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 BRIUS Vs FFA Efficiency (NCT04347018), a randomized na study. The primary outcome is Overall 3D Movement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04347018 |
| Phase | NA |
| Condition | Dental Malocclusion, Angle Class II, Angle Class I |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 13 |
| Arms in the primary outcome | 2 |
| Lead sponsor | State University of New York at Buffalo |
| Results posted | Yes |
2. Clinical Question
Population
The record describes patients receiving orthodontic treatment at the University at Buffalo Orthodontic Clinic. The listed conditions include dental malocclusion, Angle Class II, Angle Class I and tooth crowding. The enrolled total was 13; further eligibility details and a more specific description of the analysed population are not reported in the registry record.
Intervention
BRIUS was the intervention. The record describes a BRIUS orthodontic appliance, or wire, engaged to regular orthodontic brackets to initiate treatment.
Comparator
The comparison group received a preadjusted edgewise full fixed appliance, described as regular orthodontic brackets with standard orthodontic wires.
Primary question
At 18 weeks, what was the extent of tooth movement, measured in millimeters, in each group? The primary outcome was absolute 3D movement, summarized using medians and an interquartile-range framework.
The central statistical question is descriptive as well as comparative: what movement values were recorded in each randomized group, and how much evidence does the posted information provide about a between-group difference? The registry reports a median of 1.46 mm for the 7 participants in the BRIUS group and a median of 1.41 mm for the 6 participants in the preadjusted edgewise group. These are group summaries, not an estimate of the difference between treatments. A formal two-arm comparison was not estimable from the posted results. The figures therefore describe the observed endpoint in each group but do not establish the size or precision of a comparative effect.
3. Trial Design
This was a randomized, parallel-group clinical trial recorded as single-masked. The official title describes it as a single-center trial, and the treatment descriptions place care at the University at Buffalo Orthodontic Clinic. The registry lists an enrollment of 13 participants: 7 in the BRIUS group and 6 in the preadjusted edgewise full fixed appliance group. The study status is completed. The registry records a start date of 2020-07-06 and a primary completion date of 2022-06-17.
The two groups received different orthodontic appliance systems. BRIUS was described as an appliance or wire engaged to regular orthodontic brackets. The comparator was described as regular orthodontic brackets with standard orthodontic wires. The registry lists BRIUS as a device intervention. Details of how randomization was generated or implemented, including sequence generation and allocation concealment, are not reported in the registry record. The identity of the masked party and the procedures used to maintain masking are also not reported in the registry record.
The primary outcome was overall 3D movement, measured in millimeters at 18 weeks. The registry specifies a median and an interquartile-range approach to describing this outcome. It reports a median for each group, but the posted results do not provide an estimable two-arm comparison. The record lists 3 outcome measures and 0 analyses; details of other outcome measures are not reported in the registry record. The protocol’s planned statistical analysis, analysis populations, handling of missing measurements and any interim analyses are not reported in the registry record. The reported group sizes and outcome summaries should therefore be read as the information available in the results record, not as a complete account of the trial’s analysis plan.
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 | BRIUS | Preadjusted Edgewise Full Fixed Appliance |
|---|---|---|
| STARTED | 7 | 6 |
| COMPLETED | 7 | 6 |
| NOT COMPLETED | 0 | 0 |
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 | BRIUS | Preadjusted Edgewise Full Fixed Appliance | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 6 | 13 | |
| Age, Categorical: <=18 years | Participants | 7 | 6 | 13 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 2 | 3 | 5 |
| Sex: Female, Male: Male | Participants | 5 | 3 | 8 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Overall 3D Movement, measured over 18 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | mm |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, called overall 3D movement, is an absolute measurement of the extent of movement of teeth. It is expressed in millimeters and assessed at 18 weeks. In general, an absolute movement measure describes the magnitude of movement rather than its direction. The record does not give further detail about the measurement procedure, which teeth contributed to the endpoint, or how the individual measurements were combined into a participant-level value.
The registry specifies the median as the summary measure and the interquartile range as the dispersion measure. In general, the median is the middle value when observations are ordered, and the interquartile range describes the spread of the central half of those observations. These summaries can be useful when data are skewed or when a small number of values are unusually large or small. The posted results report medians of 1.46 mm for BRIUS and 1.41 mm for the preadjusted edgewise appliance. A dispersion value matching the specified interquartile-range summary is not reported in the registry record.
Tooth movement is the endpoint chosen for the comparison of the appliance systems in this trial. It describes a measured change in position, but the registry record does not report how that measure relates to other treatment outcomes or patient experience. No conclusion about those other outcomes can be drawn from this endpoint alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome values are medians of 1.46 mm for BRIUS and 1.41 mm for the preadjusted edgewise full fixed appliance at 18 weeks. The corresponding group sizes are 7 and 6. These values convey the central observed movement in each group under the registry’s stated summary approach. They do not, by themselves, quantify the uncertainty around the difference between groups or show whether an observed contrast is compatible with a range of possible effects.
The registry does not report an estimable two-arm comparison for this endpoint. There is no posted comparative effect estimate or inferential result to interpret. In particular, the record does not provide a confidence interval or a p-value for the between-group contrast. The numeric medians should not be treated as evidence that one appliance produces more or less movement than the other: interpreting a contrast requires an appropriate comparison and an assessment of its uncertainty, neither of which is available in the posted results.
Even where an outcome is reported for each group, the small group sizes mean that the observed summaries represent a limited set of participants. In general, small samples can produce unstable estimates, and a median alone does not show how much the individual participant values vary. The interquartile-range summary is specified in the registry, but its values are not reported in the registry record. The record also does not describe the measurement method or any adjustment for baseline characteristics. These omissions limit how fully the group summaries can be understood.
Randomization is the design feature intended to support a fair comparison by allocating participants to treatment groups without choosing their treatment based on anticipated outcome. However, the registry does not describe how randomization was conducted, and the posted endpoint results do not include an adjusted or unadjusted comparative estimate. Thus, the design label alone cannot substitute for a reported analysis.
The safety results list no serious adverse events, other adverse events or deaths in either group. These are the recorded counts in groups of 7 and 6 participants. They describe what was recorded in this trial; they are not a precise estimate of the frequency of uncommon events and should not be read as proof that no such events can occur.
Overall, the record gives descriptive medians for tooth movement and event counts, but not a completed inferential comparison of the primary endpoint. The most defensible reading is limited to those posted observations. Whether the groups differ, by how much, and with what precision is not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is summarized by medians rather than means. In general, a median is the central observation after values are put in order; it is less affected than a mean by an unusually high or low observation. This can be a practical summary when distributions are skewed or when there are few observations. The registry identifies the interquartile range as the measure of dispersion. In general, that range captures the spread between the lower and upper quartiles and describes the central half of observed values. The record gives the group medians but does not report the interquartile-range values, so the reported central values cannot be accompanied by the specified description of within-group spread.
A descriptive summary is different from a comparative analysis. The medians of 1.46 mm and 1.41 mm are calculated within the BRIUS and preadjusted edgewise groups, respectively. A comparative analysis would estimate how the outcome differs between the groups and would ordinarily communicate uncertainty around that estimate. The registry says values were missing or not estimable for a two-arm comparison for this endpoint. Therefore, no comparative estimate, confidence interval or p-value is available to explain. General statistical practice would not treat the visual or arithmetic contrast between two medians as a substitute for a prespecified comparative analysis.
A confidence interval, in general, is a range produced by a statistical procedure to express uncertainty around an estimate. Its width depends on factors such as the variability in the data, the amount of information available and the analysis method. A confidence interval for the group contrast is not reported in the registry record. Without such an interval, readers cannot use the posted endpoint results to assess which comparative effects remain reasonably compatible with the data. A p-value is also not reported for this comparison, and its absence should not be filled in by inference from the group summaries.
The study is recorded as randomized and parallel-group. In general, random allocation is intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics, but randomization does not guarantee balance in every small trial. The group sizes are 7 and 6. Details of the randomization procedure, concealment of allocation, baseline outcome values and baseline group characteristics are not reported in the registry record. The record also does not identify a specific analysis population, such as all randomized participants or participants with an observed endpoint. These details matter for judging how the results relate to the randomized comparison.
The posted endpoint is an absolute movement measure in millimeters, summarized at 18 weeks. In general, an endpoint’s interpretation depends on how it is measured and summarized, whether measurements are available for all randomized participants, and whether the analysis accounts for the trial design. The registry does not describe how tooth movement was measured, how multiple tooth measurements were combined, or how missing endpoint observations were handled. It also does not report whether any model adjusted for other variables. A detailed statistical analysis plan is not reported in the registry record.
Sample-size calculations are planning exercises, not summaries of what the observed data establish. The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups and a normal approximation. It says the illustrated effect is a stated fraction of the observed effect. In general, such calculations ask how many participants might be needed under specified assumptions to detect a target effect at a chosen power. Those assumptions do not establish the trial’s original design rationale, and the illustrations are not observed power. The trial’s own sample-size justification is not reported in the registry record. The registry record does not report numeric sample-size requirements for these illustrations.
Over-dispersion is a general issue in statistical models for counts or rates: the data may vary more than a model’s assumptions allow, which can make uncertainty estimates too small if not addressed. It is not possible to determine from the primary outcome summary whether such an issue applies; the endpoint is reported as a continuous movement measure, and the record does not provide a fitted model. No model choice or diagnostic assessment is reported in the registry record.
Multiplicity refers, in general, to the increased chance of false-positive findings when several hypotheses are tested. The record lists 3 outcome measures but reports 0 analyses and no secondary outcome results. The planned testing strategy and any adjustment for multiple comparisons are not reported in the registry record. Consequently, there is no basis for reconstructing a multiplicity procedure or interpreting a family of statistical tests.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures, but it reports 0 analyses and 0 secondary outcomes posted. The primary outcome is described as overall 3D movement at 18 weeks. The other outcome definitions and their results are not reported in the registry record. A complete list of planned hypotheses and a plan for controlling multiplicity are also not reported in the registry record.
In general, testing several outcomes or time points can increase the chance of obtaining at least one apparently notable result by chance. Statistical plans may address this through a prespecified hierarchy, adjustment, or a clear distinction between primary and exploratory outcomes. The registry record does not say whether any such approach was planned. Since no inferential analysis is posted for the primary endpoint, there are no reported tests whose multiplicity adjustment can be assessed.
The registry reports the enrolled total and the number of participants in each group, but it does not report the number with available primary endpoint measurements or define the analysis population. Missing endpoint data, exclusions after randomization, and the handling of missing observations are not reported in the registry record. It is therefore not possible to tell whether the posted group summaries include every randomized participant or only those with an observed measurement.
Details of interim analyses, stopping rules, protocol deviations and analysis-plan changes are not reported in the registry record. These omissions do not establish that such procedures were used or not used; they mean their role cannot be evaluated from the record. The distinction matters because analysis choices influence how an estimate should be interpreted and whether findings can be compared with a planned analysis.
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 |
|---|---|---|---|
| BRIUS | 0 | 7 | 0.0% |
| Preadjusted Edgewise Full Fixed Appliance | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| BRIUS | 0 of 7 |
| Preadjusted Edgewise Full Fixed Appliance | 0 of 6 |
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 |
|---|---|
| BRIUS | 0 of 7 |
| Preadjusted Edgewise Full Fixed Appliance | 0 of 6 |
The registry reports zero serious adverse events among 7 participants in the BRIUS group and zero among 6 participants in the preadjusted edgewise full fixed appliance group. It also reports zero other adverse events in each group and zero deaths in each group. No leading serious adverse-event terms are listed.
These figures are event counts as recorded for this trial. They do not mean that the groups had identical safety profiles, nor do they establish that the chance of an event is zero. With small groups, a trial may provide little information about uncommon events. In general, observing no events in a study does not rule out events that might occur in a larger population or over a different period of observation.
The registry record does not provide further detail about adverse-event definitions, collection procedures, severity grading, relatedness assessment or the duration of safety monitoring. The figures should therefore be read as the posted counts, not as a comprehensive characterization of safety. They also do not replace the primary endpoint results or support a conclusion about comparative safety beyond the recorded event counts.
12. What the Result Does, and Does Not, Mean
The record establishes that this completed randomized trial compared BRIUS with a preadjusted edgewise full fixed appliance and reported an 18-week measure of overall 3D tooth movement. It provides group medians of 1.46 mm and 1.41 mm, with 7 and 6 participants in the respective groups. It also records zero serious adverse events, zero other adverse events and zero deaths in each group.
Those observations do not establish a treatment difference. The registry does not report an estimable two-arm comparison for the primary endpoint, and no comparative effect estimate, confidence interval or p-value is posted. The two medians are separate summaries, not a direct estimate with uncertainty of how the groups differ. The registry also does not report the interquartile-range values, although it identifies the interquartile range as the intended dispersion summary.
In general, statistical evidence for a treatment contrast depends on the outcome data, the comparison method and the uncertainty around the estimate. A small trial can be informative about feasibility and can contribute observations, but its group summaries alone cannot show how precisely a comparative effect has been estimated. The record does not include the details needed to assess endpoint completeness, analysis populations, baseline balance or adjustment methods.
The safety counts likewise have a limited interpretation. Zero recorded events in these groups describes the registry entries, but does not prove that an event is impossible or that event rates are the same between groups. The record does not give the methods used to collect or classify adverse events.
The appropriate conclusion is therefore descriptive: the registry reports the stated movement medians and safety counts for the enrolled groups. It does not report enough comparative analysis to determine the magnitude, direction or precision of a between-group effect. No clinical recommendation follows from these posted results alone.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between reporting outcome values and reporting a statistical comparison. Group medians can describe the observed data, but they do not answer by themselves whether the groups differ or how uncertain that difference is. The registry lists the median movement in each arm, yet says a two-arm comparison was not estimable. That makes the limits of the available evidence central to statistical interpretation.
The record also highlights why summaries should be interpreted with their dispersion information. A median identifies a central value, while the interquartile range would describe how the central portion of observations is distributed. Although the record specifies an interquartile-range approach, it does not report those values. Without them, readers have less information about variation among participants and cannot judge how representative either median may be of the group’s individual outcomes.
The small enrolled groups make clarity about analysis especially important. In general, estimates based on few participants can be imprecise, and observed differences can be sensitive to individual observations. A transparent account of endpoint availability, the planned analysis population and the method used to estimate a treatment contrast would help readers assess the evidence. Those details are not reported in the registry record.
Finally, the record separates planning assumptions from results. Sample-size illustrations based on an observed effect are not the same as a trial’s prospective design justification, and they are not observed power. The record explicitly characterizes its calculations as planning illustrations. This distinction is useful when interpreting completed trials: calculations can describe hypothetical planning scenarios, but they cannot replace a reported analysis of the trial’s actual data.
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 posted primary outcome information is incomplete for a comparative interpretation. Group medians are reported, but a two-arm comparison is not estimable in the registry results. The interquartile-range values, confidence interval and p-value are not reported in the registry record. The record therefore does not show the uncertainty around the primary endpoint contrast.
The enrolled total was 13, split between groups of 7 and 6. Such limited group sizes constrain how much can be learned about variability and less common events. The record does not report whether all randomized participants contributed an endpoint measurement, how missing data were handled, or which participants were included in the analysis. This makes it difficult to assess the completeness of the primary outcome summaries.
Several design and measurement details are also absent. The procedure used to generate and conceal random allocation, the identity of the masked party, baseline characteristics, and the method for measuring and combining tooth movements are not reported in the registry record. A detailed protocol, statistical analysis plan, sample-size justification, interim-analysis plan and multiplicity strategy are likewise not reported.
The registry lists 3 outcome measures but posts no secondary outcomes and no analyses. This limits interpretation beyond the primary outcome and leaves the role of any additional planned measures unclear. The safety results are counts without further information about event definitions, collection methods or follow-up for safety. These gaps should be understood as limits of what the registry record reports; they do not establish what may or may not have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BRIUS Vs FFA Efficiency — NCT04347018.
- Registry record last updated 2024-10-04; status last verified 2024-09.
- Results first posted 2024-10-04.
- 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
NCT04347018 is a completed randomized, single-masked, parallel-group, single-center trial of BRIUS and a preadjusted edgewise full fixed appliance. Enrollment was 13, with 7 participants assigned to BRIUS and 6 to the comparator. The primary outcome was overall 3D tooth movement in millimeters at 18 weeks, summarized by medians and an interquartile-range framework.
The registry reports median movement values of 1.46 mm for BRIUS and 1.41 mm for the comparator. It does not report an estimable two-arm comparison for this endpoint. Interquartile-range values and comparative inferential results are not reported in the registry record. Serious adverse events, other adverse events and deaths are recorded as zero in both groups. Details of the analysis population, missing data, measurement procedures and statistical plan are not reported in the registry record.