Oral Pathology Asynchronous Telementoring Pilot Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Oral Pathology Asynchronous Telementoring Pilot Study (NCT04166214), a non-randomized na study. The primary outcome is Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening.

2. Clinical Question

3. Trial Design

This completed pilot study evaluates the feasibility and acceptability of integrating telementoring into oral-lesion identification at the 6 dental clinics of Family Health Centers at NYU Langone. The registry identifies the condition as oral cancer, classifies the allocation as non-randomized, records no masking, and describes the model as single-group. It lists imaging using intraoral cameras as the intervention.

The intervention description focuses on training dental faculty members and residents to use intraoral cameras, photograph oral lesions, and add the images and descriptions to the Dentrix electronic health record. Dental providers and dental patients appear as separate groups in the registry. They are not a like-for-like control comparison: providers deliver or report on the process, while the primary outcome is a patient-reported response after screening.

Enrollment is recorded as 51. The study began on 2020-07-14, reached primary completion on 2020-11-23, and has completed status. The registry record does not report a phase beyond the listed NA classification. It also does not report random assignment, a concurrent comparator, or masking; the record’s non-randomized, single-group description does not support a controlled treatment-effect interpretation.

The study’s stated purpose is to evaluate and enhance the feasibility and acceptability of integrating telementoring into oral-lesion identification. The listed secondary outcomes concern dental providers’ reports of successfully providing the intervention and of finding the process clear and straightforward. The primary patient outcome concerns perceived understanding of oral cancer screening. The registry record does not report a detailed protocol, a sample-size justification, or a statistical 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

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Dental Patients Who Strongly Agreed or Agreed That the Use of an Intra-Oral Camera By Their Dentists Helped Them to Better Understand Oral Cancer Screening, measured over At the end of the dental appointment, 30-45 minutes.

The primary endpoint is the percentage of dental patients who strongly agreed or agreed that use of an intraoral camera by their dentists helped them better understand oral cancer screening. The registry describes a Patient Exit Survey with 5 statements, completed at the end of the appointment after screening for oral cancer lesions using an intraoral camera. The endpoint uses responses to the second statement, which is scored on a Likert scale from 1 - Strongly Disagree to 5 - Strongly Agree. The stated timeframe is at the end of the dental appointment, 30-45 minutes.

This kind of patient-reported measure is used to capture participants’ views of the screening process, rather than a clinical diagnosis or a measure of whether lesions were identified correctly. Agreement with the statement can indicate that patients perceived the camera-assisted process as helpful to their understanding. It does not, by itself, establish objective knowledge change, diagnostic accuracy, or a clinical benefit.

The registry record does not report the number of patients who agreed or strongly agreed, the percentage, or the number with usable survey responses. Therefore, the endpoint’s observed value and its precision are not reported in the registry record. Its usefulness for assessing acceptability does not substitute for those missing outcome details.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What the endpoint represents. The primary outcome is a binary summary of a response scale: patients who selected Strongly Agree or Agree are counted as meeting the endpoint, and the outcome is expressed as a percentage of participants. This summary makes the question easy to describe, but it discards distinctions among the response options. For example, it does not retain the difference between agreement and strong agreement. The registry record does not report the underlying response distribution, so that detail cannot be assessed.

General: interpreting a percentage. A percentage is descriptive: it indicates the proportion of participants in the analyzed group who meet the stated response definition. Its meaning depends on the denominator. If some participants did not complete the survey or did not answer the relevant statement, the analyzed denominator may differ from enrollment. The registry record does not report the number of eligible patients, the number completing the survey, the number answering the statement, or how missing responses were handled. Consequently, the endpoint percentage cannot be reconstructed from the posted information.

General: uncertainty and confidence intervals. A confidence interval communicates statistical uncertainty around an estimate under a specified method and its assumptions. A narrow interval indicates greater precision for the estimate under those assumptions; a wide interval indicates less precision. An interval does not correct selection bias, measurement limitations, or a lack of a comparison group. No confidence interval or other uncertainty measure for the primary outcome is reported in the registry record, and no primary outcome estimate is reported.

What is and is not reported about analysis. The registry lists 4 outcome measures and records 0 analyses. It identifies the primary outcome as a percentage and describes the survey item and timeframe, but it does not report a statistical analysis plan, a model, a confidence-interval method, or an approach to missing data. The registry record also does not state whether analyses were adjusted for any participant or clinic characteristics. These details should not be inferred from the outcome description.

General: over-dispersion. Over-dispersion is relevant when observed variability is greater than a statistical model expects. If present, it can make standard errors too small and confidence intervals too narrow when a model fails to account for it. Whether over-dispersion is relevant depends on the data structure and analysis. The registry record does not report a model or analysis that would allow readers to assess it for this study.

Planning illustrations. Any sample-size planning illustration associated with the posted results is not the study’s own design justification and is not observed power. The described illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it considers an effect defined as a stated fraction of the observed effect. Those assumptions do not turn this non-randomized, single-group pilot into a two-arm comparison. The registry record does not report that these assumptions informed the study’s enrollment target, nor does it report a sample-size justification. Planning estimates are prospective illustrations under stated assumptions, not evidence that a study had a particular probability of detecting an effect.

General: design and causal interpretation. Randomization can help balance measured and unmeasured factors between comparison groups, while masking can reduce some forms of influence on assessment or reporting. This study is recorded as non-randomized, with no masking and a single-group model. Provider and patient groups have distinct roles rather than serving as comparable intervention and control groups. Thus, even a reported response percentage would be a description of responses in the study setting, not an isolated causal estimate of the intervention’s effect. The registry record does not report an alternative comparative analysis.

General: measurement. The patient outcome is a perception reported at the end of a dental appointment. Such a measure can be informative about acceptability and perceived understanding, but it is not interchangeable with a test of knowledge, a measure of lesion detection, or a clinical outcome. The registry record specifies the survey statement and response scale but does not report evidence about the scale’s validation or reliability in this study. Those properties should not be assumed.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Dental Patients")
n      <- c(39)
events <- c(37)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Dental Patients  39  37  94.9  82.7  99.4  83.1  98.6  83.1  98.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, including the primary patient-reported outcome and secondary outcomes about providers’ reports of successfully providing the intervention and finding the process clear and straightforward. It records 0 analyses. The registry record does not report how the outcomes were prioritized in analysis, whether additional outcomes were assessed, or whether any adjustment for multiple statistical tests was planned or used.

Multiplicity matters when several outcomes or analyses are tested: the chance of at least one apparently notable result can increase as the number of tests grows. General methods for addressing multiplicity include prespecifying a primary outcome, controlling an overall error rate, or describing analyses as exploratory. The record identifies a primary outcome, but does not report a multiplicity strategy. With no analysis results reported, it is not possible to determine what, if any, statistical adjustment would be relevant to the posted findings.

Missing-data handling is also not reported. The record does not give the number of survey responses available for the primary outcome, the number of unanswered items, or how incomplete responses were treated. It does not state whether the analysis included all enrolled participants, only those who completed the survey, or another defined population. These analysis-population details are not reported in the registry record.

These omissions matter because the denominator and handling of missing responses affect the interpretation of a percentage. They also constrain assessment of whether the reported participants represent everyone enrolled. The registry record provides enrollment and safety-group counts, but those figures do not identify the analysis population for the survey outcome. No missing-data assumptions or sensitivity analyses are reported.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The safety record lists dental providers and dental patients separately. For dental providers, 12 were recorded as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For dental patients, 39 were recorded as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. No top serious-event terms are listed.

These figures describe what was recorded in the registry. They do not establish that no adverse events occurred outside the information captured or reported there, and zero recorded events should not be read as proof that an intervention is risk-free. The registry record does not provide further detail about safety surveillance, event definitions, or the method used to collect adverse-event information.

The safety counts are not results for the primary patient-reported outcome. They also do not provide a comparison of safety between intervention and control groups, because the record describes a non-randomized, single-group study and does not identify a like-for-like control group. The provider and patient groups have different roles and should be read separately.

13. What the Result Does, and Does Not, Mean

The record establishes that this was a completed pilot focused on integrating intraoral-camera use and asynchronous telementoring into identification of oral lesions at Family Health Centers at NYU Langone. It describes a patient survey question about perceived understanding of oral cancer screening and provider outcomes concerning delivery and clarity of the process. These questions are relevant to evaluating feasibility and acceptability.

The posted information does not establish how patients answered the primary survey item or how providers rated the process. The primary result and secondary outcome results are not reported in the registry record. Therefore, the record does not show the observed percentage of patients who agreed or strongly agreed, the precision of that percentage, or whether the provider outcomes were favorable or unfavorable.

Even with outcome values, the design would matter. The non-randomized, single-group model and absence of masking do not provide a like-for-like control comparison. A descriptive percentage could characterize responses in this study setting, but could not by itself demonstrate that camera use or telementoring caused a change in understanding. The patient-reported endpoint is also a perception measure, not a direct test of knowledge, diagnostic performance, or clinical outcomes.

The registry’s enrollment and safety counts do not fill these gaps. Enrollment is recorded as 51, and safety groups are reported separately, but neither reveals the number of usable survey responses or the primary outcome value. Likewise, zero recorded adverse events describes the safety entries in the registry, not proof of no risk.

In practical statistical terms, the record describes what the study set out to examine and how it was framed, but does not report the results needed to judge the measured responses. It supports no conclusion about the magnitude, direction, or precision of the primary outcome.

14. Why This Trial Matters Statistically

This study matters statistically because it illustrates the distinction between a pilot’s implementation questions and a comparative treatment-effect question. Its stated purpose is to evaluate and enhance feasibility and acceptability of integrating telementoring into oral-lesion identification. The primary outcome asks patients about perceived understanding, while the secondary outcomes ask providers about providing the intervention and the clarity of the process. These are process and experience measures, not direct measures of diagnostic accuracy or clinical benefit.

The design classification is central to interpretation. The registry describes a non-randomized, single-group study with no masking. Provider and patient groups represent different roles in the project, not exchangeable comparison arms. This means the study structure is suited to descriptive evaluation of reported experiences, but the posted record does not identify a control comparison for estimating an intervention effect.

Another statistical lesson is that an endpoint definition is not an outcome result. The registry specifies the patient survey item, response scale, and timing, but does not report the response count or percentage. Without the result and its denominator, readers cannot assess the distribution of responses or the precision of the estimate. Clear measurement descriptions are useful, but they do not replace complete outcome reporting.

The record also highlights the importance of reporting analysis populations and missing-data methods for survey endpoints. Enrollment alone does not show how many people contributed data to a particular outcome. Here, those analysis details and the analysis plan are not reported in the registry record. Transparent reporting of such information would help readers evaluate representativeness and uncertainty.

15. 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 principal limitation of the posted record is that the primary outcome estimate is not reported. The record provides the outcome definition and survey timing, but no response count, percentage, or uncertainty interval. The secondary outcome results are also not reported, so the stated feasibility and acceptability aims cannot be assessed from outcome values in the registry record.

The design is non-randomized and single-group, with no masking and no like-for-like control comparison. This limits causal interpretation even if descriptive outcomes were available. The registry describes provider and patient groups with distinct roles; these groups should not be treated as comparable intervention and control arms. The record does not describe a comparative analysis.

The primary outcome is a patient’s report of perceived help with understanding oral cancer screening. It is not described as an objective knowledge assessment, diagnostic-accuracy measure, or clinical endpoint. The registry record does not report validation or reliability information for the survey measure in this study. The number of completed surveys and handling of unanswered items are also not reported, leaving the outcome denominator and missing-data approach unclear.

The record lists 4 outcome measures and 0 analyses but does not report the statistical analysis plan, a multiplicity approach, or analysis populations. It does not report a sample-size justification or state how enrollment was selected. Any planning illustration based on an observed effect should not be read as the study’s design rationale or as observed power.

Finally, the listed safety figures are limited to the recorded counts and do not include further detail about event ascertainment or definitions. These limitations apply to interpretation of the registry record; they do not establish what may have been reported elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Oral Pathology Asynchronous Telementoring Pilot Study — NCT04166214.
• Registry record last updated 2021-12-03; status last verified 2021-10.
• Results first posted 2021-12-03.
• 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.

19. Record Summary

The completed Oral Pathology Asynchronous Telementoring Pilot Study (NCT04166214), sponsored by NYU Langone Health, is recorded as a non-randomized, unmasked, single-group study. Enrollment is 51. The study began on 2020-07-14 and reached primary completion on 2020-11-23.

The intervention involves training dental faculty members and residents to use intraoral cameras, photograph oral lesions, and add images and descriptions to the Dentrix electronic health record. The primary outcome concerns the percentage of patients agreeing or strongly agreeing that camera use helped them better understand oral cancer screening. Provider-reported outcomes concern successful delivery and process clarity.

The registry record does not report the primary or secondary outcome results, the statistical analysis plan, missing-data handling, or analysis populations. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths for both the dental provider and dental patient groups.