Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH (NCT04249336), a randomized phase 3 study. The primary outcome is Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus.

2. Clinical Question

The trial asks whether pain responses among people with dentin hypersensitivity change after use of commercially available dentifrices, and whether the response differs across the assigned products over immediate and sustained assessments. The primary outcome is a percent change in the mean Schiff cold air sensitivity score from baseline following an air-blast stimulus. The registry record lists assessments at one minute, five minutes, day three, and week four.

This is a question about recorded responses on a clinical sensitivity scale, not a direct measure of every aspect of daily discomfort or oral health. The registry description specifies the scale and stimulus, but does not report the numerical outcome estimates needed to judge the size or precision of the observed changes. It also does not report whether any product had a larger mean change than another in the posted results available for this analysis.

3. Trial Design

The registry describes a randomized, triple-blinded, parallel-group clinical trial with four treatment groups. Its phase is listed as Phase 3, its status as completed, and the recorded enrollment as 140. The sponsor is Dow University of Health Sciences. The registry dates are a start of 2019-09-27 and a primary completion of 2021-01-16.

The four named groups used BioMin F, Colgate Sensitive Pro-Relief, Sensodyne Rapid Action, or Colgate Total. The registry describes the first three products by their respective dentifrice formulations and lists sodium fluoride for Colgate Total. Participants in each group were instructed to brush with a full strip of dentifrice on a dry toothbrush for one minute twice daily. Although the brief summary describes comparison with placebo, the intervention and arm descriptions identify Colgate Total as the fourth assigned dentifrice.

Randomized allocation means assignment was intended to be based on chance rather than solely on participant or clinician choice. The record labels masking as triple, but does not report which roles were masked or how masking was maintained. The parallel model means the assigned groups are compared rather than each participant being described as receiving each product in sequence. Details of the randomization procedure, allocation concealment, recruitment sites, and protocol deviations are not reported in the registry record.

The primary outcome is a percent change in mean Schiff cold air sensitivity scores after an air-blast stimulus. The outcome description gives assessment intervals from baseline to one minute, five minutes, day three, and week four. Additional listed outcomes concern percent change in mean pain response on a visual analog scale after mechanical and water-jet stimuli. The registry status indicates that the study is completed; it does not by itself establish that every randomized participant completed every assessment.

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: Of 380 assessed participants of self reported sensitivity in teeth, 140 met inclusion criteria and were randomized to treatment.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. After lost to follow up, statistical analysis was performed for 32 participants per group with baseline SCHIFF scale score of ≥2.

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: 35 individuals per treatment group were recruited and enrolled in the study after clinical diagnosis of dentin hypersensitivity using air blast stimulus and SCHIFF cold air sensitivity scale. These participants were tested again for dentin hypersensitivity using mechanical stimulus and Visual Analogue Scale. After lost to follow up, statistical analysis was performed for 32 participants per group with baseline SCHIFF scale score of ≥2 and visual Analogue Scale score of ≥4.

6. Primary Endpoint

The registry lists the primary outcome as Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus, measured over (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4).

The primary endpoint is the percent change in mean pain-response score from baseline on the Schiff cold air sensitivity scale, using an air-blast stimulus. The scale records an ordered response: no pain response, a pain response without a request to stop the stimulus, a pain response with a request to stop, or an immediate response requesting discontinuation. The registry describes the clinician assessing the response.

The record gives the percent-change calculation as the follow-up score minus the baseline score, divided by the baseline score. Its wording specifies an assessment from baseline to one minute and also lists baseline comparisons at five minutes, day three, and week four. The outcome is therefore intended to express change relative to each measure's starting value rather than simply report a follow-up score.

Using a standardized stimulus and response scale can make assessments more consistent across participants and visits. The endpoint also connects directly to the condition being studied: dentin hypersensitivity elicited by cold air. As a general statistical consideration, a change score can be difficult to interpret if baseline values vary substantially or if the scale's ordered categories are treated as if the distances between them were equal. The registry identifies a mean and standard deviation but does not report whether the analysis accounted for the ordinal character of the scale or how baseline values were handled beyond the stated percent-change formula.

Numerical estimates, variability, and confidence intervals for the primary endpoint are not reported in the registry record. Thus, the endpoint definition is available, but the size and precision of any observed change cannot be assessed in the registry record recorded for this analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the trial as randomized, triple-blinded, and parallel group. These design labels describe broad features, not the full statistical methods. The record does not report the sequence-generation method, allocation concealment, the roles kept unaware of assignment, or the analysis plan. Those details matter because they help readers evaluate whether treatment assignment was protected from foreknowledge and whether outcome assessment could have been influenced by knowledge of assignment.

What does randomization contribute?

As a general concept, randomization aims to distribute both measured and unmeasured participant characteristics across assigned groups by chance. It supports a comparison of outcomes between groups, provided the analysis respects the randomized assignment and missing observations or departures from assignment are handled appropriately. Randomization does not guarantee exact balance in every characteristic, especially in a trial of limited size. The record does not provide baseline characteristics or a description of the allocation procedure, so balance and allocation safeguards cannot be evaluated.

What does the mean and standard deviation describe?

The primary outcome is identified as a mean of a continuous measure, with standard deviation as the dispersion measure. The mean describes the average recorded value, while the standard deviation describes how spread out individual observations are around that average. A group mean alone does not reveal whether participants had similar responses or widely varying responses. The standard deviation is not the same as the uncertainty around the estimated mean or the uncertainty around a treatment contrast. Confidence intervals for estimates are not reported in the registry record.

The underlying Schiff scale is defined using ordered response categories. The record nevertheless specifies analysis of mean scores and percent change in mean scores. As a general methodological point, calculating means from an ordered scale treats the step between adjacent categories as comparable. That convention can be useful, but its interpretation depends on whether the numerical coding and summary adequately represent the responses. The registry does not report sensitivity analyses or alternative models for the ordinal outcome.

How should change from baseline be understood?

The registry describes percent change as follow-up score minus baseline score, divided by baseline score. A change score compares measurements within a participant and can express the follow-up value relative to the starting value. Its interpretation depends on baseline values; if a baseline score is zero, the stated division would not be defined. The record does not report how such values, if any, were treated, nor does it clarify whether the calculation was performed for each participant before taking a group mean or applied to group summary scores. This distinction can affect the resulting estimate.

As a general statistical approach, randomized trials often compare groups using a model that accounts for baseline outcome values and the repeated assessment structure. Such models can estimate treatment differences while using information across visits, but the registry record does not state whether this or another approach was used. It does not report the contrast definition, covariate adjustment, repeated-measures structure, or assumptions used for the primary analysis. No statistical method should be inferred solely from the endpoint description.

Why can repeated measurements and dispersion matter?

Measurements from the same participant at different visits are generally related rather than independent. General methods for repeated measurements account for that dependence; treating every observation as unrelated can misstate uncertainty. The registry lists multiple times but does not describe the model for those repeated measures. It also reports standard deviation as the outcome's dispersion measure, but the numerical dispersion values are not present in the available record details.

Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. In that case, standard errors may be too small if the model does not accommodate the extra variation, making confidence intervals too narrow and tests too optimistic. Whether over-dispersion applies to this trial cannot be determined from the registry description. The primary outcome is summarized as a mean with standard deviation, and no model diagnostics or discussion of over-dispersion are reported in the registry record.

What can sample-size illustrations tell readers?

A sample-size calculation is a planning exercise, not an observed result. The registry's stated illustration assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set as a fraction of the observed effect. These are described as planning illustrations based on an observed effect, not as the trial's own design justification. The registry does not report the trial's original sample-size rationale or a prospective target effect in the information available for this analysis.

Participants per arm for 80% power and other planning scenarios, when presented, would indicate the size of a hypothetical future study under specified assumptions. They would not show the probability that the completed trial detected an effect, and should not be called observed power. The registry notes that time-to-event illustrations use total events, whereas other illustrations use participants per arm. Since the primary outcome is continuous, any sample-size interpretation should follow the stated convention for non-time-to-event outcomes and should not be confused with the enrolled population.

The registry entries do not report an inferential model, p-values, confidence intervals, handling of missing outcomes, or an analysis population. These omissions limit assessment of the statistical evidence even though the design and endpoint are described. The registry record's statistical description should therefore be read as a partial account rather than a complete analysis plan.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is described at several follow-up times, and the study includes additional pain-response outcomes based on mechanical and water-jet stimuli. Four treatment groups also create several possible pairwise comparisons. When many outcomes, time points, and contrasts are examined, the chance of at least one apparently noteworthy result can increase. As a general statistical principle, investigators may define a primary contrast, adjust for multiple comparisons, or state that analyses are exploratory. The registry record does not report a multiplicity procedure, a hierarchy among the listed time points, or which treatment contrasts were prespecified.

Although the record labels an outcome primary, its description includes baseline comparisons at one minute, five minutes, day three, and week four. It does not identify one of these as the sole primary time point. The brief summary also frames the study around immediate and sustained relief. Without a prespecified strategy, it is difficult to determine how any collection of time-specific results should be interpreted as a whole. Numerical results by time point are not reported in the registry record.

Missing-data handling is also not reported in the registry record. The description of 35 individuals recruited and enrolled in each treatment group does not establish how many contributed data at every visit or whether any assessments were missed. The completed status does not resolve participant follow-up or analysis inclusion. No reasons for missing measurements, imputation method, sensitivity analysis, or treatment of withdrawals are described.

The analysis population is not reported in the registry record. It is therefore unknown whether the efficacy analysis included all randomized participants, only those who followed assigned treatment, or another defined set. This distinction matters because excluding participants after randomization can undermine the comparability that random assignment is intended to support. The record also does not describe protocol deviations or how they were addressed. These gaps prevent a full assessment of multiplicity control, attrition, and the population represented by any potential treatment-effect estimate.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists separate serious adverse-event, other adverse-event, and death counts for each of the four dentifrice groups. For each group, the recorded number at risk is 35 for both serious and other adverse events; the recorded number affected is zero for serious events and zero for other events, and deaths are recorded as zero. These are registry counts, not estimates of comparative risk.

A zero count means no event was entered in that category for the group in the registry record. It does not establish that an event was impossible, that all participants were observed for the same duration, or that every event was captured and classified. The registry does not report event definitions beyond the serious versus other categories, follow-up duration for safety, ascertainment procedures, or confidence intervals for event rates.

Rare events can be difficult to characterize in a trial of this scale, and a lack of recorded events does not by itself demonstrate equivalent safety across treatments. As a general principle, safety interpretation should consider the event definitions, observation period, completeness of follow-up, and uncertainty around counts, in addition to the raw numbers. Those details are not reported in the registry record. The counts should therefore be described narrowly as the events recorded in the listed categories, without treating them as proof of absence of harm or as a basis for medical advice.

12. What the Result Does, and Does Not, Mean

The record establishes that a randomized, triple-blinded, parallel-group trial compared four dentifrices for dentin hypersensitivity. It defines a primary clinical outcome using an air-blast stimulus and the Schiff cold air sensitivity scale and identifies several assessment times. It also describes other pain-response outcomes using mechanical and water-jet stimuli. These details make the research question and measurement approach understandable.

The record does not report the numerical primary outcome results or between-group estimates. It therefore cannot show from the information how much the mean response changed, whether changes differed between products, or how precise any comparison was. No conclusion about comparative efficacy follows from the design description alone. A randomized design can support causal comparisons when analyzed appropriately, but it is not itself evidence that a particular treatment produced a larger or clinically important change.

Likewise, the recorded zero adverse-event counts should be interpreted as reported counts within the registry categories, not a guarantee that no adverse effects occurred. The information available does not describe follow-up completeness, event ascertainment, or uncertainty around the counts. The completed status confirms the registry's status label, but it does not establish complete outcome data for every participant.

General statistical interpretation also distinguishes statistical evidence from clinical importance. A small estimated difference can be precisely measured yet have limited practical relevance, while a potentially meaningful difference can remain uncertain if estimates are imprecise. The registry entries do not include a threshold for clinically important change or estimates and intervals with which to make such a judgment. Consequently, readers can assess the design and the intended measurement, but not the size, precision, or clinical relevance of the treatment comparisons from the reported details.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it brings together a randomized comparison of four dentifrices, a clinician-assessed response to a standardized stimulus, and repeated assessments spanning immediate and later responses. That structure raises questions that recur across clinical research: how to distinguish within-group change from a treatment difference, how to handle correlated measurements over time, and how to interpret a mean derived from an ordered response scale.

The endpoint description makes clear that a treatment comparison should be tied to a defined scale, stimulus, and time point. Immediate response and later response are not interchangeable estimands. If several time points and product contrasts are examined, a transparent analysis plan is important to keep the interpretation focused and to account for multiplicity. Such a plan is not reported in the registry record.

The registry also offers a useful distinction between trial design and statistical evidence. Random allocation and masking describe safeguards intended to reduce bias, while estimates and their uncertainty are needed to understand what the observed data indicate. The design labels alone cannot establish whether the groups differed. Here, the record gives an endpoint definition and safety counts, but the numerical efficacy estimates are not reported in the registry record.

Finally, the stated sample-size illustrations are planning tools based on the observed effect under specified assumptions, rather than evidence about the completed trial's probability of detecting an effect. Keeping planning assumptions separate from observed results is important when translating a trial into future research. In this case, the registry's design and measurement details raise substantive methodological questions, while the missing inferential results limit answers about the comparative outcome.

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.

Several trial-specific limitations of interpretation follow from the registry record. The primary outcome is defined as percent change in mean Schiff scores, but the record does not clarify whether participant-level percentage changes were averaged or whether group summaries were used to calculate the change. It also does not report how baseline scores of zero, if present, were handled under a formula that divides by the baseline score. These details affect interpretation and reproducibility.

The outcome scale consists of ordered response categories, yet the endpoint is summarized as a mean. The registry does not report whether the analysis treated the scale as continuous, used an ordinal model, or assessed the robustness of the findings to alternative approaches. Nor does it describe assessor training or agreement, despite the clinician assessing response to the air blast.

The timing language names several baseline-to-follow-up intervals, including one minute, five minutes, day three, and week four. The record does not specify a single primary time point or provide the statistical hierarchy for these assessments. It also does not describe how repeated observations within participants were modeled. This leaves uncertainty about how the intended evidence across time was organized.

Important conduct and analysis details are absent: the randomization procedure, allocation concealment, masking roles, participant flow, missing-data methods, analysis population, protocol deviations, and adjusted or unadjusted contrast definitions are not reported in the registry record. The registry also does not provide numerical efficacy estimates, confidence intervals, or tests for the primary outcome. The safety entries lack details on event definitions, ascertainment, and duration. These limitations are specific to the record's available descriptions and do not establish that the underlying study lacked such procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH — NCT04249336.
• Registry record last updated 2021-05-11; status last verified 2021-04.
• Results first posted 2021-05-11.
• 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.

18. Record Summary

The registry record describes a completed Phase 3 randomized, triple-blinded, parallel-group trial sponsored by Dow University of Health Sciences. Enrollment is listed as 140, with a start date of 2019-09-27 and primary completion date of 2021-01-16. The study concerns dentin hypersensitivity and assigns participants to BioMin F, Colgate Sensitive Pro-Relief, Sensodyne Rapid Action, or Colgate Total dentifrice.

The primary outcome is percent change from baseline in mean Schiff cold air sensitivity score after an air-blast stimulus. The listed assessment intervals are one minute, five minutes, day three, and week four. Other outcomes concern visual analog scale pain responses to mechanical and water-jet stimuli. Instructions describe brushing for one minute twice daily.

Serious adverse events, other adverse events, and deaths are recorded as zero in each group. Numerical primary efficacy estimates, uncertainty intervals, missing-data methods, and the analysis population are not reported in the registry record. The available information therefore supports a description of the design and outcome definitions, but not a quantitative conclusion about comparative treatment effects.