Adhese One F Upgrade in Direct Filling Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adhese One F Upgrade in Direct Filling Therapy (NCT02175368), a na na study. The primary outcome is Number of Participants With Clinical Success.

2. Clinical Question

The clinical question is descriptive rather than comparative. The registry’s stated hypothesis is that the new adhesive shows acceptable clinical performance and allows good filling quality. However, the primary endpoint focuses on a specific short-term success definition, not on every aspect of filling quality or adhesive performance. The registry lists clinical quality as a secondary outcome, but the results for that outcome are not reported in the registry record.

Because the study has one group, the question that can be addressed from its design is whether success was observed among participants treated with the adhesive under the study conditions. Without a comparator, the design cannot directly estimate how outcomes would differ under another adhesive, protocol, or no treatment. The primary endpoint result itself is not reported in the registry record, so the reported study information does not establish how many participants met the success definition.

3. Trial Design

The registry identifies this as a completed, single-group device study of Adhese One F Upgrade in direct filling therapy. Enrollment was 28. The intervention description specifies use after phosphoric acid etching, following an etch-and-rinse protocol. The study began in 2012-06, and primary completion is listed as 2015-06. These dates describe the registry timeline; they do not establish how long each participant was followed beyond the endpoint timeframe specified for the primary outcome.

Allocation is recorded as NA, masking as none, and the model as single group. Thus the registry does not describe random allocation or a masking procedure, and it does not identify a concurrent control group. The intervention is the only arm described. This structure is suited to reporting outcomes observed in the treated group, but it does not provide a like-for-like treatment comparison. The registry itself flags the lack of a randomized comparison and notes that arms are not a like-for-like control comparison.

The primary outcome is the number of participants with clinical success, measured at one week. Success is defined as having no postoperative hypersensitivity and no loss of the restoration. Clinical quality is listed as a secondary outcome. Although the registry states that there are two outcome measures, it does not report their numerical results in the registry record. It also records zero analyses. The specific analysis methods, analysis population, and treatment of missing observations are not reported in the registry record.

The registry lists the study status as completed. That status means the study is recorded as completed, but it does not substitute for a report of endpoint findings. The posted information therefore supports describing the design and planned outcome definition, but not estimating clinical success from the primary endpoint. In particular, enrollment of 28 should not be mistaken for the number who completed follow-up or the number who met the endpoint; those counts are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

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 Number of Participants With Clinical Success, measured over 1 week.

The primary endpoint is the number of participants with clinical success at one week. The registry defines success as the absence of postoperative hypersensitivity and the absence of restoration loss. The measure is a count of participants meeting that combined definition, rather than a measurement of the severity of symptoms or a time-to-event outcome.

A binary success definition can make a clinical outcome easier to interpret: each participant either meets the stated criteria or does not. A count can then describe how many participants reached the defined outcome in the study group. This approach is useful when a study aims to assess a specific clinical status at a stated assessment time. Its meaning depends on the exact definition: both absence of hypersensitivity and retention of the restoration are required for a participant to count as a success.

That simplification also leaves out detail. The endpoint does not, by itself, describe the intensity or duration of hypersensitivity, the nature of any restoration loss, or other aspects of clinical quality. Those matters would require other measures or additional reported detail. Clinical quality is listed as a secondary outcome, but its findings are not reported in the registry record.

The one-week timeframe makes the endpoint a short-term assessment. It should not be interpreted as a measure of longer-term restoration performance. Most importantly, the registry record does not report the number meeting the definition, the number assessed, or an uncertainty estimate for the primary endpoint. The endpoint is therefore defined, but its observed result cannot be interpreted from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a count of participants with an event, where the event is meeting the clinical-success definition. That definition is binary at the participant level: success requires both no postoperative hypersensitivity and no loss of the restoration. The endpoint is assessed at one week. The record does not report a statistical analysis of this outcome, so the explanation below describes general statistical concepts rather than methods confirmed to have been used in this study.

What does a count of participants describe?

General statistical explanation: a count is the number of people who meet a prespecified outcome definition. For a binary outcome, each person is classified according to whether the criteria are met. A count is directly interpretable, but by itself it does not show how complete the assessment was. Interpreting a count usually requires knowing the number assessed and the number with missing outcome information. Those details are not reported in the registry record for the primary endpoint.

A count can also be expressed as a proportion when the relevant denominator is known. No proportion is reported for this endpoint, and deriving one would require outcome information not recorded. The enrollment figure of 28 is not necessarily the endpoint denominator: enrollment and assessment at the specified follow-up are different quantities. The number assessed at one week is not reported in the registry record.

Why does the single-group design matter?

General statistical explanation: a single-group study can describe outcomes observed among participants receiving an intervention, but it cannot directly estimate a difference between that intervention and a concurrent comparator. A comparison requires outcome information for each group and a design or analysis that supports interpreting the contrast. This study is recorded as single group, with allocation NA and no comparator arm described. It therefore does not provide a randomized treatment contrast. The registry also explicitly notes that this is not a randomized comparison and that arms are not a like-for-like control comparison.

Masking is recorded as none. General statistical explanation: masking can reduce the influence of knowledge about treatment assignment on some aspects of care, assessment, or reporting. The registry does not describe a masking procedure. The record does not provide details that would clarify who knew the intervention or how outcome assessment was conducted, so those specifics are not reported in the registry record.

What would an uncertainty estimate add?

General statistical explanation: a confidence interval gives a range of values compatible with the observed data under a statistical model and its assumptions. It helps distinguish an estimate that is relatively precise from one that remains uncertain. A count without a denominator or uncertainty estimate cannot, on its own, show the precision of an outcome estimate. No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record.

A hypothesis test, when used, addresses a specified statistical question under assumptions about the data and analysis. A p-value is not a measure of clinical importance and does not reveal the probability that a hypothesis is true. The registry records zero analyses and does not report a p-value, test, or statistical model for the primary endpoint. No inferential result can therefore be attributed to the registry record.

What does the planning illustration mean?

General statistical explanation: sample-size planning illustrations explore how many participants might be needed under stated assumptions about a target effect, significance level, allocation, and statistical model. They are design calculations, not observations from the trial. The registry’s planning description states a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it also describes the target effect as a stated fraction of the observed effect. These are assumptions for a planning illustration, not evidence that the actual study used a two-arm design. The actual study is recorded as single group.

A planning calculation based on an observed effect is especially dependent on the effect estimate used. The registry does not report the primary endpoint result, so that result cannot be evaluated from the registry information. Any sample-size illustration should be read as planning context, not as an observed study finding or as observed power. No sample-size justification for the trial’s own design is reported in the registry record.

General statistical explanation: over-dispersion is relevant when observed variability exceeds what a chosen statistical model expects. In that setting, a model that assumes less variability than the data contain can make uncertainty appear too small. The primary endpoint is described as a binary participant count, and the registry does not report a model or analysis for which over-dispersion could be assessed. It would therefore be inappropriate to claim that over-dispersion was present or that a method addressing it was used.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Adhese One F Upgrade")
n      <- c(28)
events <- c(28)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Adhese One F Upgrade  28  28  100.0  87.7  100.0  87.9  100.0  88.1  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies clinical quality as a secondary outcome, alongside the primary clinical-success endpoint. It does not report the numerical results for either measure in the registry record. The analysis count is recorded as zero. The statistical plan, including whether multiple outcomes were tested or how any multiplicity was handled, is not reported in the registry record.

General statistical explanation: when several outcomes or statistical tests are considered, the chance of a false-positive finding can increase if each is interpreted without accounting for the set of analyses. Common approaches define a primary outcome in advance, adjust inference for multiple comparisons, or treat secondary findings as exploratory. The registry identifies a primary outcome, but it does not provide enough information to determine what multiplicity procedures, if any, were planned or used.

The primary outcome is specified for one week, but the registry does not report how missing endpoint data were handled. The number assessed, the number with missing data, and the reason for any missing observations are not reported in the registry record. General statistical explanation: missing outcomes can affect interpretation when the likelihood of missingness is related to participants’ outcomes or characteristics. A complete-case analysis, an imputation method, and sensitivity analyses make different assumptions; none can be attributed to this study from the registry information.

The analysis population is also not reported in the registry record. It is unclear from the recorded information whether an analysis was intended to include all enrolled participants, only those receiving the intervention, or only those with an available one-week assessment. These details matter because the denominator determines what a participant count means. No analysis population or missing-data strategy should be inferred from enrollment alone.

12. 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’s adverse-event fields for Adhese One F Upgrade report 0 serious adverse events among 28 participants at risk, 0 other adverse events among 28 participants at risk, and 0 deaths. These are the recorded counts for the intervention group. The registry lists no top serious adverse-event terms.

These figures are descriptive. They state what was recorded in the registry fields; they do not demonstrate that risk is absent, establish a comparison with another intervention, or show that every participant had complete safety follow-up. The registry record does not provide additional detail about event definitions, ascertainment procedures, follow-up completeness, or the timing of safety assessments.

General statistical explanation: when an event is uncommon, observing no events in a study does not establish that the underlying event risk is zero. The precision of a safety estimate depends on the number observed and the number at risk, as well as on how events were collected and over what period. Here, the registry reports the event counts and participants at risk, but does not report an uncertainty interval or a comparative safety analysis.

The primary endpoint is clinical success at one week, while the adverse-event fields are separate registry entries. The absence of recorded serious events should not be treated as a primary endpoint result. The registry does not report the number of participants meeting the clinical-success definition.

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

The registry record establishes the study’s basic purpose and design: an evaluation of Adhese One F Upgrade after phosphoric acid etching in direct filling therapy, with a single group and a primary clinical-success endpoint at one week. It defines success as no postoperative hypersensitivity and no loss of the restoration, and records enrollment of 28 participants. These details clarify what was intended to be evaluated, but they do not tell how participants actually fared on the primary outcome.

The registry does not report the primary endpoint count, an analysis, or an uncertainty estimate. As a result, the posted information cannot show the proportion meeting the endpoint, how precise an estimate would be, or whether the result was consistent across participants. The registry’s hypothesis about acceptable clinical performance and good filling quality remains a hypothesis in the absence of reported findings. Clinical quality is listed as a secondary outcome, but its result is also not reported in the registry record.

The single-group design is another important boundary. An observed outcome in such a study would describe the enrolled group under the study conditions, but would not by itself establish how outcomes compare with a different adhesive or protocol. There is no randomized comparator described in the registry. The study therefore cannot directly support a causal treatment contrast from the recorded design.

The adverse-event entries report 0 serious adverse events, 0 other adverse events, and 0 deaths among 28 at risk. Those counts are part of the record, but they do not show that risk is impossible or provide a comparative safety estimate. The registry does not describe further event ascertainment details or safety precision.

In sum, the record is informative about the intervention, endpoint definition, and study structure, but it does not report the clinical outcome result needed to evaluate the stated primary question. It does not establish long-term performance, comparative effectiveness, or a complete account of clinical quality. Those conclusions would require information not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically instructive because its stated clinical question and its design need to be kept distinct. The registry defines a clinically interpretable short-term endpoint, but records a single-group design without a comparator. That distinction matters: a clear outcome definition does not turn a descriptive study into a comparative one. Even with a reported outcome count, the design would not estimate a randomized contrast against another treatment.

The record also illustrates why enrollment is not an outcome. Enrollment is 28, but the primary endpoint result and the number assessed at one week are not reported in the registry record. Without those values, readers cannot calculate or interpret the observed success frequency, and cannot assess its precision. Treating the enrollment count as if it were a complete endpoint denominator would make an unsupported assumption.

Another statistical lesson is that a registered hypothesis is not evidence of a result. The stated hypothesis concerns acceptable clinical performance and good filling quality. The primary endpoint offers a defined way to assess one aspect of short-term clinical status, but the registry does not report its outcome count. The secondary clinical-quality result is also absent. Reporting the analysis and its uncertainty is essential for moving from an intended question to an interpretable finding.

The safety entries offer a further example of careful reading. Recorded zero counts are descriptive observations, not proof of zero underlying risk. Their interpretation depends on follow-up and event ascertainment, details not reported in the registry record. A lack of a comparator also means the record cannot estimate a relative safety difference.

Finally, the planning assumptions listed in the registry should not be confused with the actual study design or an observed result. Planning illustrations are hypothetical calculations under stated assumptions, whereas this study is recorded as single group. Keeping design, endpoint, observed findings, uncertainty, and planning calculations separate prevents conclusions from extending beyond what the record supports.

15. 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 main limitation for interpreting the primary question is that the registry record does not report the primary endpoint result. Although the endpoint is defined as a count of participants with clinical success at one week, the count and the number assessed are absent. The record therefore does not permit an estimate of the endpoint frequency or its precision.

The single-group design is a trial-specific limitation for comparative interpretation. Allocation is recorded as NA, masking as none, and no comparator arm is described. The study can be characterized as an evaluation of outcomes in the intervention group, but the registry design does not provide a randomized like-for-like comparison. The registry itself cautions that it is not a randomized comparison.

The registry lists 28 enrolled participants, but does not report how many completed the one-week assessment, whether any endpoint data were missing, or how missing observations were handled. It also does not report the analysis population. These omissions make it impossible to determine the endpoint denominator or assess potential effects of missing outcome information.

Clinical quality appears as a secondary outcome, but its result is not reported in the registry record. The record does not provide the statistical analysis plan, any analysis results, uncertainty estimates, or details about multiplicity. It also does not report further information about outcome assessment procedures or the clinical characteristics used to define the study population.

The adverse-event entries report zero serious events, zero other events, and zero deaths among 28 at risk, but the record does not give additional details about event collection, follow-up completeness, or safety analysis. These omissions limit the conclusions that can be drawn from the safety counts. Finally, the one-week primary endpoint is short-term; longer-term restoration performance is not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Adhese One F Upgrade in Direct Filling Therapy — NCT02175368.
• Registry record last updated 2025-04-01; status last verified 2025-03.
• Results first posted 2018-04-09.
• 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.

19. Record Summary

The registry records a completed, single-group device study of Adhese One F Upgrade in direct filling therapy. The intervention was used after phosphoric acid etching under an etch-and-rinse protocol. Enrollment was 28. The study start is listed as 2012-06, and primary completion as 2015-06.

The primary outcome is the number of participants with clinical success at one week, defined as no postoperative hypersensitivity and no loss of the restoration. Clinical quality is listed as a secondary outcome. Numerical results for the primary and secondary outcomes are not reported in the registry record, and the analysis count is zero.

The registry records 0 serious adverse events, 0 other adverse events, and 0 deaths among 28 at risk. The study has no comparator arm described, and the record does not provide an analysis population, missing-data approach, or statistical analysis results. The available information supports description of the design and endpoint, but not an estimate of clinical success or a comparative treatment effect.