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 A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration (NCT04063878), a na na study. The primary outcome is Prosthetic Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04063878 |
| Phase | NA |
| Condition | Jaw, Edentulous, Partially |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 160 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dentsply Sirona Implants and Consumables |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with partially edentulous jaws undergoing single-tooth restoration. The registry lists an enrollment of 160. The primary endpoint description specifies a per-protocol population of 144 and notes that visit data are missing for 13 participants. The record does not describe the eligibility criteria or provide further participant characteristics.
Intervention
The intervention is the Conometric Abutment and Conometric Final Cap, used in single-tooth restorations with the Acuris conometric concept. The stated concept retains the crown through friction when seated, without cement or screws. The registry identifies the intervention as a device.
Comparator
There is no separate comparator group in the listed design. The study is described as single-group, with no masking and allocation recorded as NA. As a result, the study record does not set up a like-for-like comparison against another treatment or a control condition.
Primary question
The primary question is whether the original permanent restoration meets the registry's criteria for prosthetic survival 1 year after permanent restoration. The criteria require the restoration to remain in place, retention between the abutment and final cap to be maintained, and no fracture or loss of the abutment. The record gives the endpoint definition but does not report how many restorations met these criteria.
The distinction between an endpoint definition and an endpoint result is important. The stated outcome is a count of permanent restorations classified as Yes or No according to the criteria, rather than a comparison of treatment groups or a time-to-event estimate. Although the official title describes a 5-year follow-up study, the primary endpoint timeframe in the registry is 1 year after permanent restoration. The registry also lists secondary outcomes covering prosthetic and implant survival, marginal bone-level alterations, bleeding on probing, plaque, and probing pocket depth. Results for these outcomes are not reported in the registry record.
3. Trial Design
The registry describes a prospective, multicenter, single-group device study of the Acuris conometric concept for single-tooth restoration. Its official title calls it a 5-year follow-up study, while the primary outcome is specified for assessment 1 year after permanent restoration. Enrollment is listed as 160. The record identifies Dentsply Sirona Implants and Consumables as the sponsor and lists the condition as partially edentulous jaw.
The study has no listed random allocation and no masking; the allocation entry is NA and masking is NONE. A single-group design means the listed study follows restorations using the Acuris concept without a separate control arm. Its findings can describe outcomes in that group, but the design does not itself provide a concurrent between-group estimate of the concept's effect. This is especially relevant when interpreting survival counts: without a control group, the record cannot separate outcomes associated with the device from other influences on those outcomes.
The registry status is active, not recruiting. The recorded start date is 2019-07-30 and the primary completion date is 2023-09-30. These registry entries do not establish when every participant received a restoration or completed follow-up. The protocol's sample-size justification, planned interim analyses, and detailed statistical analysis plan are not reported in the registry record.
The primary endpoint population is described as per protocol, with 144 participants and visit data missing for 13 participants. The record does not explain how the per-protocol population was defined, how participants with missing visit data were handled, or whether any other analysis populations were used. Seven outcome measures are listed, but no analysis entries are reported. Consequently, the registry supports a description of the design and outcome definitions, not a reconstruction of the analysis or a numerical conclusion about the primary outcome.
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 | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|
| STARTED | 160 |
| COMPLETED | 144 |
| NOT COMPLETED | 16 |
Reasons for not completing this period:
| Reason | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|
| Withdrawal by Subject | 2 |
| Subject not fulfilling study eligibility criteria | 14 |
Analysis population for the primary outcome, as defined in the registry: Per protocol 144 - Visit data missing for 13 participants.
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 | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|---|
| Participants analysed | 144 | |
| Age, Continuous | Years | 50.32 (SD 12.46) |
| Sex: Female, Male: Female | Participants | 79 |
| Sex: Female, Male: Male | Participants | 65 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Prosthetic Survival, measured over 1 year after permanent restoration.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Permanent restorations |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is prosthetic survival, measured as a count of permanent restorations and assessed 1 year after permanent restoration. The registry defines survival using several conditions together: the permanent restoration must remain in situ; retention between the abutment and final cap must not be lost; the abutment must not fracture; and the abutment must not be lost. A restoration is classified as Yes only when all these criteria are fulfilled. If the criteria are not all fulfilled, the endpoint's Yes definition is not met.
This combined definition is used to capture more than whether a crown remains physically present. It also reflects retention and abutment integrity, which are central features of the conometric concept described in the record. Bringing these conditions into one categorical endpoint makes the outcome clinically interpretable as a restoration meeting the prespecified survival criteria at the stated follow-up point. It also means that the endpoint depends on all listed components, not on any one component alone.
The record does not report the number classified Yes or No, nor an estimated survival proportion or uncertainty interval. It therefore establishes what the endpoint is intended to measure, but does not report the observed primary endpoint result. The listed per-protocol population is 144, with visit data missing for 13 participants; the registry does not describe how missing visit information affects endpoint classification.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record offers a defined primary outcome and a study population, but it does not report the primary outcome result. In particular, it does not state how many permanent restorations were classified as surviving at 1 year after permanent restoration. There is no reported estimate, confidence interval, test statistic, or p-value for that endpoint. Without those results, the record cannot establish the observed frequency of restorations meeting the survival criteria or the precision of an estimate.
The design is single-group, with no listed comparator. A single-group outcome can describe what happened among the restorations followed, but it cannot directly establish how outcomes compare with another restoration method or with a control group under the same study conditions. Differences in patient characteristics, follow-up, clinical practice, or other influences cannot be assessed through a randomized contrast when no comparator arm is listed. This limits causal interpretation independently of whether an outcome count is eventually reported.
The primary outcome is a categorical classification based on multiple requirements. A restoration must remain in situ, retain its conometric connection, and avoid abutment fracture or loss to meet the Yes definition. A result for the combined endpoint would not, on its own, show which individual component was most influential. The registry lists additional outcomes, including implant survival and measures of bone levels, bleeding, plaque, and probing pocket depth, but does not report their results either.
The per-protocol population is stated as 144, and the registry notes missing visit data for 13 participants. This raises an interpretive question about how much endpoint information was available and how the missing visits were handled. The record does not say whether those participants were excluded, counted as failures, assessed through another method, or included in a different analysis population. None of these approaches should be assumed. The total enrollment of 160 is not a substitute for a reported endpoint denominator.
The safety portion lists 4 serious adverse events among 160 at risk, 8 other adverse events among 160 at risk, and 0 deaths. These are descriptive counts; no comparison group or causal attribution is reported. The serious-event terms listed include COVID-19, renal colic, and hypotensive crisis and renal insufficiency, each with the registry's stated percentages. The counts should not be interpreted as proof that events were or were not caused by the device.
Overall, the posted record supports statements about the study's setup, endpoint definition, and recorded adverse-event counts. It does not support a numerical conclusion about prosthetic survival, a comparison with another treatment, or a claim of treatment effect. The absence of reported analyses should be kept distinct from evidence of no effect: no such effect estimate is available in the registry record.
9. Statistical Methods Explained
The registry identifies the primary outcome as a count of permanent restorations, with a binary Yes/No classification based on the endpoint criteria. This is not a continuous measurement such as a mean value, and it is not described as a time-to-event endpoint. The primary timeframe is 1 year after permanent restoration. The outcome definition specifies the conditions that must all be met for Yes, but a defined outcome does not itself tell readers how many observations met it.
What does a single-group design estimate?
In general, a single-group study can estimate or describe outcomes observed in the group being followed. A comparison of outcomes between treatment groups requires data from distinct groups and a suitable analysis of that contrast. Here, the listed model is single-group, and there is no listed comparator. A proportion of restorations meeting the survival definition, if reported, would describe the observed group at the stated assessment. It would not by itself quantify a difference from another treatment or prove that the device caused the outcome.
Random allocation is recorded as NA, and masking is recorded as NONE. These design entries matter because they describe the absence of a listed randomized assignment and masking procedure. The registry does not state that another method was used to address potential differences or observer influences. No adjustment strategy or other statistical method is reported, so none can be attributed to the study.
How should a confidence interval be understood?
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the method used to construct it. A narrower interval indicates greater statistical precision, while a wider interval indicates greater uncertainty. An interval would not remove limitations from a single-group design, and it would not correct missing outcome information or establish causality. The registry record does not report a confidence interval for prosthetic survival, so the precision of the primary endpoint estimate cannot be assessed from this record.
What does a p-value contribute?
In general, a p-value quantifies how compatible observed data are with a specified null model, assuming that model and the analysis assumptions. It does not measure the size or clinical importance of an effect, nor does it establish that an observed association is causal. For a single-group endpoint, the question being tested would depend on the stated hypothesis and statistical plan. Neither a primary endpoint p-value nor the testing plan is reported in the registry record. No significance conclusion should therefore be inferred.
Why does the analysis population matter?
The registry labels the primary population per protocol and gives its size as 144, while noting visit data missing for 13 participants. In general, a per-protocol analysis focuses on participants meeting defined protocol conditions, but the conditions and exclusions must be specified to understand the estimate. The record does not define the per-protocol criteria or describe whether the missing visits were excluded from the endpoint calculation. It also does not report an intention-to-treat analysis or another population-based analysis. Those approaches cannot be presumed.
What can be inferred from the adverse-event counts?
Counts and at-risk denominators are descriptive summaries. They report event burden in the listed study group but do not, on their own, compare risk with another group or identify cause. General safety interpretation also depends on definitions, duration of observation, event ascertainment, and whether counts refer to people or event episodes. The registry lists serious and other adverse-event counts and names selected serious-event terms, but does not report a comparative safety analysis or a causal assessment.
There are seven listed outcome measures and zero analysis entries. This means the registry record does not provide statistical estimates for those outcomes. The protocol's sample-size justification, planned interim analyses, and detailed analysis plan are not reported in the registry record. Accordingly, no planned test, model, adjustment, missing-data method, or multiplicity procedure can be described as having been used. Any explanation of statistical concepts in this discussion is general; it is not a claim about methods applied in the study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, including prosthetic survival, implant survival, marginal bone-level alterations, bleeding on probing, plaque, and probing pocket depth. It does not report the statistical analysis entries for these outcomes. The protocol's analysis plan and any approach to handling multiple outcomes are not reported in the registry record. In general, when several outcomes are tested, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. That general issue cannot be quantified for this study from the registry information.
The primary endpoint is explicitly identified, but no hierarchy or testing sequence for the other outcomes is stated. No interim analyses are reported in the registry record. This should not be read as evidence that interim analyses were or were not conducted; the registry simply does not report them. Without an analysis plan or results, there is no basis for describing a multiplicity adjustment or the interpretation of any secondary-outcome tests.
For the primary endpoint, the registry describes a per-protocol population of 144 and says visit data are missing for 13 participants. It does not define the per-protocol criteria, explain the reason for missing visits, or report the method used to handle missing endpoint information. In general, excluding missing observations, treating them as failures, and using an imputation method can lead to different estimates and rely on different assumptions. None of these approaches is stated in the registry record.
The registry also does not report a separate analysis population or sensitivity analyses that might show how conclusions change under alternative missing-data assumptions. Consequently, the effect of missing visits on the primary endpoint estimate cannot be assessed. The total enrollment of 160 should not be taken as the denominator for the primary endpoint, since the stated primary population is per protocol and the endpoint result and denominator are not reported.
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 |
|---|---|---|---|
| Single Tooth Restorations Using Acuris Conometric Concept | 4 | 160 | 2.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Single Tooth Restorations Using Acuris Conometric Concept | 0 of 160 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Single Tooth Restorations Using Acuris Conometric Concept | 8 of 160 |
Most frequent serious adverse event terms
| Event term | Organ system | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|---|
| COVID-19 | Infections and infestations | 2 of 160 |
| Renal colic | Renal and urinary disorders | 1 of 160 |
| Hypotensive crisis and renal insufficiency | Renal and urinary disorders | 1 of 160 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Single Tooth Restorations Using Acuris Conometric Concept |
|---|---|---|
| Loss of conometric retention between abutment and final cap | Product Issues | 8 of 160 |
Serious events with the highest arm-level rate: covid-19 (1.2%), renal colic (0.6%), hypotensive crisis and renal insufficiency (0.6%).
The adverse-event entry lists 4 serious adverse events among 160 at risk and 8 other adverse events among 160 at risk in the single study group. It also records 0 deaths. These are counts in the registry record, not comparisons between treatment arms. The listed serious-event terms are COVID-19 at 1.2%, renal colic at 0.6%, and hypotensive crisis and renal insufficiency at 0.6%.
The counts should be read descriptively. The registry does not provide a control group, a comparative risk estimate, or an attribution analysis that would determine whether an event was caused by the device or another factor. The listed terms and percentages do not show the full clinical context, duration of follow-up for each person, or whether a person could contribute more than one event. Those details are not reported in the registry record.
Serious and other adverse events are separate categories in the record; their counts should not be added to produce a total number of affected participants. The record does not explain whether the counts represent unique participants or event episodes. Likewise, 0 deaths is the recorded count and should not be expanded into a claim about safety beyond the registry's reporting. These data describe what is recorded, not a comparative or causal safety conclusion.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective, multicenter, single-group study was designed around the Acuris conometric concept for single-tooth restoration. It defines prosthetic survival using the restoration's presence, retention, and abutment integrity at 1 year after permanent restoration. It also reports an enrollment of 160, a per-protocol population of 144 with visit data missing for 13 participants, and descriptive adverse-event counts.
It does not report the number of restorations that met the primary survival criteria. Therefore, the primary result and its statistical precision are unknown from the registry record. No estimate, confidence interval, or p-value is reported. The absence of these results should not be interpreted as a favorable result, an unfavorable result, or evidence that the endpoint was unchanged.
The single-group design also limits what a result could establish. Even if a survival count were reported, it would describe the study group rather than provide a randomized comparison with another method. It could not, by itself, establish how the concept performs relative to a control or attribute outcomes to the device. The secondary outcomes are named but their results are not reported in the registry record.
The primary endpoint is a composite categorical definition: all listed conditions must be fulfilled for a Yes classification. A result for that endpoint would not necessarily explain each component separately. The record does not report component-level results, missing-data methods, detailed analysis methods, or a sample-size justification. These absences restrict assessment of the estimate's robustness and the intended statistical precision.
The adverse-event counts likewise do not establish causation or comparative safety. They are recorded for the study group, with no separate control group. A careful reading therefore separates the information the registry does provide—design, outcome definitions, population notes, and safety counts—from questions that remain unanswered, especially the actual primary endpoint result and its uncertainty.
13. Why This Trial Matters Statistically
This study raises several useful statistical reading questions for clinical researchers. First, a clearly defined endpoint is not the same as a reported outcome. The registry specifies a demanding, multi-condition definition of prosthetic survival, but does not give the number of restorations meeting it. Readers need both the rule used to classify an outcome and the observed data to understand what happened.
Second, design determines the kinds of conclusions an analysis can support. A single-group study can describe outcomes in its participants, but a concurrent comparator is needed for a direct between-group contrast. The registry lists no comparator and no random allocation. That distinction remains important even if a numerical survival estimate is reported elsewhere: descriptive performance in one group is not the same as a treatment-effect estimate.
Third, follow-up and analysis populations shape interpretation. The official title describes a 5-year follow-up study, while the primary endpoint is set at 1 year after permanent restoration. The record also specifies a per-protocol population and missing visit data. These details prompt questions about the time point, denominator, exclusions, and handling of missing observations. The registry does not answer those questions.
Finally, safety counts and outcome definitions should not be mistaken for inferential results. The adverse-event figures describe the listed group but do not compare risks or assign causation. With seven outcomes listed and no analysis entries, the registry does not show how multiple outcomes were handled. The statistical lesson is to distinguish what a record documents from what an analysis might establish: definitions and counts are informative, but they cannot replace outcome estimates, uncertainty measures, and transparent methods.
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 main trial-specific limitation in the registry record is the absence of a reported primary endpoint result. Although prosthetic survival is defined and a per-protocol population is identified, the number of restorations classified Yes or No is not reported. No estimate of uncertainty is available, so neither the observed outcome frequency nor its precision can be assessed.
The single-group design has no listed comparator. This prevents a direct within-study comparison against another treatment or control condition and limits causal interpretation. The study is described as multicenter, but the registry does not provide center-specific results or state how center variation was handled. The record also does not report participant eligibility details, baseline characteristics, or the distribution of restorations across sites.
The registry identifies a 5-year follow-up study by title, while the primary endpoint timeframe is 1 year after permanent restoration. It does not provide the full follow-up schedule or state what results were available at other time points. The primary population is described as per protocol, with visit data missing for 13 participants, but the reasons for missing visits and their handling are not reported. The per-protocol criteria are also not defined.
The record does not report the analysis plan, sample-size justification, interim analyses, statistical methods, multiplicity approach, or sensitivity analyses. Seven outcome measures are listed, but no analysis entries are reported. These omissions make it impossible to evaluate the planned inferential framework or the robustness of any outcome estimate from the registry record. The adverse-event entry is descriptive and does not report comparative or causal safety analyses. These are limits on what can be concluded from the registry record, rather than evidence that a particular result or method was absent from the full study materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration — NCT04063878.
- Registry record last updated 2026-09-18; status last verified 2026-08.
- Results first posted 2025-03-05.
- 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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18. Record Summary
The registry record describes a prospective, multicenter, single-group study of the Acuris conometric concept for single-tooth restoration. The intervention is the Conometric Abutment and Conometric Final Cap. Enrollment is 160, allocation is recorded as NA, masking is NONE, and the study status is active, not recruiting.
The primary outcome is prosthetic survival, defined by the restoration remaining in situ, retention being maintained, and no fracture or loss of the abutment, assessed 1 year after permanent restoration. The primary population is listed as per protocol 144, with visit data missing for 13 participants. The number meeting the survival definition and any associated statistical estimate are not reported in the registry record.
The record lists 7 outcome measures and 0 analysis entries. Safety counts are 4 serious adverse events and 8 other adverse events among 160 at risk, with 0 deaths. These counts are descriptive; the record provides no comparator or causal safety assessment. The sample-size justification and detailed statistical analysis plan are not reported in the registry record.