Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative (NCT03032705), a randomized na study. The primary outcome is Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category.

2. Clinical Question

The registry description says that, for each participant, one cavity-bearing tooth was randomly selected for one material and a second cavity-bearing tooth was randomly selected for the other. That setup makes the comparison relevant to restorations placed in different teeth of the same participant. However, the registry also classifies the model as parallel. It does not explain how that classification relates to the description of both materials being used within each participant.

The study concerns esthetic, functional and biological properties in its brief summary, while the named primary endpoint is specifically esthetic. The primary measure is therefore not a single overall judgment of whether one material is preferable. It is a set of category-specific tooth counts based on an examiner’s ratings. Numerical results for those endpoint categories are not reported in the registry record, so the comparative primary question cannot be answered from the record alone.

3. Trial Design

The registry lists this as a randomized, single-masked study with a parallel model. It identifies SonicFill™ 2 and Filtek™ Supreme as the two device interventions. The brief summary describes a within-participant arrangement: each participant has one tooth assigned to each material. The combination of that description with the parallel-model classification is not explained in the registry record, so the exact analysis structure should not be inferred from the model label alone.

The registry reports enrollment of 51 and lists the study as completed. The recorded start date is 2017-06-19, and the primary completion date is 2020-02-05. The endpoint description says 45 participants had two teeth sampled, while also noting that dropouts and replaced restorations left fewer units in the end-of-study categories. It reports that 29 participants completed Visit 5, with 28 SonicFill™ 2 teeth and 27 Filtek™ Supreme teeth represented at that visit; one SonicFill™ 2 restoration had been replaced.

The planned observation period for the primary endpoint runs from baseline up to two years after placement. The record does not specify the masking target, such as whether the examiner, participant, or another study role was masked. It also does not report details of the randomization sequence, allocation concealment, site structure, eligibility criteria beyond the dental-caries condition, or how replacement restorations were handled in the primary analysis.

The brief summary says that the materials are intended for filling cavities and describes differences in how they are placed. Those procedural descriptions provide context for the comparison, but they do not establish that the study results favor either material. The registry record does not report the numerical primary outcome results needed to assess the observed esthetic ratings.

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:

Analysis population for the primary outcome, as defined in the registry: 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Each participants contributed 2 randomly selected teeth for each study group therefore 1 participant contributing 2 study teeth in each case. Therefore total number of participants is 45 and total number of units is 90.

6. Primary Endpoint

The registry lists the primary outcome as Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category, measured over From Baseline up to 2 Years After Restoration Placement.

The primary endpoint is the number of teeth rated in each of five esthetic categories: surface luster, surface staining, margin staining, color match and translucency, and esthetic anatomical form. Each category is graded on a five-point scale, with 1 described as excellent and 5 as clinically unacceptable. A blinded examiner is specified in the endpoint description. The assessment spans baseline up to two years after restoration placement.

These categories describe different visible features of a restoration rather than collapsing them into one overall score. Counting teeth at each rating can show how observations are distributed across the scale within each category. The measure is relevant to a comparison of restorative materials because the trial’s stated purpose includes examining esthetic properties, and the listed categories capture features that can be judged during clinical follow-up.

The endpoint is not a single continuous score, and the registry record does not specify a single summary contrast across categories. The posted endpoint title refers to the number of teeth rated at each level in each category. Numerical counts and comparative estimates for those categories are not reported in the registry record. It is therefore not possible to describe the observed direction, size, or precision of an esthetic difference from this record.

The endpoint description also indicates that fewer units were analyzed in end-of-study categories because of participant dropout and replaced restorations. The record does not give category-specific counts or explain how missing assessments and replacements were incorporated into the endpoint analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the rating scale represent?

The primary endpoint uses ordered ratings, with 1 representing excellent and 5 representing clinically unacceptable. An ordered scale tells the reader that ratings have a meaningful rank, but it does not guarantee that the distance between successive ratings is equal. For example, a change from one rating to the next need not represent the same amount of clinical change throughout the scale. General statistical methods for ordered outcomes can preserve that ranking rather than assuming the scale behaves like a measurement with equal intervals.

The endpoint is reported as counts of teeth in each rating category, separately for each esthetic feature. Such counts retain detail about the distribution of ratings. They are not interchangeable with a single average or a single overall score, neither of which is specified as the primary endpoint in the registry record. The record does not give the category-specific counts or an analysis that combines categories.

Why does the unit of analysis matter?

The endpoint is measured on teeth, while the trial description also identifies participants. The brief summary says each participant has a tooth assigned to each material. When two teeth from one participant contribute observations, their outcomes may be more alike than outcomes from unrelated participants because they share participant-level characteristics. In general, an analysis of such paired observations should reflect the relationship within each participant. Ignoring dependence can make uncertainty estimates too small or otherwise misrepresent the precision of a comparison.

That general point does not establish which method this trial used. The registry lists the model as parallel but describes assignments that place both materials within each participant. The statistical plan, the analysis unit, and the way within-participant association was handled are not reported in the registry record. The discrepancy should therefore be treated as an unresolved reporting detail, not as evidence that a particular method was used.

How should uncertainty be understood?

In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical method. A narrower interval indicates greater precision under that method; a wider interval indicates more uncertainty. An interval does not remove concerns about missing observations, inappropriate analysis structure, or bias in measurement. The registry record does not report a confidence interval for the primary endpoint, so the precision of any material comparison cannot be assessed from this record.

A p-value, when reported, addresses how compatible the data are with a specified null model under the assumptions of the analysis. It does not measure the size or clinical importance of an effect. The registry record does not report primary-endpoint p-values or an inferential analysis. No significance claim can therefore be made on the basis of the registered endpoint description alone.

What does the sample-size illustration mean?

General planning calculations are not observed trial results and are not a measure of the probability that a completed trial found a real effect. The planning illustration associated with this study is described as using the observed effect as its starting point, two-sided significance level 0.05, equal allocation, and a normal approximation. It considers detecting a stated fraction of that observed effect. These are planning assumptions, not evidence that the trial was designed with those assumptions or that its actual analysis followed them.

For time-to-event calculations, the stated convention is to report the total number of events using the Schoenfeld approach. For other calculations, the convention is participants per arm. Any such values should be read as hypothetical planning requirements under the stated assumptions, not as observed enrollment, observed power, or a post hoc assessment of the trial’s success. The registry record does not report its original sample-size justification or statistical plan.

Why can over-dispersion matter?

General count-data methods sometimes assume that variation follows a particular relationship to the mean. Over-dispersion means the observed variation is greater than the model expects. If it is not addressed, estimated uncertainty can be too small and statistical conclusions can appear more precise than warranted. This concept is relevant to some analyses of counts, but the primary endpoint consists of category-specific tooth counts and the record does not identify a model or report an over-dispersion assessment. It would be inappropriate to claim that over-dispersion was present or that any particular remedy was used.

More broadly, the available registry description does not establish how ratings were summarized, how repeated visits were modeled, or whether any covariate adjustment was planned. Those details are not reported in the registry record. General statistical explanations can clarify why such choices matter, but they cannot replace an account of the actual analysis.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint includes five esthetic categories, and each category uses a five-point rating scale. Looking at multiple categories and rating levels can create multiple opportunities for apparent differences. General statistical practice distinguishes between a prespecified primary comparison and exploratory or secondary comparisons, and may use a multiplicity strategy to control the chance of false-positive findings across a family of tests. The registry record does not report such a strategy or identify a single contrast across the categories.

The record lists three outcome measures, while the number of analyses recorded is zero. Numerical primary endpoint results and inferential comparisons are not reported in the registry record. The analysis population, any intention-to-treat or per-protocol definition, and any handling of repeated observations are also not reported.

Missing data are relevant because the endpoint description notes participant dropout and replaced restorations, says end-of-study categories had fewer units, and reports that 29 participants completed Visit 5. It also provides the tooth counts represented at that visit for the two materials. These details do not explain why individual observations were missing, whether replacement restorations were assessed as new units, or what assumptions were made about outcomes that were not observed. The registry record does not report imputation, sensitivity analyses, or another missing-data method.

In general, missingness can affect both the composition of the analyzed observations and the uncertainty of the estimated comparison. Without a stated analysis population and missing-data approach, the extent to which the final endpoint estimates represent all randomized assignments cannot be assessed.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record lists 51 participants at risk in each group and zero serious adverse events in each group. It also lists 45 at risk for other adverse events, with 14 recorded in the SonicFill™ 2 group and 15 in the Filtek™ Supreme group. Deaths are listed as zero in both groups. These are the event figures recorded for the study; the record does not provide additional serious-event terms.

These counts should be read as registry entries, not as a complete account of the nature, timing, duration, or severity of every event. The record does not clarify whether the other-event counts represent participants affected or events counted, nor does it explain the difference between the at-risk denominators shown for serious and other events. No rates or comparative safety estimates are reported, and none should be inferred from the counts alone.

Zero recorded serious events does not establish that serious events were impossible or that the two materials have identical safety. The trial record’s safety entries are descriptive and should be interpreted alongside the limited information about follow-up and event definitions. The registry record does not report detailed event narratives or a formal statistical comparison of adverse events.

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

The record describes a randomized comparison of two restorative materials and identifies an esthetic primary endpoint assessed over follow-up from baseline up to two years. It gives the rating categories and scale direction, and it reports attendance and tooth representation at Visit 5. These details establish what the study set out to measure and provide some context about the observations available later in follow-up.

The record does not report numerical results for the primary esthetic categories, a material contrast, confidence intervals, or p-values. Consequently, it does not establish whether the observed ratings differed, how large any difference was, or how precisely a difference was estimated. It also does not establish that the materials are equivalent, because equivalence requires a defined margin and an analysis designed to assess that question; neither is reported in the registry record.

Likewise, an absence of reported estimates cannot be interpreted as evidence of no effect. The registered endpoint is category-specific, and any practical interpretation would depend on the distribution of tooth ratings, the handling of repeated teeth and visits, and the amount and pattern of missing data. Those analysis details are not reported.

The safety entries show zero serious adverse events recorded for either group and other adverse-event counts as listed. They do not provide a basis for a definitive comparison of safety, and they do not answer the esthetic endpoint question. The strongest conclusion supported by the registry record is therefore descriptive: it documents the intended comparison and selected follow-up information, but does not report the outcome estimates needed to judge the comparative results.

13. Why This Trial Matters Statistically

This trial raises statistical issues that commonly arise when clinical outcomes are assessed on several units within the same participant. The brief summary describes two teeth per participant receiving different materials. In general, teeth within a participant may share characteristics, making their outcomes statistically dependent. Recognizing the participant-level pairing can affect the choice of analysis and the precision of a comparison. The registry’s parallel-model label does not clarify how that dependence was handled.

The endpoint also illustrates the distinction between an ordered clinical rating and a simple numerical measurement. The five-point scale has a clear ranking from excellent to clinically unacceptable, but equal spacing between its values is not established. Reporting tooth counts at each rating preserves information about the distribution. A single summary number could obscure that distribution, while many category-specific comparisons raise questions about multiplicity.

Attrition and replacement are also important. The registry notes that fewer units were represented in end-of-study categories, reports Visit 5 completion, and identifies a replaced restoration. Such changes in the available observations can affect interpretation and precision. Transparent reporting of missing-data handling and analysis populations would help readers assess how the registered estimand relates to the observed data.

Finally, the case demonstrates the difference between a registered question and a reported result. The record describes the intervention, comparator, endpoint and follow-up, but the numerical primary outcome findings and analysis methods are not reported. Statistical interpretation depends not only on a clearly named outcome, but also on estimates, uncertainty, and enough methodological detail to understand how those estimates were obtained.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most direct limitation is that numerical results for the primary esthetic endpoint are not reported in the registry record. There are no category-specific tooth counts or comparative estimates available for interpretation. The record also does not provide confidence intervals, p-values, or an account of the statistical methods used to analyze the endpoint.

The trial structure is not fully clear from the registry description. It is classified as parallel, while the brief summary describes both materials being placed in different teeth of each participant. The record does not reconcile those descriptions or explain whether the analysis accounted for observations from teeth within the same participant.

Follow-up information indicates that some units were not represented at the end of the study because of dropout and replaced restorations. The record reports completion and tooth counts at Visit 5 but does not describe reasons for missingness, the treatment of replacement restorations, or the method used to handle missing outcomes. It also does not report the analysis population.

Other details needed for a full assessment are not reported in the registry record, including who was masked, how allocation was concealed, the prespecified statistical plan, the multiplicity approach, and the original sample-size justification. These reporting gaps limit assessment of potential bias, precision, and the relationship between the planned endpoint and any eventual analysis. They do not, by themselves, indicate that a particular bias or analytic error occurred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative — NCT03032705.
• Registry record last updated 2021-12-13; status last verified 2021-11.
• Results first posted 2021-11-12.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The completed, randomized study compares SonicFill™ 2 with Filtek™ Supreme for dental restorations. The registry lists a single-masked, parallel model, while the brief summary describes each participant receiving both materials in different teeth. The primary endpoint counts teeth by rating across five esthetic categories, assessed from baseline up to two years after placement.

The endpoint description notes dropout and replacement, reports that 29 participants completed Visit 5, and gives the teeth represented for each material at that visit. The adverse-event entries list zero serious adverse events and zero deaths in both groups, with other adverse-event counts also recorded. Numerical results for the primary endpoint, the analysis methods, and the handling of missing data are not reported in the registry record.