NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study (NCT01669785), a randomized na study. The primary outcome is Baseline Pre-Prophy Assessment (Tactile Sensitivity).

2. Clinical Question

The clinical contrast of interest is between the two NovaMin-containing pastes and the classic paste, with Group A and Group B also differing in fluoride content. The registry record does not describe a direct statistical comparison between Groups A and B. The posted comparisons use Group A as the reference for Group B and Group C.

The study enrolled 139 participants. The record describes two sensitive teeth per subject for assessment and says the score was averaged across the evaluated teeth. Because the primary measurement is made before treatment, a difference between randomized groups on that outcome would describe a baseline contrast, not an effect of the assigned paste. Whether and how the study assessed subsequent tactile sensitivity is not reported as a posted primary result in the registry record.

3. Trial Design

The study is recorded as randomized, triple-masked, and parallel-group, with 139 participants enrolled. Its status is completed. The listed study start is 2012-03 and the primary completion is 2012-04. The record does not identify which people were masked or describe the allocation procedure beyond stating that allocation was randomized.

There were three groups. Group A received NUPRO Sensodyne Prophy Paste with 15% NovaMin and no fluoride. Group B received NUPRO Sensodyne Prophy Paste with 15% NovaMin and 1.23% fluoride ion. Group C received NUPRO Classic Prophy Paste without NovaMin or fluoride. The listed interventions are classified as devices. All three pastes were administered on day one only, using a single-procedure unit dose, left in contact for 60 seconds, rinsed with water, and expectorated.

The registry’s primary outcome was a tactile sensitivity assessment before treatment. An electronic force-sensing Yeaple probe applied force in steps from 10 to 50 grams until pain was elicited. The score was the average across the evaluated teeth. The record states that higher scores, corresponding to more force needed to elicit a pain response, indicate lower hypersensitivity.

The study summary describes an objective of assessing immediate and extended sensitivity relief up to 28 days. Several self-assessment outcomes are listed, including pre-treatment, post-scaling, post-prophylaxis, and long-term sensitivity relief. However, the original statistical analysis plan, trial-specific sample-size justification, exact masking roles, and details of follow-up procedures are not reported in the registry record. The registry outcome listings also do not establish that all stated follow-up assessments have posted results.

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

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 Baseline Pre-Prophy Assessment (Tactile Sensitivity), measured over Pre-treatment measurement.

The primary outcome is titled Baseline Pre-Prophy Assessment (Tactile Sensitivity). It is a continuous measure, recorded in grams, of the force required to elicit pain from a hypersensitive tooth before prophylaxis. The electronic force-sensing Yeaple probe applied force in steps of 10, 20, 30, 40, and up to 50 grams until pain was elicited. The subject’s score was the average across the evaluated teeth.

The endpoint is clinically interpretable as a measure of tactile sensitivity at baseline: the registry description says that needing more force to elicit pain corresponds to lower hypersensitivity. Such a baseline measure can describe the groups before treatment and help readers understand the observed starting scores.

Its timing is crucial. Because it is recorded before the assigned paste is used, this outcome cannot show whether any paste changed sensitivity or provided relief. The registry record’s stated objective includes immediate relief and relief up to 28 days, but the listed primary outcome is not a post-treatment change score or a follow-up measurement. A post-treatment primary result, a baseline-adjusted treatment comparison, or a change-from-baseline analysis is not reported in the registry record.

The posted group means are 10.56 for Group A, 10.0 for Group B, and 10.98 for Group C. The standard deviations are 1.59, 0.0, and 2.27, respectively. These values describe the baseline outcome in the posted groups; they should not be interpreted as treatment responses.

7. Results Posted in the Registry

• Group B: mean 10.00 versus 10.56 on control; difference -0.56 (95% CI -1.02 to -0.10), standardized effect d = -0.51; z-test p = 0.018.
• Group C: mean 10.98 versus 10.56 on control; difference 0.42 (95% CI -0.38 to 1.22), standardized effect d = 0.21; z-test p = 0.306.

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.

Sensitivity Relief (Self-Assessment)

• 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:
  • Group B: mean 0.67 versus 0.82 on control; difference -0.15 (95% CI -0.45 to 0.15), standardized effect d = -0.20; z-test p = 0.325.
  • Group C: mean 0.76 versus 0.82 on control; difference -0.06 (95% CI -0.36 to 0.24), standardized effect d = -0.08; z-test p = 0.695.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group B and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group C and the control. The interval gives the range of effects that remain compatible with the data.

Post- Scaling Sensitivity Relief (Self-Assessment)

• 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:
  • Group B: mean 0.98 versus 1.31 on control; difference -0.33 (95% CI -0.63 to -0.03), standardized effect d = -0.45; z-test p = 0.030.
  • Group C: mean 1.28 versus 1.31 on control; difference -0.03 (95% CI -0.34 to 0.28), standardized effect d = -0.04; z-test p = 0.850.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Group B than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group C and the control. The interval gives the range of effects that remain compatible with the data.

Post-prophylaxis Sensitivity Relief (Self-Assessment)

• 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:
  • Group B: mean 0.90 versus 1.00 on control; difference -0.10 (95% CI -0.45 to 0.25), standardized effect d = -0.12; z-test p = 0.574.
  • Group C: mean 1.09 versus 1.00 on control; difference 0.09 (95% CI -0.24 to 0.42), standardized effect d = 0.11; z-test p = 0.593.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group B and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Group C and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover self-assessed sensitivity before treatment, immediately after scaling, and immediately following prophylaxis. Across these measures, the estimated contrasts do not show one consistent pattern across both comparisons with Group A. The unadjusted comparisons include results with p-values above and below conventional thresholds, but these should be read as exploratory because the registry does not report an adjustment for testing multiple outcomes and contrasts.

The secondary measures differ from the primary endpoint in measurement approach: they are self-assessments rather than the electronic-probe tactile score. They also differ in timing. The pre-treatment self-assessment is a baseline description; the post-scaling and post-prophylaxis measures are recorded after procedures. Their scale is given as units on a scale, but further details about score direction, interpretation, or a threshold for meaningful change are not reported in the registry record.

These results do not resolve the mismatch between the stated study objective and the posted primary outcome. The primary tactile assessment is pre-treatment, while the study summary describes immediate and extended relief. The secondary results offer additional observations at immediate timepoints, but a full prespecified analysis connecting baseline and follow-up scores is not reported in the registry record. A result for long-term sensitivity relief is also not reported in the registry record.

Unadjusted secondary findings carry less weight than a clearly specified primary analysis because several endpoints and comparisons create more opportunities for chance patterns. The record lists four secondary outcome titles, but reported analyses are not listed for them. The displayed recalculations are not a substitute for a complete analysis plan, missing-data account, or multiplicity strategy. The appropriate overall reading is therefore descriptive: the secondary measures add context, but they do not establish a coherent or confirmatory treatment conclusion.

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

• Sensitivity Relief (Self-Assessment)
• Post- Scaling Sensitivity Relief (Self-Assessment)
• Post-prophylaxis Sensitivity Relief (Self-Assessment)
• Long-term Sensitivity Relief (Self-Assessment)

9. Statistical Interpretation

10. Statistical Methods Explained

For continuous outcomes, a mean is the arithmetic average of the recorded scores in a group. The standard deviation describes how spread out those scores are around the group mean. These summaries are useful for understanding the recorded outcomes, but they do not by themselves establish whether groups differ because of treatment. In this study, the primary measure is explicitly pre-treatment, so its means and standard deviations describe starting scores.

What does a mean difference represent?

The posted recalculations compare each group with Group A. A mean difference is calculated as the other group’s mean minus Group A’s mean. A negative value means the compared group’s mean is lower on the measured scale; a positive value means it is higher. For the primary baseline outcome, the Group B versus Group A difference is -0.56 grams, while the Group C versus Group A difference is 0.42 grams. Because these measurements precede treatment, neither contrast represents a change caused by paste.

The recalculated comparisons use the posted group summaries rather than a reported trial analysis. They are unadjusted comparisons of means. The registry does not report the sponsor’s analysis method, a model adjusted for baseline characteristics, or the analysis populations used. The posted recalculations should therefore be distinguished from an analysis specified and reported by the study investigators.

How should a confidence interval be understood?

A confidence interval gives a range of values compatible with the observed data and the method’s assumptions. It conveys uncertainty around an estimated mean difference. An interval that includes zero is compatible with no difference as well as with differences in either direction at the interval’s stated confidence level. An interval that excludes zero indicates that the estimate is less compatible with zero under that calculation, but it does not establish clinical importance or remove limitations in the outcome timing, analysis, or reporting.

In general, confidence intervals tend to be wider when estimates are less precise and narrower when the data provide more precision. Precision depends on features such as the amount of variability and the number of observations. Here, the group sizes range from 45 to 48 for the posted primary outcome. The Group B standard deviation is reported as 0.0, which differs from the nonzero standard deviations in the other groups. The registry record does not explain that value, so readers should not assume it reflects a particular data-processing or measurement reason.

What does an unadjusted p-value tell the reader?

The p-values accompanying the recalculated comparisons are unadjusted. In general, a p-value evaluates how unusual data at least as different as those observed would be under a null hypothesis and a statistical model. It is not the probability that the null hypothesis is true, and it is not the probability that a treatment works. The primary comparison of Group B with Group A has p = 0.018; the comparison of Group C with Group A has p = 0.306. Since the outcome is baseline, neither value is a test of post-treatment relief.

The record lists multiple secondary outcomes, while no multiplicity adjustment is reported. When multiple comparisons are examined, the chance of observing a small p-value by chance across the set can increase. The p-values should be interpreted in the context of that family of outcomes and comparisons, rather than as isolated confirmatory findings.

Why does outcome timing matter?

A randomized design aims to create comparable groups on average, but randomization does not turn a pre-treatment outcome into a treatment response. Baseline differences can occur by chance. To assess change after treatment, a study would need a relevant post-treatment measure or a comparison of change from baseline, analyzed according to an appropriate plan. The registry record does not report a primary post-treatment analysis or the details of such a plan.

The study summary describes immediate and extended relief up to 28 days, and the outcome list includes self-assessment measures at different times. However, the timeframes posted for the available self-assessment results include pre-treatment, immediately post-scaling, and immediately following post-prophylaxis. A long-term result is not reported in the registry record. The presence of an outcome title alone does not supply a result or establish the analysis used.

What do standardized effects add?

In general, a standardized mean difference expresses a group contrast relative to a measure of variability, allowing comparisons across outcomes measured on different scales. It does not convert the score into a clinical threshold, and its interpretation depends on the underlying measure and context. Although standardized estimates are included in the recalculated statistics, they do not resolve the key issue that the primary measure is a baseline score. Nor do they replace the study’s own analysis, which is not reported in the registry record.

These statistical concepts help separate the observed summaries from stronger claims. The means describe group scores, mean differences describe contrasts, confidence intervals characterize uncertainty, and p-values describe compatibility with a null model. None can establish a treatment effect when the outcome being compared was recorded before treatment.

11. Confidence Intervals and Precision

The confidence intervals around the recalculated mean differences express uncertainty about the estimated contrasts. For the primary baseline comparison of Group B with Group A, the interval lies below zero; for Group C compared with Group A, it includes zero. The corresponding unadjusted p-values are 0.018 and 0.306. These interval and p-value patterns describe the baseline comparisons only, not sensitivity relief after prophylaxis.

A confidence interval should not be read as a range in which the true value is guaranteed to fall. In general, it is a range generated by a statistical procedure that has a stated long-run coverage property when its assumptions hold. Its width reflects precision under that method. A broad interval leaves more uncertainty about the size and direction of a contrast, while a narrower interval is more precise, though precision alone does not determine clinical relevance.

The posted primary group sizes are 45, 48, and 46. The Group B standard deviation is 0.0, while Group A and Group C have standard deviations of 1.59 and 2.27. The record does not explain the zero spread. Because the uncertainty calculation depends on the observed variation as well as group sizes, this feature is important context for interpreting Group B’s estimate and interval. The recalculation is not a substitute for clarification from the registry or an investigator analysis.

For the secondary self-assessments, intervals around the unadjusted mean differences likewise represent uncertainty in those comparisons. Some include zero and one does not. Those comparisons involve multiple outcomes and are not reported as adjusted analyses. In general, selecting results from a collection of unadjusted comparisons can make isolated interval or p-value patterns less persuasive than a prespecified, multiplicity-aware analysis.

The central precision limitation is not merely interval width: it is that the primary endpoint is a baseline measurement. A precise baseline contrast remains a baseline contrast. Post-treatment precision for the intended relief question cannot be established from the posted primary results, and the long-term outcome result is not reported in the registry record.

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 assumptions. They state participants per arm for comparisons of two groups. They are not total event counts. The planning assumptions 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 at the stated fraction of the observed effect.

The 80% power column gives the modeled number of participants per arm for an 80% chance of detecting the specified effect under those assumptions, if that effect and model were correct. The 90% power column gives the corresponding per-arm count for a 90% chance. These are design-planning quantities, not probabilities that the observed result is true, and not estimates of the study’s achieved power.

For example, planning for 100% of the observed primary baseline effect in the Group B versus Group A comparison gives 62 participants per arm for 80% power and 82 participants per arm for 90% power. Planning for 75% of that observed effect gives 109 participants per arm for 80% power and 146 participants per arm for 90% power. The figures increase when the target effect is smaller: a smaller difference is harder to distinguish from variability, so more participants are required under the same assumptions.

These calculations use effects estimated from this study’s posted summaries. The primary measure is baseline, so the observed contrast used for the illustration is not an estimate of treatment relief. The trial’s original sample-size justification and its own design assumptions are not reported in the registry record. These figures are planning illustrations only, not observed power.

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 = -0.560; pooled standard deviation σ = 1.106.
2. n = 2 × (1.96 + 0.842)² × 1.106² / -0.560² = 61.2, rounded up to 62 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 <- -0.56                      # observed difference in means
sigma <- 1.10561205763053                     # 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(1669785)
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 = 62 (80% power), 82 (90% power)
 75% of observed effect: n per arm = 109 (80% power), 146 (90% power)
 50% of observed effect: n per arm = 245 (80% power), 328 (90% power)
power.t.test: 62.2 
Simulated power at n = 62 per arm: 0.804 (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. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and several secondary outcomes, including different self-assessment timepoints. The posted recalculated comparisons include Group B versus Group A and Group C versus Group A. With several outcomes and comparisons, multiplicity is relevant: in general, conducting many tests can increase the chance of at least one apparently unusual result even when there is no underlying difference. The registry record does not report a multiplicity adjustment, a hierarchy of testing, or a prespecified strategy for interpreting the full set of outcomes.

The registry’s reported analyses are not reported in the registry record. That means the statistical analysis plan, any model choices, adjustment variables, handling of repeated measurements, and criteria for the primary comparison are not available in the record. The unadjusted recalculations should not be presented as the trial investigators’ own confirmatory analysis.

The number of participants contributing to each outcome is shown for the posted summaries, but the record does not provide a detailed missing-data account or explain whether all randomized participants were included in each analysis. The reason for any difference between enrollment and outcome sample sizes is not reported in the registry record. The analysis population, such as intention-to-treat or per-protocol, is not reported in the registry record.

The record also does not explain the Group B standard deviation of 0.0 for the primary outcome. That prevents a fully informed assessment of the observed spread and the basis for the recalculated uncertainty. The method used to manage missing measurements, protocol deviations, or data outside the scale limits is not reported in the registry record.

These omissions do not demonstrate that the investigators failed to conduct analyses or manage missing data. They mean that the methods and decisions cannot be assessed from the registry record. A clear account of prespecified outcomes, analysis populations, multiplicity, and missing-data handling would be needed to interpret the results as a complete confirmatory analysis.

15. 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 0% reporting threshold.

The serious adverse event figures report zero affected participants in Group A, zero in Group B, and zero in Group C, among 45, 48, and 46 participants at risk, respectively. The record also reports zero participants affected by other adverse events in each of those groups. These figures describe what is posted for the listed groups during the recorded safety assessment.

A zero count means no event in that category was reported for the participants represented in the registry fields; it does not establish that an event is impossible or that no event occurred outside the recorded definitions or observation period. The adverse-event observation period and event-collection procedures are not reported in the registry record. Death counts are not reported in the registry record.

These safety figures should be interpreted in light of the study size and available reporting detail. They do not provide a complete safety profile, and they do not support comparisons beyond the counts recorded. The registry record does not list serious adverse event terms for these groups.

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

The record documents a randomized, triple-masked, parallel-group comparison of three prophylaxis pastes in participants with tooth hypersensitivity. It includes group-level summaries for a tactile sensitivity score and several self-assessment measures. Those summaries are useful for describing what was posted, but their meaning depends on the endpoint timing and the reporting details.

The primary outcome is a pre-treatment score. Its group means and the recalculated contrasts describe baseline values before the assigned paste was administered. A baseline difference, whether or not its unadjusted p-value is small, is not evidence that one paste relieved sensitivity. The randomized design is relevant to treatment comparisons, but the measurement’s timing still determines what can be concluded from it.

The registry summary states an intention to assess immediate relief and extended relief up to 28 days. Some post-procedure self-assessment values are posted, but a complete sponsor analysis of the relief objective is not reported in the registry record. A long-term result is not reported in the registry record. Thus the available results do not support a complete evaluation of the stated time horizon or a firm conclusion about comparative relief.

The posted recalculations are unadjusted, and no registry-reported analyses are listed. The underlying statistical plan, multiplicity approach, analysis population, and missing-data handling are not reported in the registry record. These limits matter when interpreting isolated p-values and intervals, especially across several outcomes.

In general, a statistically detectable difference is not automatically clinically important, and a result that is not statistically detectable does not prove that groups are equivalent. Clinical thresholds and the direction or meaningful size of changes on the self-assessment scale are not reported in the registry record. The data should therefore be described as reported, without turning them into medical advice or a claim that a paste does or does not work.

17. Why This Trial Matters Statistically

This study is a useful example of why endpoint timing must be checked before interpreting a statistical contrast. The primary endpoint is titled and described as a baseline, pre-prophylaxis assessment. A group difference in that measure cannot answer a question about relief after the assigned intervention, even when the study itself is described as intending to investigate immediate and extended relief.

It also illustrates the distinction between a trial’s own analysis and a recalculation from summary statistics. Recalculated means, confidence intervals, and unadjusted p-values can help readers understand the posted data, but they cannot recover unreported choices about the model, analysis population, missing observations, or multiplicity. Those choices are important to judging whether a result was prespecified and how it should be interpreted.

The zero standard deviation reported for Group B’s primary outcome is another statistical detail that deserves attention. It is a property of the posted summary, but its explanation is not available in the registry record. Readers should recognize its relevance to the estimated uncertainty without guessing at its cause.

Finally, planning calculations based on an observed effect are not the same as the trial’s original sample-size justification. They show how modeled sample requirements change when the target effect is smaller, under stated assumptions. Because the effect is derived from a baseline contrast in this case, such calculations should not be mistaken for a design recommendation for assessing treatment relief.

18. 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 specific limitation is that the registry’s primary outcome is measured before treatment, even though the study summary describes an objective of assessing immediate and extended relief. Baseline summaries cannot establish changes following treatment. The record does not post a primary post-treatment result or an analysis of change over time.

The posted comparisons are unadjusted recalculations from summary statistics. They are not listed as reported sponsor analyses. The trial’s original statistical plan, sample-size justification, analysis population, covariate adjustment, handling of repeated measures, and missing-data methods are not reported in the registry record.

The record lists several secondary self-assessment outcomes, but no reported analyses are listed for them. The scale’s direction and clinically meaningful threshold are not reported in the registry record. A long-term result is not reported in the registry record, despite the study summary’s reference to relief up to 28 days. The available timeframes include pre-treatment and immediate post-procedure assessments.

The Group B standard deviation for the primary score is reported as 0.0. The registry record does not explain why, limiting assessment of the recorded variability and the recalculated comparison. The masking roles, allocation details beyond randomization, and full eligibility criteria are also not reported in the registry record.

The safety record reports zero affected participants for serious and other adverse events in each group, but the observation period and collection procedures are not reported in the registry record. Death counts are not reported in the registry record. These limits constrain interpretation of both efficacy-related outcomes and safety reporting.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study — NCT01669785.
• Registry record last updated 2014-08-21; status last verified 2014-08.
• Results first posted 2014-08-21.
• 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.

22. Record Summary

NCT01669785 is a completed, randomized, triple-masked, parallel-group study sponsored by Dentsply International. It enrolled 139 participants with tooth hypersensitivity and compared two NovaMin-containing prophylaxis pastes with a classic paste. The listed study start is 2012-03, and primary completion is 2012-04.

The primary registry outcome is a pre-treatment tactile sensitivity score measured in grams with an electronic force-sensing probe. The record posts group means and standard deviations and selected self-assessment summaries. The primary outcome timing means its contrasts describe baseline scores, not treatment effects.

Unadjusted recalculations are available for comparisons with Group A, while the trial’s own reported analyses, original sample-size justification, multiplicity approach, and missing-data methods are not reported in the registry record. A long-term sensitivity-relief result is not reported in the registry record. The safety fields list zero affected participants for serious and other adverse events in each group; death counts are not reported in the registry record.