This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment (NCT06369779), a na na study. The primary outcome is Postoperative Hypersensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06369779 |
| Phase | NA |
| Condition | Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 65 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ivoclar Vivadent AG |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with insufficient dental filling or primary caries in Class I or II cavities in premolars or molars. The registry record lists an enrollment of 65. It does not report further eligibility details or describe the characteristics of the participants enrolled.
Intervention
The restoration uses TM Fill, a new sculptable universal bulk-fill composite, in combination with TM Flow, a new flowable composite. The registry record describes their use together to restore the cavities.
Comparator
There is no comparison group in this single-arm study. The allocation is listed as NA, and the record does not identify a control treatment. Outcomes therefore describe restorations treated with the combination, rather than a relative effect against another material or approach.
Primary question
The primary endpoint is postoperative hypersensitivity at 1 month, measured in restorations using tests with thermal stimuli and occlusal forces during biting. The record describes assessment using a Visual Analog Scale and FDI criteria. It does not report the observed endpoint results.
3. Trial Design
This is a prospective, single-arm clinical study, listed as a device investigation with phase NA. The registry record lists enrollment of 65 and names Ivoclar Vivadent AG as the sponsor. The study evaluates TM Fill in combination with TM Flow for Class I and II cavity restorations. Because there is no separate control group, the design can describe clinical observations after use of this combination, but cannot directly compare those observations with a different restorative treatment.
Masking is listed as none. Allocation is listed as NA, consistent with the record's description of a single-group study rather than a randomized comparison. The status is active, not recruiting. The listed study start is 2024-05-13, and the listed primary completion is 2024-08-12. These registry dates do not establish that all planned follow-up assessments have been completed.
The brief summary describes assessment at baseline, defined as 7-10 days after placement, and at 1, 6, 12, 24, 36 and 60 months. The primary endpoint is postoperative hypersensitivity at 1 month. Secondary outcomes concern functional properties, such as fracture and retention; biological properties, such as caries at restoration margins; and aesthetic properties, such as color match. The record lists two outcome measures but no analysis count. It does not report how many participants or restorations contributed data at each follow-up, or whether every listed assessment occurred.
The study's single-arm structure is central to interpreting its findings. Any outcome rate would be an observation among restorations treated with the combination, not evidence of a difference relative to an untreated group or another product. No comparator treatment or randomized allocation is 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
| Stage | Test group (TM Fill in combination with TM Flow) |
|---|---|
| STARTED | 65 |
| COMPLETED | 64 |
| NOT COMPLETED | 1 |
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.
| Characteristic | Unit | Test group (TM Fill in combination with TM Flow) |
|---|---|---|
| Participants analysed | 65 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 65 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 38 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Postoperative Hypersensitivity, measured over 1 month.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Restorations |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is postoperative hypersensitivity at 1 month, reported for restorations. The description says sensitivity is assessed through tests using thermal stimuli and occlusal forces during biting. It refers to a Visual Analog Scale (VAS) from 0, meaning “No pain at all,” to 10, meaning “The worst pain imaginable,” and also describes FDI criteria on a scale from 1, “very good,” to 5, “unacceptable.” The listed FDI categories distinguish no complaint, minor complaint, distinct pain, persistent pain for a prolonged period, and a situation in which treatment is unavoidable.
In general, an endpoint makes a clinical question measurable by specifying what is assessed and when. Postoperative sensitivity is relevant to evaluating the experience associated with a restoration, while the FDI categories provide a way to characterize the severity of complaints. The endpoint description includes both the VAS and FDI scales, but does not explain how their scores are combined, whether one is primary to the other, or how the endpoint is summarized across restorations. Those details are not reported in the registry record.
The record specifies the planned endpoint and assessment time, but does not report an observed score, the number of restorations assessed at 1 month, or a summary of the results. The endpoint description alone therefore does not establish how much hypersensitivity was observed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes an evaluation of a restorative material combination, not a controlled test of whether that combination performs better than another treatment. Its single-arm design means that reported observations, if available, would describe the treated restorations over time. Without a concurrent comparison group, differences from another product or from usual care cannot be estimated directly from this design.
The primary outcome is postoperative hypersensitivity assessed at 1 month. The registry record does not report observed values for this outcome. It also does not report numerical results for the listed functional, biological or aesthetic outcomes. Although the brief summary describes scheduled assessments from baseline through 60 months, planned follow-up points should not be mistaken for completed assessments or available results. The study status is active, not recruiting, and the record lists no analyses.
The adverse-event information lists 65 at risk in the test group, with 0 serious events, 0 other events and 0 deaths. These figures are registry-record counts for the group. They are not estimates of comparative safety, because no control group is reported. A zero count in the record should be read as no events recorded in the listed category, rather than proof that an event is impossible or that no unrecorded event occurred. The record does not list serious adverse-event terms.
Precision cannot be judged for the primary endpoint from the registry information because its observed estimate and uncertainty interval are not reported. In general, a confidence interval conveys the range of values reasonably compatible with data under the analysis assumptions; its width helps readers assess precision. Here, no endpoint estimate or interval is available to interpret. The record also does not provide the analysis method or outcome denominators needed to understand how any future result would be calculated.
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Those assumptions are not a description of this single-arm study's own design: no two-arm allocation is reported. The registry record does not report the observed effect or the resulting planning counts, nor does it report a sample-size justification for this trial. Such illustrations are planning calculations, not observed power and not evidence of an effect.
Overall, the record identifies what the investigators intend to evaluate and the follow-up schedule they describe, but does not supply clinical outcome results. Conclusions about the observed level of hypersensitivity, restoration performance, or comparative safety are therefore not supported by the posted results in this record.
9. Statistical Methods Explained
What can a single-arm study estimate?
In general, a single-arm study can describe outcomes observed among participants or treated units that receive the study intervention. Here, the intervention is TM Fill in combination with TM Flow, and the primary endpoint is assessed in restorations. Such descriptions can help characterize what was recorded under the study conditions. They do not by themselves estimate a treatment contrast, because there is no separate group receiving a comparator. Changes over follow-up can also reflect factors other than the intervention, so a before-and-after pattern is not equivalent to a randomized comparison.
The record lists allocation as NA and masking as none. It identifies the model as single group. These design features do not establish whether outcome assessors were independent or whether any particular procedures were used to reduce measurement bias; those details are not reported in the registry record. The record also does not describe a statistical analysis plan.
What does an endpoint scale represent?
In general, a scale translates an observation into a defined set of values or categories. The endpoint description names both a VAS and FDI criteria. The VAS anchors run from “No pain at all” to “The worst pain imaginable,” while the FDI criteria classify complaints from no complaint through increasing degrees of pain and treatment need. A score or category can be useful only when the method for recording and summarizing it is clear. The registry record does not explain how the VAS and FDI assessments relate to one another in the primary analysis, or whether results would be summarized as scores, categories, or another measure.
The endpoint is recorded for restorations, not explicitly as a participant-level measure. A participant may contribute more than one restoration, but the registry record does not describe the number of restorations per participant or how dependence among multiple restorations would be handled. In general, observations from the same participant can be correlated rather than independent. An analysis that treats correlated observations as independent can give uncertainty estimates that are too small. The record does not report whether this issue applies or how it would be addressed.
How should uncertainty and significance be read?
In general, a point estimate gives a single summary of an observed outcome, while a confidence interval indicates the uncertainty around that estimate under the chosen statistical method. A narrow interval indicates greater precision than a wide interval, although precision is not the same as clinical importance. A p-value, when reported, describes how compatible the data are with a specified null model and its assumptions; it is not the probability that a treatment works or does not work. No primary endpoint estimate, confidence interval or p-value is reported in this registry record, so none can be interpreted for the study.
The sample-size assumptions refer to a two-sided significance level of 0.05 and a normal approximation. In general, a planning calculation uses assumptions about the effect to be detected, variability and design to illustrate a target sample size. It does not establish the size of an effect actually observed. The stated illustration assumes equal allocation between two arms, whereas the trial is listed as single group. The registry record does not report a trial-specific sample-size justification or calculated planning figures. Any planning sample sizes should be understood as illustrations, not as observed power or as evidence about the study result.
Why can over-dispersion matter?
In general, over-dispersion means that observed variability is greater than a statistical model expects. If an analysis assumes less variability than the data contain, standard errors and confidence intervals can be misleading, and tests can overstate the strength of evidence. Whether over-dispersion is relevant depends on the outcome and the analysis model. The registry record does not report the model used for the primary endpoint, its distributional assumptions, or any assessment of over-dispersion. It would therefore be inappropriate to claim that a particular adjustment was or was not used.
What can be inferred from the listed safety counts?
Counts of events are descriptive unless their definitions, observation periods, and denominators are clear. The record lists the test group with 65 at risk for serious and other adverse events, and reports 0 in each affected-event count and 0 deaths. In general, an event count does not itself describe the time each person or restoration was observed, and a count without a comparison group cannot estimate a relative risk. The record does not report event ascertainment details, exposure time, or a comparative safety analysis. The zero counts should therefore be read as the recorded counts, not as proof of absence of risk.
The registry record lists no analyses. It does not specify methods for handling repeated assessments, clustering of restorations within participants, missing outcomes, or multiplicity. These omissions limit how much can be inferred about the intended statistical treatment of the scheduled outcomes.
10. Multiplicity, Missing Data and Analysis Populations
The study description includes a primary endpoint and secondary outcomes covering functional, biological and aesthetic restoration properties. Assessments are scheduled at baseline and at multiple follow-up times through 60 months. Considering several outcomes or time points creates a multiplicity issue: in general, the more statistical comparisons made, the greater the chance that at least one appears notable by chance if each is assessed separately. This is why an analysis plan may identify a primary comparison or specify adjustment procedures. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or which follow-up times would be used for formal testing.
The record lists two outcome measures and no analyses. It does not report how missing observations would be handled, whether an analysis would use all available assessments, or how withdrawals and incomplete follow-up would be described. Because the planned follow-up extends through 60 months, the number of observations available may differ across assessment times; actual completion and missingness are not reported.
Analysis populations are also not defined in the registry record. It does not say whether the primary analysis would include all enrolled participants, only those with a placed restoration, or another defined group. Nor does it state how restorations within the same participant would be treated. These details matter because the unit of the primary outcome is restorations, while the enrolled population is described in participants. Without reported denominators and analysis rules, an outcome summary would be difficult to interpret fully.
These are reporting gaps, not evidence that a particular method was omitted from the underlying study conduct. The statistical plan, missing-data methods, analysis populations and multiplicity procedures are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Test group (TM Fill in combination with TM Flow) | 0 | 65 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test group (TM Fill in combination with TM Flow) | 0 of 65 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Test group (TM Fill in combination with TM Flow) | 0 of 65 |
The adverse-event record lists 65 at risk in the test group. It records 0 serious adverse events, 0 other adverse events and 0 deaths, and lists no serious adverse-event terms. These are the counts recorded for the group, not comparisons with another treatment. The study is single arm, so the record cannot establish whether event frequency differs from that under another approach.
In general, a zero event count means that no event in that category was recorded in the data represented by the count. It does not demonstrate that the underlying risk is zero, and it does not show whether all participants were observed for the same duration. The record does not specify adverse-event collection procedures, exposure time, or whether the counts are participant-based or restoration-based. The at-risk count and the event count should therefore be read as registry summaries, not as a complete assessment of safety.
The study's primary endpoint is postoperative hypersensitivity, but the adverse-event counts do not report that endpoint's result. The registry record provides no numerical result for hypersensitivity at 1 month. The event counts should not be used as a substitute for those outcome data.
12. What the Result Does, and Does Not, Mean
This registry record describes a prospective study of TM Fill used with TM Flow for Class I and II cavity restorations. It identifies postoperative hypersensitivity at 1 month as the primary endpoint and describes further evaluation of restoration function, biological properties and aesthetics over follow-up. It also records zero serious events, zero other events and zero deaths in the test group. These details describe the study's purpose and the safety counts entered in the record.
The record does not report observed results for postoperative hypersensitivity or the listed restoration outcomes. It therefore does not establish the amount of sensitivity observed, how restorations performed over time, or whether any outcome changed across assessments. The listed schedule is a plan described in the brief summary; it does not show that every follow-up has been completed or that results are available.
The single-arm design also sets an important boundary on interpretation. Without a control group, outcomes cannot show how the material combination compares with another material or treatment. The record does not describe randomized allocation or masking. Any eventual result would need to be interpreted as an observation in the studied setting, with attention to outcome definitions, participant and restoration denominators, follow-up, and the analysis methods.
The zero adverse-event counts should not be treated as proof of no risk. They refer to events recorded in the registry summary and do not provide a comparative estimate or a full account of event surveillance. Likewise, planning illustrations based on assumed effects are not clinical findings and do not replace observed results.
In short, the registry record identifies a clinical question and a planned assessment framework, but does not report the endpoint outcomes needed to answer that question. It supports neither a claim of benefit nor a claim of lack of benefit. Results and sufficient analytical detail would be needed for an evidence-based assessment of performance and uncertainty.
13. Why This Trial Matters Statistically
Restorative materials are evaluated through more than one dimension. The registry record identifies postoperative hypersensitivity as the primary endpoint and also describes functional, biological and aesthetic properties. Tracking these domains over time can provide a broader description of restorations than a single measure alone. The stated schedule extends from an early baseline assessment through longer-term follow-up, which makes clarity about assessment timing and completion important.
The study is also statistically instructive because it is single arm. Descriptive outcomes from treated restorations can be useful, but they do not answer the same question as a randomized comparison. Without a control group, readers cannot separate outcomes associated with the material combination from other explanations or estimate a comparative treatment effect. This distinction is essential when interpreting clinical evidence.
The endpoint description raises a further measurement issue: it names both a VAS and FDI criteria. Clear reporting of how these measures are used and summarized helps readers understand what a reported result represents. Likewise, identifying whether the analysis is participant-based or restoration-based, and how repeated observations are handled, can affect estimates and their precision. Those methods are not reported in the registry record.
The record's absence of outcome analyses is itself relevant. A planned schedule and a named endpoint do not constitute evidence of an observed result. Readers need outcome estimates, denominators, uncertainty measures and analysis details to judge what the study found. The registry entry currently provides useful context about the intended evaluation, while leaving the clinical findings and their precision unreported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this study follow from the registry description. It is a single-arm study with no reported comparator, so it cannot directly estimate a difference between TM Fill in combination with TM Flow and another treatment. Masking is listed as none, and the record does not say whether outcome assessors were independent or whether any other steps were used to limit assessment bias.
The primary endpoint description refers to both a VAS and FDI criteria, but does not explain how the two are related in the analysis. The outcome is specified for restorations, while enrollment is stated in participants; the record does not describe how many restorations each participant contributes or how observations within a participant are handled. These reporting gaps make it difficult to assess the intended measurement and analysis units.
Although follow-up is described through 60 months, the record does not report completed assessments, outcome denominators at each time point, or missing-data methods. The study is listed as active, not recruiting, and no analyses are reported. The listed primary completion date does not by itself establish that longer-term follow-up or analysis is complete.
The record does not report a trial-specific sample-size justification, a statistical analysis plan, or methods for multiplicity. It also does not report endpoint estimates or uncertainty intervals. These omissions limit evaluation of precision, the handling of multiple outcomes and the robustness of any eventual result. They should be understood as limitations of what is reported in the registry record, not as proof that methods were absent from study conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment — NCT06369779.
- Registry record last updated 2025-10-23; status last verified 2025-07.
- Results first posted 2025-05-31.
- 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.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a prospective, single-arm device study of TM Fill in combination with TM Flow for Class I and II cavity restorations. Enrollment is listed as 65, allocation as NA, masking as none, and status as active, not recruiting. The primary endpoint is postoperative hypersensitivity at 1 month, assessed in restorations using thermal and occlusal stimuli, with VAS and FDI criteria described.
The brief summary lists baseline assessment 7-10 days after placement and follow-up at 1, 6, 12, 24, 36 and 60 months. Secondary outcomes concern functional, biological and aesthetic restoration properties. The adverse-event record lists 0 serious events, 0 other events and 0 deaths among the test group. The registry record does not report clinical outcome results, analysis methods, missing-data procedures or a comparator group.