Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity (NCT01592851), a randomized phase 3 study. The primary outcome is Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14.

2. Clinical Question

3. Trial Design

The registry identifies this as a Phase 3, randomized, single-masked, parallel-group clinical study. Its stated purpose was to compare a test dentifrice with a control dentifrice for reducing dentinal hypersensitivity over a two week treatment period. The study is marked completed. The record lists an enrollment of 113 and reports the trial start as 2012-04 and primary completion as 2012-05.

The two interventions were a dentifrice containing stannous fluoride and a marketed dentifrice containing sodium monofluorophosphate. The reported primary outcome analysis includes 56 participants in the SnF Dentifrice group and 57 in the NaMFP Dentifrice group. These are the group counts for the reported endpoint, not a claim about the number of participants included in every other analysis.

The primary outcome was measured from baseline to Day 14. The registry also lists assessments of air sensitivity immediately after treatment administration and at Day 3, as well as tactile pain-threshold assessments at several time points. Those outcomes provide additional measures of sensitivity, but the Day 14 air-sensitivity change is the designated primary endpoint.

The registry reports an ANCOVA analysis for the primary comparison, giving an adjusted mean difference, confidence interval, and p-value. The trial’s detailed masking procedures, allocation implementation, original sample-size justification, and full statistical analysis plan are not reported in the registry record. The meaning and limitations of the available outcome summaries therefore depend on the information that the record does report.

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 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.

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.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14, measured over Baseline to Day 14.

The primary endpoint is the change from baseline to Day 14 in response to an evaporative air stimulus, measured on the Schiff Sensitivity pain response scale. The registry describes a constant jet of air directed at sensitive teeth. Each stimulated tooth receives a response score from 0 to 3: 0 indicates no response, while higher scores describe increasing response and requests to stop the stimulus. A score of 3 represents a response in which the participant considers the stimulus painful and requests discontinuation.

The registry states that teeth meeting the tactile-threshold inclusion criterion were assessed at baseline and Day 14. The investigator applied air to the facial surface of the two sensitive teeth selected at baseline, and the subject-level score was calculated as the mean change across those teeth. A change score captures movement from each participant’s own baseline rather than only the score observed at Day 14.

This outcome is used to quantify a stimulus-evoked response in a form that can be summarized across participants and compared between randomized groups. The scale is ordinal in its individual response categories, while the registry reports the endpoint as a mean continuous measure. That summary provides a group-level description, but does not show the distribution of individual responses or how many participants had a particular score.

7. Results Posted in the Registry

• NaMFP Dentifrice: mean -0.37 versus -1.20 on control; difference 0.83 (95% CI 0.62 to 1.04), standardized effect d = 1.43; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NaMFP Dentifrice: mean -0.14 versus -0.40 on control; difference 0.26 (95% CI 0.11 to 0.41), standardized effect d = 0.64; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for NaMFP Dentifrice than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NaMFP Dentifrice: mean -0.25 versus -0.70 on control; difference 0.45 (95% CI 0.26 to 0.64), standardized effect d = 0.89; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for NaMFP Dentifrice than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in Tactile Pain Threshold Score at Day 14

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • NaMFP Dentifrice: mean 3.50 versus 22.90 on control; difference -19.40 (95% CI -25.13 to -13.67), standardized effect d = -1.26; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for NaMFP Dentifrice than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists five secondary outcomes, covering air-evoked sensitivity at immediately post-treatment and Day 3, and tactile pain-threshold change at the listed assessment times. For the secondary outcomes with posted numerical results, the group summaries and reported analyses generally point in the same broad direction as the primary result: the SnF Dentifrice group has a larger average change in the direction represented as reduced air sensitivity or increased tactile threshold, depending on the measure. These outcomes broaden the description of the study beyond the Day 14 air-sensitivity endpoint, but they do not replace the primary result.

Each secondary measure captures a different aspect or timing of sensitivity. Air response scores and tactile threshold scores use different scales and cannot be interpreted as interchangeable units. The pattern across them can be considered supportive context, but a collection of favorable secondary comparisons does not independently establish the strength of the primary result or show that every participant experienced a similar response.

Unadjusted secondary p-values carry less weight when several outcomes and time points are examined. With multiple comparisons, the chance of at least one apparently strong result arising by chance can increase unless the analysis plan accounts for multiplicity. The registry does not report a multiplicity adjustment or a prespecified hierarchy for the secondary outcomes. This means the secondary findings are best read as exploratory or contextual evidence, rather than as a set of equally definitive confirmatory tests.

The registry also does not provide a common threshold for clinical importance across these measures. Their statistical comparisons can describe average group differences, but the available record does not establish how those differences correspond to a meaningful experience for an individual. The overall pattern is consistent with the primary direction, while uncertainty about multiplicity and clinical interpretation remains.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment
• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3
• Change From Baseline in Tactile Pain Threshold Score at Day 14
• Change From Baseline in Tactile Pain Threshold Score at Day 3
• Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment

9. Statistical Interpretation

10. Statistical Methods Explained

What does the reported ANCOVA estimate?

ANCOVA is a method for comparing groups on a continuous outcome while accounting for one or more covariates. In a baseline-adjusted clinical comparison, it commonly estimates a group contrast after taking baseline outcome values into account. The registry names ANCOVA and reports an adjusted mean difference, but does not report the complete model specification or all covariates used. Those details are not reported in the registry record, so the adjustment cannot be independently reconstructed from the available summary.

An adjusted mean difference is a contrast between model-based group means, not the same quantity as simply subtracting the two posted group changes. The posted group means allow an unadjusted comparison of the changes. The sponsor’s adjusted estimate is the registry’s own inferential analysis and takes precedence over that simple recalculation. Because the group order differs between the two reported contrasts, one is positive and the other negative even though both point in the same direction when interpreted according to their stated group order.

What does the unadjusted recalculation add?

A simple unadjusted comparison uses the reported mean changes and their variability to describe the difference between groups without covariate adjustment. It is useful as a transparent check on the scale and direction of the observed group summaries. It does not reproduce the sponsor’s ANCOVA, and it does not account for any covariates that may have entered that model. Agreement in direction can be reassuring about interpretation, but it does not make the two analyses identical.

The standard deviations describe spread of participant-level change scores within each group. They are distinct from standard errors, which describe uncertainty in estimated means. Greater variability among individual changes generally makes a group mean less precise when the group size is unchanged. The registry’s posted summaries do not provide participant-level data, so they cannot show the shape of each group’s distribution or reveal whether a small number of observations strongly influenced the mean.

How should the p-values be read?

A p-value measures how incompatible the observed data are with a specified null hypothesis under the assumptions of the analysis. For the reported adjusted analysis, the null is a zero adjusted mean difference. A small p-value is evidence against that null within the stated model; it is not the probability that the null is true, and it does not quantify the probability that the result arose by chance in a general sense. It also does not measure the size or clinical importance of the difference.

The registry reports p < 0.001 for the adjusted primary comparison, while the unadjusted recalculation reports p < 0.001. These are threshold statements, not exact p-values. The difference in thresholds reflects the way each result is reported and should not be treated as a substantive disagreement between analyses. The registry does not report whether the primary p-value was adjusted for multiple comparisons.

Why can over-dispersion matter?

Over-dispersion is a general concern when a statistical model assumes less variability than the data contain. If a model understates variability, its standard errors may be too small and its intervals too narrow, making evidence appear more precise than it is. It is especially relevant in models for counts or rates, where the variance can exceed the model’s expected variance. The primary endpoint is reported as a continuous mean and standard deviation, and the registry does not report an over-dispersion assessment. There is therefore no basis in this record to claim that over-dispersion was identified or corrected for this endpoint.

What can the reported summary not show?

The primary outcome description defines the analysis population as randomized participants who received at least one treatment and had at least one post-baseline efficacy assessment. This definition does not by itself explain how missing outcome values were handled, how many randomized participants lacked an assessment, or whether any other analysis populations were used. Those details are not reported in the registry record. The record also does not describe model diagnostics, assumptions checks, or sensitivity analyses. These gaps limit independent evaluation of robustness, even though the reported adjusted estimate and its uncertainty are available.

Overall, the methods support reading the result as a group-level adjusted comparison of mean change, alongside a simpler unadjusted check. Neither method provides individual-level predictions, and neither resolves questions that depend on missing-data handling, model details, or multiplicity procedures that the registry does not report.

11. Confidence Intervals and Precision

The sponsor-reported primary estimate is an adjusted mean difference of -0.83, with a 95% confidence interval from -1.03 to -0.63. The interval describes a range of values compatible with the observed data under the specified analysis and its assumptions. It communicates uncertainty about the estimated average contrast; it does not mean that 95% of individual responses fall within the interval, nor that the true difference has a 95% probability of lying there in a frequentist interpretation.

The interval is entirely below zero for the sponsor’s stated group ordering, which is consistent with the reported p < 0.001. The direction must be interpreted using that group order. The registry’s unadjusted recalculation uses the reverse contrast, NaMFP minus SnF, and consequently has a positive mean difference. These sign conventions describe the same directional pattern rather than opposite findings.

Precision is distinct from effect size and clinical importance. An interval can be relatively concentrated around an estimate while the importance of that difference remains a separate question. The registry does not report a threshold for a clinically important change on this scale, so the interval cannot by itself determine whether differences of the sizes it contains are meaningful to participants.

The confidence interval also depends on the analysis and the data available for it. The registry reports the adjusted interval but does not report the full ANCOVA specification or missing-data methods. The interval therefore gives useful precision information for the sponsor’s reported model, while the available record does not allow every modeling assumption to be checked independently.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial’s original design calculation. For these continuous outcomes, the figures are participants per arm. The registry’s general assumptions for the illustration are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the planned number of participants per arm that the illustration estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions, if the effect and assumptions were correct. The 90% power column gives the corresponding per-arm planning number for a higher chance of detection. These are planning targets, not guarantees: actual performance depends on the true effect, variability, analysis choices, and other features of a future study.

The table considers planning for the full observed effect and for smaller fractions of it. Smaller effects are harder to distinguish from random variation, so the illustration requires more participants per arm as the effect being targeted becomes smaller. This is not observed power. It does not describe the probability that this completed trial detected its result, and it should not be used as evidence about the reliability of the observed finding.

The figures are useful for understanding how assumptions about the effect size translate into approximate study scale. They should not be treated as a substitute for a protocol-specific design calculation, which would need prespecified assumptions and the intended analysis. The registry record does not state that these illustrative values were used to plan the trial.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.830; pooled standard deviation σ = 0.580.
2. n = 2 × (1.96 + 0.842)² × 0.580² / 0.830² = 7.7, rounded up to 8 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.83                      # observed difference in means
sigma <- 0.579720342644344                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1592851)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 8 (80% power), 11 (90% power)
 75% of observed effect: n per arm = 14 (80% power), 19 (90% power)
 50% of observed effect: n per arm = 31 (80% power), 42 (90% power)
power.t.test: 8.7 
Simulated power at n = 8 per arm: 0.760 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analysis as ANCOVA, with an adjusted mean difference of -0.83, a 95% confidence interval from -1.03 to -0.63, and p < 0.001. The posted recalculation from the group summary statistics is an unadjusted mean difference of 0.83 for NaMFP minus SnF, with p < 0.001. The two estimates use opposite group ordering, so their signs differ. Read in each stated order, both indicate a larger reduction in the SnF group’s average score.

The unadjusted calculation is a check based on the posted group means and spread; it is not a reconstruction of ANCOVA. The adjusted analysis may account for baseline or other covariates, but the full model details are not reported in the registry record. The registry does not flag a discrepancy between the recalculation and sponsor analysis. Accordingly, the sponsor’s own adjusted analysis is the principal inferential result, while the recalculation provides a simpler descriptive comparison of the posted summaries.

The displayed p-values should also be read in their reported form: both are threshold values rather than exact values. Differences in those thresholds do not change the basic interpretation of the primary comparison.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study assesses more than one outcome, time point, or comparison. If each is tested separately without adjustment, the chance of obtaining at least one small p-value under a collection of null effects can be greater than for a single prespecified test. The registry lists a primary endpoint alongside secondary outcomes at several time points. It does not report whether multiplicity was handled using an adjustment, a hierarchy of testing, or another prespecified approach. The primary result should therefore be distinguished from the collection of secondary comparisons, whose unadjusted results carry less confirmatory weight.

The primary outcome population is described as randomized participants who received at least one study treatment and provided at least one post-baseline efficacy assessment. This definition clarifies who could contribute to that analysis, but it does not explain how missing outcome values were treated. The registry does not report the number of participants with missing primary assessments, the reasons for missingness, any imputation method, or sensitivity analyses for missing data. It is not possible from the record to evaluate whether missingness could have influenced the estimated comparison.

The record reports an ANCOVA analysis but does not give the complete model specification, its assumptions checks, or a detailed statistical analysis plan. It also does not report whether interim analyses were conducted or whether any stopping rules were used. These points are not reported in the registry record and should not be inferred from the p-value or the completed status.

These omissions do not erase the reported result, but they narrow what can be independently assessed. The adjusted estimate and interval are available for interpretation; the full procedures that would support a detailed audit of multiplicity, missing data, and model robustness are not.

16. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

The registry’s adverse-event summary reports zero serious adverse events in the SnF Dentifrice group among 56 participants at risk, and zero in the NaMFP Dentifrice group among 57 participants at risk. These figures describe the serious adverse-event counts recorded in the registry for the stated groups. They do not establish that no adverse events of any kind occurred, and they should not be interpreted as a complete safety profile.

The record also lists zero other adverse events affecting participants in each group. Death counts are not reported in the registry record, so no conclusion about deaths should be drawn from the blank entries. The registry provides no serious adverse-event terms because none are listed. A zero count in a trial summary does not prove that an event is impossible or that a treatment is free of risk; it means that the record reports no events in these categories for this study.

Safety interpretation is limited by the group sizes, the study’s duration, and the completeness of adverse-event reporting. The registry record does not give additional detail about event collection procedures or follow-up beyond the study information described. These figures should therefore be read as the trial’s posted event summary, not as a stand-alone assessment of safety in other settings or populations.

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

The primary result describes an average change in air-evoked sensitivity scores over the stated assessment period and a between-group comparison of those changes. The group means and sponsor-reported adjusted estimate favor a larger reduction in the SnF group’s average score relative to the NaMFP group, with a confidence interval that does not include zero. This is a statistical description of the trial’s posted outcome, not a guarantee that an individual participant experienced the average change.

The result does not establish how many participants improved, stayed the same, or worsened, because those distributions are not reported in the primary summary. It also does not show whether the mean difference meets a threshold that participants would consider important. Such a threshold is not reported in the registry record. Statistical evidence against a zero average difference and evidence of practical importance are related but separate questions.

The finding is specific to the described dentifrices, outcome scale, trial population, and Day 14 assessment. The registry record does not establish that the result applies to other formulations, populations, durations, or measures of sensitivity. The secondary results provide additional context, but multiplicity procedures are not reported, so they should not be treated as a set of independent confirmations.

The reported zero serious adverse-event counts are also limited to the trial’s posted summary and cannot establish absence of risk. Likewise, limitations in the reported missing-data and analysis details mean that the full robustness of the estimates cannot be independently assessed from the registry record. The result is best understood as a reported group-level comparison with quantifiable statistical uncertainty, alongside limits on broader or individual-level conclusions.

18. Why This Trial Matters Statistically

This trial illustrates several core issues in interpreting clinical statistics. First, the direction of a mean difference depends on the order in which groups are subtracted. Here, the unadjusted recalculation is expressed as NaMFP minus SnF, while the sponsor’s adjusted estimate is presented in the opposite direction. Their signs differ, but the group-level pattern is consistent once the contrast order is made explicit.

Second, an adjusted estimate and a simple comparison of posted means answer closely related but not identical questions. ANCOVA can account for covariates, while a recalculation from group summaries does not. The registry’s adjusted estimate is therefore the principal inferential result, and the unadjusted calculation is useful as a transparent descriptive check rather than a replacement analysis.

Third, confidence intervals and p-values provide different but complementary information. The interval communicates uncertainty about the estimated mean contrast, while the p-value describes compatibility with a zero-difference null under the analysis assumptions. Neither statistic alone establishes clinical importance or describes individual responses.

Finally, the secondary outcomes and sample-size illustrations show why study interpretation needs more than a list of statistically significant findings. Multiple outcomes raise multiplicity questions, and planning values derived from observed effects are not the same as original design assumptions or evidence of observed power. Distinguishing reported analysis, recalculation, planning illustration, and missing registry entries helps keep conclusions proportional to the evidence.

19. 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 registry gives a concise summary rather than a full statistical report. It names ANCOVA but does not report the complete model specification, covariates, diagnostics, or sensitivity analyses. This limits independent evaluation of the adjusted estimate and the assumptions on which its interval and p-value depend.

The primary analysis population requires at least one post-baseline efficacy assessment, but missing-data counts, reasons, and handling procedures are not reported in the registry record. The record also does not report whether multiplicity was controlled across secondary outcomes and assessment times. This matters when interpreting the secondary findings as confirmatory evidence.

The outcome is a mean change on a response scale described by ordered categories at the tooth level. The registry reports a continuous mean summary, but does not provide participant-level distributions or a clinically important threshold. Consequently, the record supports a comparison of group averages, not a conclusion about the proportion of participants with meaningful improvement.

The trial’s original sample-size justification and its design assumptions are not reported. The planning illustrations based on observed effects cannot fill that gap. Further, the posted serious adverse-event counts are limited summaries, and the record does not provide extensive information about event collection or longer-term follow-up. These trial-specific gaps constrain judgments about robustness, clinical meaning, and how broadly the findings can be applied.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity — NCT01592851.
• Registry record last updated 2014-06-03; status last verified 2014-02.
• Results first posted 2014-06-03.
• 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.

23. Record Summary

The registry describes a completed Phase 3 randomized, single-masked, parallel-group study comparing a stannous fluoride dentifrice with a marketed sodium monofluorophosphate dentifrice for dentinal hypersensitivity. The primary endpoint was change from baseline to Day 14 in air-evoked response on the Schiff Sensitivity scale.

The posted group summaries show a larger mean reduction in score for the SnF Dentifrice group. The sponsor-reported ANCOVA gives an adjusted mean difference of -0.83, with a 95% confidence interval from -1.03 to -0.63 and p < 0.001; the sign reflects the sponsor’s group ordering. The recalculation uses the reverse contrast and is consistent in direction.

Secondary outcomes provide further context, while multiplicity procedures, detailed missing-data methods, and the original sample-size justification are not reported in the registry record. Serious adverse-event counts are reported as zero in both groups.