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 Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain (NCT03944629), a randomized phase not stated study. The primary outcome is Change in Postoperative Facial Swelling From Baseline to Day 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03944629 |
| Phase | Phase not stated |
| Condition | Arnica, Third Molar Extraction |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tufts University |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes people undergoing extraction of partial or full/complete bony impacted third molars. The enrolled population’s eligibility details and baseline characteristics are not reported in the registry record. The registry lists enrollment of 53.
Intervention
The study group was assigned homeopathic Arnica montana, identified as SinEcch™, for perioperative management of swelling and pain. The dose, dosing schedule, and exact duration are not reported in the registry record.
Comparator
The control group was assigned a matching SinEcch™ placebo, described as a sugar pill. The allocation is listed as randomized, with double masking and a parallel-group model.
Primary question
The primary question concerns change in postoperative facial swelling from baseline to Day 3, measured using the 3dMD™ system. The registry does not report the group results or a numerical comparison, so the direction and size of any difference cannot be assessed from the record.
3. Trial Design
The registry record describes a randomized, double-blind, parallel-group controlled clinical trial sponsored by Tufts University. Its title concerns Arnica montana for postoperative edema and pain following third molar extraction. The record lists a start date of 2018-01-26, primary completion on 2022-06-14, and status as completed. Enrollment is listed as 53.
The two groups are described as the Study Group and Control Group. The Study Group was to receive homeopathic Arnica montana, identified as SinEcch™, for perioperative management of edema and pain. The Control Group was to receive a matching SinEcch™ placebo, described as a sugar pill. The registry identifies the allocation as randomized, masking as double, and model as parallel. Further details about the randomization procedure, masking roles, allocation concealment, and treatment administration are not reported in the registry record.
The primary outcome is change in postoperative facial swelling from baseline to Day 3. The record describes the measurement as postoperative facial swelling volume measured by the 3dMD™ system. Pain change from baseline to Day 3 and Day 5 is listed among the secondary outcomes. The registry lists five outcome measures overall, but does not report the full details needed to characterize all of them.
The record marks the trial completed but lists no outcome analyses. Its own sample-size justification, prespecified statistical analysis plan, interim analyses, and analysis populations are not reported in the registry record. Completion status alone does not supply results or establish how participants were analyzed.
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 | Study Group | Control Group |
|---|---|---|
| STARTED | 27 | 26 |
| COMPLETED | 26 | 24 |
| NOT COMPLETED | 1 | 2 |
Reasons for not completing this period:
| Reason | Study Group | Control Group |
|---|---|---|
| Withdrawal by Subject | 1 | 2 |
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 | Study Group | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 27 | 26 | 53 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 27 | 26 | 53 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 22.4 (18 to 28) | 23.5 (18 to 36) | 22.95 (18 to 36) |
| Sex: Female, Male: Female | Participants | 15 | 13 | 28 |
| Sex: Female, Male: Male | Participants | 12 | 13 | 25 |
| Race/Ethnicity, Customized: Asian | Participants | 9 | 6 | 15 |
| Race/Ethnicity, Customized: African American | Participants | 3 | 3 | 6 |
| Race/Ethnicity, Customized: White | Participants | 9 | 11 | 20 |
| Race/Ethnicity, Customized: Hispanic/Latino | Participants | 3 | 3 | 6 |
| Race/Ethnicity, Customized: Multi | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: Unknown | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 27 | 26 | 53 |
| BASELINE Postoperative Swelling: Right Side | Cm^2 | 40.6264 (SD 23.21150) | 45.9915 (SD 27.64742) | 43.30895 (SD 2.68255) |
| BASELINE Postoperative Swelling: Left Side | Cm^2 | 40.589 (SD 23.28939) | 45.0376 (SD 23.79449) | 42.8133 (SD 2.2243) |
| BASELINE PAIN | units on a scale | 0.4259 (SD 1.53788) | 0.2712 (SD 0.80302) | 0.34855 (SD 0.07735) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Postoperative Facial Swelling From Baseline to Day 3, measured over Baseline and Day 3.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | cm^2 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in postoperative facial swelling from baseline to Day 3, with the measure described as facial swelling volume assessed using the 3dMD™ system. The registry lists the unit as cm^2 and identifies the outcome as a mean with standard deviation. The record does not explain the measurement procedure, how the change was calculated, or how missing measurements were handled.
In general, measuring change compares a participant’s later measurement with that participant’s baseline measurement. A group mean change can describe the average direction and size of change in that group. For a randomized comparison, the difference between groups’ mean changes can address whether the groups had different average changes over the measured period. That interpretation depends on the analysis actually used and the completeness and quality of the measurements.
Facial swelling is relevant to the study’s stated focus on postoperative edema. A quantified measure can make a physical outcome more systematically comparable than an unstructured description; this is a general measurement principle, not a claim about the performance of the 3dMD™ system in this trial. The registry does not report the primary endpoint values, variability, or a between-group estimate. Therefore, neither the magnitude nor the precision of the observed group comparison can be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a primary endpoint and a completed trial, but it does not report numerical primary outcome results. In particular, the record does not provide the group means, standard deviations, changes from baseline, between-group estimate, confidence interval, or p-value for facial swelling at Day 3. The primary outcome comparison therefore cannot be interpreted for direction, magnitude, or statistical precision from the registry record.
The record lists pain change from baseline to Day 3 and Day 5 as secondary outcomes. Their results are not reported in the registry record either. The record lists five outcome measures and zero analyses. It also indicates that the primary outcome was not reduced to one comparison because it has several categories or time points. Consequently, there is no single posted primary contrast to evaluate and no basis for describing a treatment effect from the registry information.
In general, an estimated difference describes the observed separation between groups on an outcome, while a confidence interval describes the uncertainty around that estimate under the assumptions of the analysis. A p-value addresses compatibility between the observed data and a specified null model; it does not describe the size or clinical importance of a difference. These concepts require actual estimates and analysis results. None are reported for the primary outcome in the registry record.
Enrollment is listed as 53, and the safety record gives denominators of 27 in the Study Group and 26 in the Control Group. Those denominators do not establish how many participants contributed measurements to the primary endpoint or whether all enrolled participants were randomized, treated, or included in an outcome analysis. The analysis population and the handling of missing measurements are not reported in the registry record.
Safety entries show zero serious adverse events and zero deaths in each listed group. The record also reports zero other adverse events in each group. These are registry counts, not evidence that no events occurred outside the recorded categories or observation period. The duration and completeness of safety collection are not reported in the registry record.
Overall, the registry supports a description of the planned randomized comparison and the recorded safety counts, but not a conclusion about the primary outcome. The absence of posted outcome estimates is not evidence of no difference; it means the direction and precision of the comparison cannot be determined from this record.
9. Statistical Methods Explained
The registry classifies the primary outcome as a continuous measure summarized by a mean and standard deviation. In general, a mean describes the average value in a group, while a standard deviation describes how spread out participant measurements are around that mean. The two statistics answer different questions: the mean characterizes the group’s central value, and the standard deviation characterizes variation among individual measurements. Neither is reported for the primary endpoint in the registry record.
Because the endpoint is described as change from baseline, an analysis could summarize each participant’s change and then compare average changes between groups. In general, a between-group comparison is more informative about the randomized treatment contrast than considering change within one group alone. Within-group change can reflect the passage of time, the procedure, or other influences, and does not by itself isolate the effect of group assignment. The registry does not report the analysis method used for this endpoint, so this general explanation should not be read as a description of the trial’s actual analysis.
A confidence interval, in general, gives a range of values compatible with the observed data under the specified statistical method and its assumptions. Its width conveys precision: a narrower interval indicates less statistical uncertainty than a wider one, all else equal. A confidence interval can include values corresponding to different directions or magnitudes of effect, so interpretation requires examining the estimate and interval together. No confidence interval or estimate for the facial-swelling comparison is reported in the registry record.
A p-value, in general, measures how unusual the data would be under a specified null hypothesis and analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of a difference. Without a reported p-value, estimate, and uncertainty interval, statistical evidence for the primary comparison cannot be characterized. The registry lists zero analyses, so no analysis result is available to interpret.
Several outcome measures can create multiplicity concerns. In general, when researchers assess multiple outcomes, time points, or contrasts, the chance of at least one apparently notable result can increase if the testing strategy is not considered in advance. A prespecified primary endpoint and analysis can help readers distinguish the main question from secondary or exploratory analyses. This record identifies a primary endpoint and lists pain outcomes at Day 3 and Day 5, but the statistical plan and any multiplicity strategy are not reported. The registry also notes that the primary outcome has several categories or time points and was not reduced to one comparison.
Over-dispersion is a general issue for some count outcomes when variability exceeds what a simple model assumes. The primary endpoint is described as a continuous measure summarized by a mean and standard deviation, so over-dispersion is not the central issue identified by the registry. More generally, statistical methods should reflect the outcome’s scale and distribution; the actual modeling choices for the trial are not reported.
The registry includes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. These are planning calculations, not observed power and not evidence that the trial was designed using those assumptions. The stated effect to detect is a selected portion of the observed effect. The trial’s own sample-size justification and the numerical planning outputs are not reported in the registry record. A planning illustration cannot substitute for a reported outcome estimate or establish that an analysis was adequately powered.
In general, an analysis population specifies which participants contribute to an estimate, such as all randomized participants or only those with observed outcome data. Different populations can yield different answers, particularly when some measurements are missing or treatment adherence varies. The registry does not report the analysis population, participant flow, or handling of missing data. It is therefore not possible to determine from the record whether the listed enrollment corresponds to the population analyzed for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including the primary facial-swelling outcome and secondary pain changes from baseline to Day 3 and Day 5. It reports zero analyses. The record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No multiplicity adjustment or strategy for prioritizing outcome tests is reported in the registry record.
In general, multiplicity matters when several outcomes, time points, or comparisons are assessed. If many tests are considered, an apparently unusual result can arise by chance more often than with a single prespecified test. Interpretation therefore depends on knowing which outcomes and comparisons were planned, how they were prioritized, and whether any adjustment was used. Those details are not reported in the registry record, and no numerical outcome results are available to assess.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not state how many participants had baseline and Day 3 swelling measurements, whether participants withdrew, or how any unavailable measurements were treated. The listed enrollment and adverse-event denominators do not establish the number included in an outcome analysis. In general, missingness can affect an estimate when participants with unavailable measurements differ from those with observed measurements; the extent and direction of any such effect cannot be assessed without participant-flow and analysis details.
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 |
|---|---|---|---|
| Study Group | 0 | 27 | 0.0% |
| Control Group | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Study Group | 0 of 27 |
| Control Group | 0 of 26 |
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 |
|---|---|
| Study Group | 0 of 27 |
| Control Group | 0 of 26 |
The safety record lists 27 participants at risk in the Study Group and 26 in the Control Group. It records zero serious adverse events in each group, zero other adverse events in each group, and zero deaths in each group. These are the counts recorded for the listed denominators.
In general, zero recorded events in a group does not establish that the intervention has no risk. It describes the registry’s event count within the recorded observation and reporting framework. The record does not report the safety collection period, event definitions beyond the serious and other categories, completeness of follow-up, or whether any participants were excluded from safety monitoring. The denominators are safety-record denominators and do not establish the number included in the primary outcome analysis.
The entries should therefore be read narrowly: no serious adverse events, other adverse events, or deaths are recorded for either listed group. They do not resolve the trial’s primary facial-swelling question, and they do not characterize unrecorded events or risks beyond the registry information.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was listed as a completed randomized, double-blind, parallel-group trial comparing perioperative homeopathic Arnica montana with a matching placebo around third molar extraction. It identifies change in postoperative facial swelling from baseline to Day 3 as the primary outcome and lists pain changes at Day 3 and Day 5 as secondary outcomes. It also records safety counts for the two groups.
The record does not report primary or secondary outcome estimates, group variability, confidence intervals, p-values, or analyses. As a result, it does not show whether the groups differed in facial swelling or pain, how large any difference was, or how precisely it was estimated. A completed status is not itself an outcome result. Likewise, the absence of a reported estimate should not be interpreted as evidence that the groups were the same.
The zero adverse-event counts are limited to the entries in the registry. They do not prove absence of risk, establish complete follow-up, or answer the efficacy question. The record also does not describe the analysis population or missing-data handling, which limits assessment of how representative any eventual outcome analysis would be.
In general, a clinical-trial interpretation requires the outcome estimate, its uncertainty, and enough information about the analysis to understand what participants and measurements contributed. Here, the registry information supports a description of the trial’s design and recorded event counts, but not a conclusion about the treatment comparison. The trial’s own statistical analysis plan and sample-size justification are not reported in the registry record.
13. Why This Trial Matters Statistically
This record illustrates an important distinction between trial status and availability of results. A study can be listed as completed while the registry record still lacks outcome estimates and statistical analyses. Without those results, readers cannot assess the size, direction, or precision of the primary comparison, regardless of the stated design.
The trial’s randomized, double-blind, parallel-group structure identifies the intended basis for comparing Arnica montana with a matching placebo. But design labels alone do not reveal whether the outcome data support a difference, how uncertain that difference is, or how missing measurements and multiple outcomes were handled. Those details are essential for statistical interpretation and are not reported in the registry record.
The record also shows why a named primary endpoint is not enough for a full results interpretation. The endpoint is described as change in facial swelling from baseline to Day 3, yet the registry notes several categories or time points and supplies no single comparison. It lists five outcome measures and zero analyses. Readers therefore cannot connect the stated question to a reported estimate.
Finally, the safety counts and enrollment information answer different questions. The event counts describe what the registry records for each safety denominator; they do not substitute for the unreported primary outcome analysis. Keeping these distinctions clear prevents design details, completion status, and zero recorded events from being mistaken for evidence about the size or certainty of an efficacy comparison.
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 central limitation for interpretation is that the registry record does not report numerical results for the primary endpoint or the listed pain outcomes. It provides no group summaries, between-group estimate, confidence interval, or p-value. The direction, magnitude, and precision of the outcome comparison therefore cannot be assessed.
The primary outcome is described as change from baseline to Day 3 and as facial swelling volume measured using the 3dMD™ system, with the unit listed as cm^2. Measurement procedures, assessor roles, and details of the change calculation are not reported in the registry record. The registry also notes several categories or time points and does not reduce the outcome to one comparison.
The registry lists five outcome measures but provides no analyses. The statistical analysis plan, the primary contrast, any multiplicity approach, and the trial’s own sample-size justification are not reported. The sample-size illustrations use stated planning assumptions, but they cannot establish observed power or explain the trial’s design rationale.
Participant flow, baseline characteristics, analysis populations, missing outcome data, treatment adherence, and the handling of unavailable measurements are not reported in the registry record. Safety-event follow-up and collection details are also absent. These gaps restrict assessment of how complete and representative the outcome and safety records are. The record’s completed status does not resolve these limitations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of Arnica Montana in Reducing Postoperative Edema and Pain — NCT03944629.
- Registry record last updated 2026-01-29; status last verified 2026-01.
- Results first posted 2026-01-29.
- 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
NCT03944629 is a completed randomized, double-blind, parallel-group trial sponsored by Tufts University. The registry lists enrollment of 53, a start date of 2018-01-26, and primary completion on 2022-06-14. The study compared perioperative homeopathic Arnica montana, identified as SinEcch™, with matching SinEcch™ placebo for people undergoing third molar extraction.
The primary outcome was change in postoperative facial swelling from baseline to Day 3, measured using the 3dMD™ system. Pain changes from baseline to Day 3 and Day 5 were listed as secondary outcomes. The registry reports no outcome analyses or numerical efficacy results. Safety entries record zero serious adverse events, zero other adverse events, and zero deaths in the Study Group and Control Group.