the endpoint is intended to represent, even though the numerical results and inferential methods are not reported in the registry record.
The record also highlights the difference between enrollment and analysis. An enrollment of 60 does not reveal how many participants contributed complete observations or how missing measurements were handled. Without those details, neither the effective analysis population nor the possible influence of incomplete follow-up can be assessed.
Finally, the record includes descriptive adverse-event counts but does not provide broader safety analyses. Statistical interpretation depends not only on counts, but also on how events were defined and collected. Taken together, the design and reporting details show why estimates, uncertainty, analysis populations, and prespecified methods are central to interpreting clinical results.
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 most direct limitation for interpretation is that the registry record does not report the primary MGI results. The endpoint is defined and its assessment times are stated, but the baseline and 12-week summaries, change estimate, and uncertainty are absent. Statistical significance and the practical size of any observed change therefore cannot be assessed.
The study is listed as single-group, non-blinded, and self-controlled, with no separate comparator. Changes across visits cannot by themselves distinguish the regimen’s contribution from other time-varying influences. The record does not describe whether outcome assessors were independent or whether any procedures were used to reduce measurement bias.
The registry lists an enrollment of 60 but does not report the number analyzed for MGI, the completeness of follow-up, or the handling of missing observations. The analysis population and reasons for missing data are not reported in the registry record. This leaves uncertainty about how closely the measured participants represent everyone enrolled.
The statistical test or model, confidence-interval method, multiplicity approach, and analysis plan are not reported in the registry record. Nor does the record describe a protocol-based sample-size justification or interim analyses. These omissions prevent a detailed assessment of whether the analysis was prespecified, how uncertainty was quantified, and how multiple outcomes were handled.
Finally, the adverse-event record gives counts but not detailed collection methods, follow-up completeness, or event descriptions. These limits apply to interpretation of the registry record and do not establish that unreported procedures or results did not exist.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP — NCT05258721.
- Registry record last updated 2025-08-15; status last verified 2025-07.
- Results first posted 2023-03-15.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05258721 is listed as a completed Phase 2, single-group, non-blinded study sponsored by Rowpar Pharmaceuticals, Inc. The registry lists an enrollment of 60 and describes a 90-day self-controlled study in participants with gingivitis or Stage I or II periodontitis.
Participants used ClōSYS® Sensitive Fluoride Toothpaste twice daily and ClōSYS® Sensitive Rinse twice daily after brushing. The primary endpoint is MGI change between baseline and 12 weeks, summarized using the median and inter-quartile range. The registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the treatment group.
Primary endpoint values, inferential results, analysis populations, missing-data handling, and a detailed statistical analysis plan are not reported in the registry record. The single-group design does not include a separate control comparison.