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 Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment (NCT01658059), a randomized na study. The primary outcome is Reducing Children's Anxiety.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01658059 |
| Phase | NA |
| Condition | Children's Dental Anxiety |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Triple |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hadassah Medical Organization |
| Results posted | Yes |
2. Clinical Question
Population
Children described in the study summary as healthy and aged 5-12 years, with children's dental anxiety listed as the condition. The registry’s recorded enrollment is 22. The summary describes a planned group of thirty children, so the narrative and recorded enrollment do not match. Eligibility criteria beyond the summary’s description are not reported in the registry record.
Intervention
A homeopathic remedy given before dental treatment. The registry classifies it as an intervention of type “other”; the remedy’s name, preparation, dose, and administration details are not reported in the registry record.
Comparator
Placebo before dental treatment. The trial is recorded as a randomized crossover, with one group receiving the remedy first and placebo second, and the other group receiving placebo first and the remedy second. Details about the timing between treatment periods are not reported in the registry record.
Primary question
The primary outcome description concerns salivary cortisol and salivary α-amylase before and after dental treatment. The study aim is to explore whether the remedy reduces children’s dental anxiety and facilitates dental treatment. The registry record does not post outcome values or an analysis comparing the remedy with placebo, so it does not establish what the trial found about these questions.
3. Trial Design
NCT01658059 is recorded as a randomized, triple-masked crossover trial. Its listed interventions are a homeopathic remedy and placebo. The group descriptions specify opposite treatment sequences: one group received the remedy first and placebo second, while the other received placebo first and the remedy second. This sequence structure is consistent with a crossover design, in which participants can receive both study conditions in different periods. The record does not explain the period schedule, interval between treatments, or whether any washout period was used.
The recorded enrollment is 22, and the status is completed. The study start is recorded as 2012-09 and primary completion as 2014-12. The phase is recorded as NA. The study summary describes a prospective, double-blind study and says thirty healthy children aged 5-12 years would receive remedy or placebo. The registry’s design field instead records triple masking, and the narrative enrollment description differs from the recorded enrollment. The record does not explain these differences.
The summary describes measurements of salivary cortisol, salivary α-amylase, the facial image scale, and the Houpt behavior scale. The primary outcome entry specifically describes saliva cortisol and α-amylase levels before and after dental treatment, with a timeframe of each dental appointment, approximately 30 minutes on average. The registry record lists one outcome measure but no analyses. It does not report the allocation process, masking roles, treatment doses, eligibility criteria in full, or the statistical analysis plan. Consequently, the design can be described from the recorded sequence and masking labels, but important operational details cannot be established from the 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.
First Intervention- 2 Days
| Stage | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| STARTED | 12 | 10 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 6 | 5 |
Washout Period- 14 Days
| Stage | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| STARTED | 6 | 5 |
| COMPLETED | 6 | 5 |
| NOT COMPLETED | 0 | 0 |
Second Intervention- 2 Days
| Stage | Homeopathic Remedy First, Then Placebo | Placebo First, Then Homeopathic Remedy |
|---|---|---|
| STARTED | 6 | 5 |
| COMPLETED | 6 | 5 |
| 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 | All Study Population |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 7.09 (5 to 9) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 4 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Israel | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Reducing Children's Anxiety, measured over Each dental apointment, aproximatly 30 minutes on the average.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/ml |
| Endpoint classification | Continuous Endpoint |
The primary outcome entry is titled “Reducing Children's Anxiety” and describes measuring salivary cortisol and salivary α-amylase before and after dental treatment. The unit is ng/ml, the summary measure is a mean, and dispersion is specified as standard deviation. The timeframe is each dental appointment, approximately 30 minutes on average. These are biological measurements recorded around treatment, and the study summary identifies them as measures of anxiety reduction.
In general, a mean describes the average value of a continuous measurement, while a standard deviation describes how spread out individual measurements are around that average. Comparing measurements before and after treatment, or between remedy and placebo conditions, could help characterize changes in these biomarkers. The registry does not specify which contrast was designated for the primary statistical test, how the two biomarkers were to be handled together, or whether change scores or another approach were planned.
The study summary also names the facial image scale and Houpt behavior scale as measures. Those instruments are not included in the primary outcome description. No numerical endpoint results, variability estimates, confidence intervals, or test statistics are posted. The endpoint definition therefore describes what the study intended to measure, but the available record does not show the observed measurements or their estimated treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes a randomized, triple-masked crossover comparison of a homeopathic remedy and placebo before dental treatment. It also identifies salivary cortisol and α-amylase as the primary outcome measures. However, it contains no posted outcome analysis: the analysis count is zero, and the primary outcome is flagged as having several categories or time points that were not reduced to one comparison. There are no posted group means, standard deviations, treatment contrasts, confidence intervals, or p-values to interpret.
As a result, the record does not show the direction or size of any difference between remedy and placebo. It also does not show whether measurements changed from before to after treatment, whether results differed across the two treatment sequences, or how variable the measurements were. The study summary’s expected result—that the remedy would reduce anxiety and increase cooperation—is a statement of expectation, not a reported finding. It should not be read as evidence that the expected result occurred.
In general, a confidence interval communicates the range of effects that are reasonably compatible with the data and the analysis assumptions. A narrow interval would indicate greater precision than a wide interval. Because no interval is posted, the precision of any treatment comparison cannot be assessed. Likewise, a p-value, if reported, would address compatibility with a specified null model; it would not by itself describe the size, clinical importance, or precision of an effect. No such test result is available in the registry record.
The crossover structure may permit comparisons within participants, which can account for stable differences between people when the analysis is designed appropriately. But crossover interpretation depends on the period structure, treatment sequence, and assumptions about effects carrying from one period into another. The record does not report the planned handling of period or sequence effects, or whether carryover was assessed. It is therefore not possible to tell how those design features were addressed.
The posted enrollment is 22, while the summary describes thirty children as the planned study group. The record does not explain that discrepancy or report whether enrollment affected the precision of the outcome estimates. There are no results from which to judge precision in any case. The completed status indicates that the study is recorded as completed; it does not substitute for outcome data or establish the result of the comparison.
9. Statistical Methods Explained
Randomization and treatment sequence. The registry labels allocation as randomized and the model as crossover. The group descriptions specify remedy followed by placebo for one sequence, and placebo followed by remedy for the other. Randomization is generally used to reduce systematic differences in treatment assignment. In a crossover trial, sequence assignment also determines the order in which participants receive conditions. The method used to generate or conceal the assignment is not reported in the registry record.
Masking. The design field records triple masking. Masking is generally intended to reduce the influence of treatment knowledge on participants, care providers, or outcome assessment, depending on who is masked. The registry record does not identify which roles were masked or describe how masking was maintained. The study summary calls the study double-blind, which differs from the triple-masking label in the design field; the record does not explain this difference.
Crossover comparisons. In general, a crossover design exposes participants to more than one condition in different periods. When the same participant contributes measurements under both conditions, a paired comparison can account for stable participant-level characteristics. This can be useful when outcomes vary considerably between people. It does not eliminate the need to account for time, period, sequence, or possible carryover effects. Carryover means an effect of an earlier treatment may persist into a later period. The registry record does not describe a washout interval or state how paired measurements, period effects, sequence effects, or carryover were to be handled in the analysis.
Continuous outcomes and summaries. The primary outcome is described as a mean with standard deviation, in ng/ml. A mean is a measure of location for continuous data; a standard deviation describes the spread of measurements around that mean. These summaries can help readers understand typical values and variability, but they do not alone quantify a treatment contrast or its uncertainty. The registry record does not post means, standard deviations, or a model for comparing the conditions. It also does not clarify whether the primary comparison was intended to use post-treatment values, changes from before treatment, or another summary.
Uncertainty and tests. In general, an estimated treatment contrast is more informative when accompanied by an uncertainty interval. A confidence interval describes the precision of an estimate under the chosen model and its assumptions. A hypothesis test can assess whether the observed data are compatible with a null hypothesis, but a test result alone does not convey the magnitude or practical relevance of a difference. No contrast estimate, confidence interval, or p-value is reported in the registry record. The statistical analysis plan, including the test or model and its assumptions, is also not reported in the registry record.
Distribution and model assumptions. General statistical methods for continuous outcomes may rely on assumptions about the distribution of measurements or model residuals. If observations are more variable than a model allows, uncertainty estimates and tests may be unreliable; methods that account for over-dispersion can be relevant when that feature is present. The record does not report the observed distributions, any assessment of model assumptions, or a selected method. There is no basis in the posted information to say whether over-dispersion was present or relevant to this trial.
Planning calculations. The record describes sample-size illustrations as planning exercises based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the stated effect to detect is a fraction of the observed effect. These are described as planning illustrations, not as the trial’s own design justification. No sample-size justification or power calculation for the trial is reported in the registry record. The posted outcome information does not give an observed effect estimate, so the illustrations cannot be treated as evidence of the trial’s precision or as observed power. In general, planning calculations depend on assumptions about the effect, variability, design, and analysis; they do not establish what a completed trial found.
Analysis availability. The registry lists one outcome measure and zero analyses. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Thus, there is no sponsor analysis in the registry record to compare with a recalculation, and no numerical recalculation can be interpreted from the available outcome information. The record does not report whether analyses were conducted elsewhere or whether additional results were posted outside the registry entry.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes salivary cortisol and salivary α-amylase, measured before and after dental treatment. The study summary additionally names the facial image scale and Houpt behavior scale. Multiple measures, time points, or treatment contrasts can create a multiplicity issue: when many statistical tests are considered, the chance of at least one apparently notable result can increase. In general, a prespecified analysis plan can identify primary comparisons and explain whether any adjustment or hierarchy is used. Such a plan, including any multiplicity strategy, is not reported in the registry record.
The record lists one outcome measure but zero analyses and notes that the primary outcome has several categories or time points that were not reduced to one comparison. It therefore does not identify a single reported estimate or test for the primary question. No adjustment method, outcome hierarchy, or distinction between confirmatory and exploratory analyses is reported in the registry record.
Missing-data information is also absent. The registry record does not report the amount or pattern of missing measurements, reasons for missingness, or the method used to handle incomplete observations. It does not report an analysis population, such as whether the analysis followed assigned sequence or included only participants with measurements under both conditions. These omissions matter in a crossover design because the intended within-participant comparison depends on having usable measurements across treatment periods. Without the analysis details and missingness information, the potential impact of incomplete data cannot be evaluated.
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 |
|---|---|---|---|
| Homeopathic Remedy | 0 | 11 | 0.0% |
| Placebo | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Homeopathic Remedy | 0 of 11 |
| Placebo | 0 of 11 |
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 |
|---|---|
| Homeopathic Remedy | 0 of 11 |
| Placebo | 0 of 11 |
The adverse-event entry reports, for the Homeopathic Remedy group, 11 participants at risk for serious events and zero serious events; it also reports 11 at risk for other events and zero other events. For the Placebo group, it reports 11 participants at risk for serious events and zero serious events, and 11 at risk for other events and zero other events. No serious adverse-event terms are listed.
These are the registry’s recorded figures for the listed groups and categories. Zero reported events means none are recorded in those entries; it does not establish that the possibility of harm is absent. The record does not provide event descriptions, follow-up details, severity grading for other events, or an explanation of how adverse events were collected. It also does not describe how participants who received both conditions in the crossover were handled in the safety summaries. The figures should therefore be read as a limited registry report, not as a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
The available record documents the design and intended measurements of a randomized, triple-masked crossover trial comparing a homeopathic remedy with placebo before dental treatment. It identifies salivary cortisol and α-amylase as the primary outcome measures and records a completed study. Those details describe the trial’s setup, not its efficacy findings.
No outcome values or statistical comparisons are posted. Consequently, the record cannot establish whether the remedy condition was associated with higher or lower measurements than placebo, how large any difference was, or how precisely it was estimated. It also cannot establish whether the before-and-after measurements changed or whether the behavior and facial scales described in the summary supported any particular interpretation. The expected result in the study summary remains an expectation rather than a result.
General statistical interpretation requires looking at effect estimates and uncertainty, as well as the design and analysis assumptions. Here, no estimates or uncertainty intervals are available. The crossover design could support within-participant comparisons in principle, but the record does not explain the analysis of periods, sequences, or possible carryover. The planned comparison and analysis population are also not reported. These gaps prevent readers from judging whether the posted design was translated into an appropriate analysis.
The registry’s adverse-event entries record zero events in the listed serious and other event categories for both groups. That is useful as a description of those entries, but it does not answer the efficacy question and does not by itself rule out safety concerns. The registry does not describe event-collection methods or provide additional detail about follow-up.
Overall, this registry entry provides a limited account of trial design, intended outcomes, and recorded adverse-event counts, but not the outcome evidence needed to assess the primary comparison. Neither a positive nor a negative treatment conclusion can be drawn from the absence of posted outcome analyses.
13. Why This Trial Matters Statistically
This trial is statistically notable for its crossover structure. In general, crossover designs can make comparisons within participants, reducing the influence of stable differences between individuals. They also require careful attention to treatment order, period effects, and possible carryover. The registry identifies opposing treatment sequences but does not report the analysis methods or timing details needed to assess how those features were addressed.
The outcome description also illustrates why a registered endpoint needs a clear analysis target. It names two salivary biomarkers and measurements before and after treatment, while the study summary names additional behavioral and facial measures. The record does not state which specific contrast was the primary test or how multiple measures and time points were prioritized. Without this information, the primary question cannot be connected to a single posted estimate.
The enrollment narrative and recorded enrollment differ: the summary says thirty children were to receive treatment, while the enrollment field records 22. The record does not explain the discrepancy. It also provides no outcome estimates from which to assess statistical precision. This makes it important to distinguish a completed status from a complete report of results.
Finally, the entry shows how safety counts and efficacy results answer different questions. The adverse-event fields contain zero counts in the listed categories, but the registry contains no efficacy analysis. A reader needs both a clearly specified design and transparent outcome reporting to evaluate what a trial contributes. In this record, the design features are partly described, while the primary statistical findings are unavailable.
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 registry entry restrict interpretation. Most importantly, no primary outcome values or analyses are posted. The registry identifies the salivary measures and their general timing, but does not show treatment contrasts, variability, or uncertainty. The analysis count is zero, and the outcome is noted as involving several categories or time points that were not reduced to one comparison.
The design details are incomplete for evaluating a crossover analysis. The record lists treatment sequences but does not report period timing, a washout interval, assessment of carryover, or the planned handling of sequence and period effects. It also does not describe the randomization method or identify the roles covered by triple masking. The study summary’s double-blind description differs from the triple-masking field, without an explanation.
The summary describes thirty healthy children aged 5-12 years, while the recorded enrollment is 22. The registry does not explain whether the narrative refers to a target or another stage of the study. Eligibility criteria beyond the brief description, participant flow, withdrawals, and reasons for missing measurements are not reported in the registry record.
The primary outcome entry focuses on cortisol and α-amylase, whereas the summary also mentions the facial image scale and Houpt behavior scale. The record does not explain the status or analysis of those additional measures. A statistical analysis plan, missing-data approach, analysis population, and multiplicity strategy are not reported. These gaps mean that neither the robustness of the intended comparison nor the relationship between all planned measures can be evaluated from the registry entry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment — NCT01658059.
- Registry record last updated 2019-03-20; status last verified 2019-03.
- Results first posted 2019-03-11.
- 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
NCT01658059 is a completed, randomized, triple-masked crossover trial sponsored by Hadassah Medical Organization. It compares a homeopathic remedy with placebo before dental treatment, with the two recorded groups receiving the conditions in opposite sequences. The study start is recorded as 2012-09 and primary completion as 2014-12; phase is listed as NA.
The primary outcome description concerns salivary cortisol and α-amylase, measured before and after dental treatment, with mean and standard deviation specified. The study summary also mentions the facial image scale and Houpt behavior scale. Recorded enrollment is 22, while the summary describes thirty children aged 5-12 years. The registry record contains no posted outcome analyses or numerical efficacy results. Its adverse-event entries list zero serious and zero other events in the reported groups, with no serious-event terms listed.