A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces. (NCT06688474), a registered phase not stated study. The primary outcome is Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench).

2. Clinical Question

3. Trial Design

The registry describes a single-cohort device study, not a randomized treatment trial. The listed Bruxism Cohort consists of 2 male participants with diagnosed bruxism who were to wear the sensor-enhanced night guard during sleep. No separate comparator arm or allocation procedure is reported. The record therefore does not support a between-group estimate of a treatment effect.

The intended device-wear period was 21 days, with a 6+ hour sleep period each night. The primary outcome timeframe is described as the mean of nocturnal measurements across up to 21 nights of sensor wear. The record says force was sampled at 4 Hz during overnight wear and summarized per participant as mean nocturnal clenching force. These are descriptions of the planned measurement approach; they do not establish how much data were ultimately collected or whether all participants completed the intended wear period.

The study started on 2024-08-05, and the recorded primary completion date is 2024-10-18. Its status is TERMINATED. The reason for termination, whether any participant completed the planned device wear, and the timing or circumstances of termination are not reported in the registry record.

The record lists one primary outcome measure and no analyses. It does not report a statistical analysis plan, an outcome result, or a sample-size justification. The information describes a feasibility-oriented question about miniaturized hardware and force-profile capture, but does not establish that the device met those aims. Without reported outcome data, the study design can be described, but the performance of the sensor cannot be assessed statistically.

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 Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench), measured over Mean of nocturnal measurements across up to 21 nights of sensor wear.

The primary endpoint is mean nocturnal clenching force, expressed as a percentage of each participant’s maximum voluntary clenching force established during calibration. The sensor-enhanced mouth guard was intended to measure force during overnight wear, with samples taken at 4 Hz. Measurements were to be summarized for each participant as a mean, over the timeframe described as the mean of nocturnal measurements across up to 21 nights of sensor wear.

Expressing force relative to an individual calibration value puts the nocturnal measurement on a participant-specific scale rather than reporting only an absolute force. A mean is a summary of the recorded values; it can describe the typical level across the measurements included in its calculation, but it does not show the full pattern of force peaks, timing, or night-to-night variability. The study description separately refers to capturing bite compression force profiles, but the registry lists the mean as its primary outcome measure.

This endpoint is relevant to the stated technical objective because it represents the type of force quantity the device was designed to record. However, an endpoint definition is not an endpoint result. The registry record does not report the mean clenching force, its standard deviation, the number of usable measurements, or the number of nights contributing data. It is therefore not possible to judge the observed force level or the completeness and consistency of measurement from the endpoint description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measurement: mean nocturnal clenching force expressed relative to each participant’s maximum voluntary clenching force. A continuous outcome can take many values on a measurement scale, unlike a binary outcome that records whether an event occurred. The endpoint description says the force was sampled at 4 Hz and summarized per participant as a mean. The registry names standard deviation as the dispersion measure, but does not post the endpoint’s numerical mean or standard deviation.

What does a mean summarize?

A mean combines observed measurements into one central summary. In this study, the stated summary is the participant-level mean of nocturnal measurements across up to 21 nights of sensor wear. Such a summary can make a large set of readings easier to describe, but it suppresses details about how readings vary over time. Distinct patterns of force may produce the same mean. The record’s broader interest in force profiles is therefore not identical to the primary endpoint, which is a mean.

Interpretation of a mean depends on knowing what observations contributed to it. The registry describes the intended measurement frequency and timeframe, but does not report the actual number of readings, nights, or valid sensor recordings. It also does not report how calibration values were obtained beyond saying that maximum voluntary clenching force was established during calibration. These omissions prevent a reader from assessing the completeness of the endpoint calculation.

Why is a standard deviation relevant?

Standard deviation describes the spread of measurements around a mean. In general, a larger standard deviation indicates greater variability among the observations included in the calculation, while a smaller one indicates that observations are more closely grouped. It is not an estimate of the precision of the mean by itself; precision also depends on the amount and structure of data. Here, the endpoint lists standard deviation as its dispersion measure, but the registry record reports no value. No conclusion about variability can therefore be drawn.

What would a confidence interval add?

In general, a confidence interval describes statistical uncertainty around an estimate under a specified method and assumptions. It helps distinguish the estimate’s central value from the range of values that remain compatible with the data and method. The registry record does not report a confidence interval or an analysis from which one can be interpreted. Without a numerical estimate and an interval, the precision of the primary endpoint is unknown.

Why does study design affect interpretation?

A comparator allows a study to assess how outcomes differ between groups, subject to its design and analysis. This record describes one cohort and no separate control group. A single cohort can still provide descriptive observations about device measurements, but it cannot furnish a randomized between-group contrast. The record does not state an allocation procedure and does not describe the study as a randomized comparison. Any interpretation should remain focused on the measurement objective rather than a comparative treatment effect.

The cohort size also matters for how broadly descriptive observations could be generalized. The registry lists 2 male participants. That is the planned enrollment figure in the record, not confirmation that two participants completed the study or contributed usable measurements. Actual analyzed numbers are not reported. The record also does not describe an inferential model, covariate adjustment, repeated-measures approach, or treatment of within-participant correlation. These details are not reported in the registry record and should not be inferred from the endpoint definition.

What is over-dispersion in general?

Over-dispersion is a concern for some statistical models when observed variability is greater than the model assumes. It can make uncertainty estimates too small if ignored. Its relevance depends on the outcome distribution and analysis model. The registry record reports a continuous mean endpoint and no statistical analysis, so it does not establish that over-dispersion was assessed or that a particular model was used. General discussion of over-dispersion cannot substitute for a trial-specific analysis description.

How should planning calculations be read?

In general, sample-size planning illustrations describe the number of participants that might be needed to detect a specified effect under stated assumptions. They depend on assumptions such as the significance level, allocation, outcome variability, and effect size. A planning illustration is not a study result and is not observed power. The record states that its planning illustration is based on an observed effect, but no observed endpoint effect or analysis is reported. Consequently, a trial-specific observed effect cannot be evaluated from the registry entry, and the planning illustration should not be read as evidence that the study had a particular ability to detect a real effect. The registry record does not report the study’s own sample-size justification.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Bruxism Cohort")
n   <- c(2)
m   <- c(0.87)
sp  <- c(4.81)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Bruxism Cohort  2  0.870  4.810  -42.346  44.086

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and no analyses. It does not report a statistical analysis plan, testing hierarchy, or procedure for controlling multiplicity. Multiplicity arises when several outcomes or hypotheses are tested: the more tests considered, the greater the opportunity for a chance finding if results are interpreted without an appropriate plan. With no reported analysis and only one listed primary outcome measure, the extent of any testing cannot be determined. Other exploratory measurements or analyses are not reported in the registry record.

Missing-data handling is also not reported. The outcome timeframe allows for measurements across up to 21 nights, but the record does not state how many nights were completed, whether any readings were invalid or absent, or how a participant’s mean would be calculated if some nights lacked usable data. It does not describe imputation, exclusion rules, or sensitivity analyses. These details matter because a mean based on an incomplete set of recordings may not represent the same measurement experience as a mean based on the intended wear period.

The analysis population is not specified. The enrollment figure is 2, but the registry does not state how many participants were included in an endpoint analysis or whether any participant withdrew or lacked usable measurements. The reason for the TERMINATED status is likewise not reported in the registry record. Without analysis-population definitions and missing-data details, the completeness and representativeness of any potential result cannot be assessed. No assumptions about the handling of incomplete data or the number analyzed should be made.

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 5% reporting threshold.

The adverse-event record lists the Bruxism Cohort with 2 participants at risk for serious adverse events and 0 participants affected. It also lists 2 participants at risk for other adverse events and 0 affected, with 0 deaths. These are the recorded counts, not estimates of comparative risk. There is no separate control group, so the figures do not support a comparison between groups.

Zero recorded events in a small cohort does not establish that an event is impossible or that the device is free of risk. It describes only what the registry reports for this cohort and the recorded observation. The record does not provide event definitions beyond the serious/other categories, the observation period for adverse events, or details of how events were collected and attributed. It lists no top serious event terms. Further safety interpretation is limited by the cohort size and the absence of reported analysis details.

The study’s TERMINATED status should not be taken to mean that it ended because of safety concerns; the reason for termination is not reported in the registry record. Likewise, the adverse-event counts alone do not establish why the study ended or whether all planned observation was completed.

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

The registry record establishes that a sensor-enhanced custom night guard was studied with the aim of measuring bite compression forces in people with sleep-related bruxism. It describes an intended wearable period, a measurement frequency, a participant-level mean endpoint, and a cohort of 2 male participants. These details explain what the device was intended to measure and how the primary outcome was defined.

The record does not establish whether the device successfully recorded force, whether the hardware met its miniaturization objective, or whether usable force profiles were obtained. Although a primary endpoint is listed, no numerical endpoint result or statistical analysis is reported. Consequently, the record cannot show the average nocturnal clenching force observed, its variability, or the precision of an estimate.

The design also does not support a randomized comparison. No separate control group is described, and no allocation method is reported. The study should therefore not be interpreted as evidence that the night guard changed clenching, reduced bruxism, or performed better than another approach. Such conclusions would require comparative results that are not in the registry record.

The recorded enrollment of 2 is small, and the registry does not say how many participants completed the intended wear period or contributed endpoint data. It also does not report the reason the study was terminated. These gaps mean that the status and enrollment figures cannot be used to infer device failure, participant experience, or the cause of termination.

The appropriate interpretation is narrow: the record documents a technical measurement question and a planned continuous endpoint, but supplies no outcome analysis to resolve that question. The absence of a reported result is not evidence that the device did or did not work as intended. It means the registry record does not provide enough empirical information to assess the device’s measurement performance or the precision of the primary endpoint.

14. Why This Trial Matters Statistically

This study is statistically notable because its central challenge is measurement, not a randomized comparison of treatments. A sensor must convert a physical signal into recorded data, and the study’s objectives explicitly concern miniaturizing the hardware and capturing bite compression force profiles. Before a statistical estimate can be interpreted, readers need to know whether the device produced valid, usable measurements under the intended conditions.

The endpoint definition makes the intended summary clear: mean nocturnal clenching force relative to a participant-specific maximum voluntary clenching force. But a clear definition cannot replace results. No endpoint estimate, dispersion value, analysis, or information about the amount of usable data is reported. The statistical questions that ordinarily follow a continuous outcome—how variable it was, how precise its mean was, and whether measurements were complete—remain unanswered.

The single-cohort design also limits what statistical claims would be available. With no separate comparator, the focus is descriptive device feasibility rather than a controlled estimate of a difference between groups. The cohort includes 2 male participants, so any observed description would be highly dependent on the participants and recordings included. The registry does not report an analysis population or completed recording count.

Finally, a terminated status without a reported reason makes transparent outcome reporting especially important for interpretation. The record identifies the measurement question but does not report whether it was answered. The value of the entry is therefore in clarifying the intended endpoint and the gaps that prevent an evidence-based assessment of device measurement performance.

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 most direct limitation is the absence of posted endpoint results and analyses. Although the primary outcome is defined and its dispersion measure is named, no mean, standard deviation, or uncertainty interval is reported. The registry record therefore does not permit assessment of the observed force level or its precision.

The cohort consists of 2 male participants, and the record does not describe broader eligibility criteria or participant characteristics. The enrollment figure does not establish that both participants completed the intended 21 days of wear or contributed usable sensor data. The number of completed nights, usable recordings, and analyzed participants is not reported in the registry record.

No comparator group is listed, and the allocation method is not stated. The study cannot provide a randomized contrast based on the described design. The registry also does not report whether the hardware was successfully miniaturized, whether sensor recordings were validated, or how the data were processed beyond the stated participant-level mean. Details about calibration procedures, missing readings, and analysis methods are not reported.

The status is TERMINATED, but the reason for termination and whether the primary measurement objective was completed are not reported in the registry record. The registry does not provide the study’s own sample-size justification. Finally, the adverse-event counts are listed without detailed definitions or an observation-period description. Each of these omissions narrows the conclusions that can be drawn from the record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces. — NCT06688474.
• Registry record last updated 2026-03-03; status last verified 2026-01.
• Results first posted 2026-03-03.
• 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

NCT06688474 is a device study of the Otis Brux-Sensor Night Guard in a listed cohort of 2 male participants with diagnosed bruxism. The intended wear period was 21 days, over a 6+ hour sleep period each night. The primary outcome was mean nocturnal clenching force, expressed as a percentage of each participant’s maximum voluntary clenching force, with force sampled at 4 Hz.

The study started on 2024-08-05, has a recorded primary completion date of 2024-10-18, and is marked TERMINATED. The registry lists one primary outcome measure and no analyses. It reports no numerical endpoint result, analysis population, or reason for termination. The adverse-event record lists 0 serious events, 0 other events, and 0 deaths among the recorded cohort counts. Interpretation of measurement performance and precision is not possible from the registry record alone.