Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care (NCT07586072), a registered phase not stated study. The primary outcome is Change in Total Fonseca Anamnestic Index Score.

2. Clinical Question

The question is about short-term patient-reported symptom change under care selected in clinical practice, not about the causal effect of assigning one approach instead of another. The study also evaluated selected questionnaire items, changes in symptom-severity categories, and clinically recorded treatment-related adverse events as secondary outcomes. Because participants entered management pathways through clinical decision-making rather than random allocation, differences between cohorts may reflect differences in symptoms, clinical indications, preferences, or other characteristics as well as treatment. The registry record does not report numerical findings for the symptom outcomes, so the extent or direction of change cannot be described from this record.

3. Trial Design

This is a prospective observational study of adults with bruxism-related and temporomandibular disorder symptoms. The registry record gives an enrollment of 60 and describes three clinically selected management pathways: occlusal splint therapy, botulinum toxin type A injection, and combined medical-splint therapy. The study status is completed. The recorded start date is 2024-08-05, and the primary completion date is 2025-08-01.

Management was selected through routine clinical decision-making, taking account of clinical indication, symptom profile, shared decision-making, and patient preference. Assignment was not randomized. The approaches therefore should not be interpreted as randomized treatment arms or as equivalent groups that differ only in their management. The record itself cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison.

The principal assessment was the Fonseca Anamnestic Index at baseline and after 3 months. The stated primary objective was to describe within-cohort change in total scores and explore whether longitudinal change patterns differed among the cohorts. Secondary assessments concerned selected index items, severity-category changes, and treatment-related adverse events recorded clinically.

The splint pathway used custom-made maxillary stabilization splints. The botulinum toxin pathway involved a single injection session. The combined pathway paired a custom-made splint with a short-term pharmacological regimen of thiocolchicoside and tenoxicam. Some procedural and use details are incomplete in the registry record. The record does not report a randomized allocation procedure, a prespecified statistical analysis plan, or details sufficient to reconstruct all treatment instructions. It also does not report numerical primary-outcome findings.

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.

Before assignment: No participants were excluded after enrollment. All enrolled participants were assigned to a treatment arm and included in the final analysis.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All participants with baseline and 3-month follow-up Fonseca Anamnestic Index data were included in the analysis.

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.

Population: All participants assigned to the treatment arms were included in the baseline analysis population.

6. Primary Endpoint

The registry lists the primary outcome as Change in Total Fonseca Anamnestic Index Score, measured over Baseline to 3 months.

The primary endpoint is change in the total Fonseca Anamnestic Index score between baseline and the 3-month follow-up. The index is a 10-item, symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Its total ranges from 0 to 100, with higher scores indicating more severe symptoms. The registry defines change as the pretreatment score minus the post-treatment score, so a higher positive change represents a greater reduction in reported symptom severity.

A patient-reported questionnaire captures symptoms from the participant’s perspective rather than relying only on examination findings. Repeated measurement allows description of how scores changed over the study interval within each clinically selected cohort. It does not, by itself, establish that a management approach caused the change: symptoms can change over time for reasons other than treatment, and the cohorts were not formed by random assignment.

The primary analysis population is described as participants with both baseline and 3-month index data. The registry record does not report the numerical mean changes, their standard deviations, confidence intervals, or inferential results. Consequently, the scale’s meaning and the direction of its change score can be explained, but the amount and precision of observed change cannot be established from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record describes a prospective observational design and a continuous primary outcome summarized as a mean with standard deviation. These features define the kind of data collected, but the registry record does not report the detailed statistical procedures used to analyze the primary outcome. The following concepts explain how such results are generally read; they are not claims about an unreported analysis plan.

What does a mean change describe?

A mean change represents the average of participants’ change scores within a group. Here, each change score is the baseline Fonseca Anamnestic Index total minus the 3-month total. The definition makes positive values correspond to reductions in the score. A mean condenses the group’s changes into one summary, but it does not show how similar or different individual participants’ changes were. The standard deviation describes the spread of individual values around the mean; it is not the uncertainty in the mean itself.

How should a confidence interval be read?

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the statistical method used. A narrower interval indicates greater precision for that estimate, while a wider interval indicates more uncertainty. An interval for a mean change would address the precision of that cohort’s estimated average change. An interval for a difference between cohorts would address the precision of that contrast. The registry record does not report such intervals for the primary endpoint, so their width and whether they include a null value are not reported in the registry record.

What is the distinction between change and a between-group contrast?

A within-group change compares follow-up with baseline among participants in the same cohort. A between-group contrast compares changes across cohorts. The first is descriptive of change over time; the second asks whether those changes differ. Neither automatically identifies a causal treatment effect in a non-randomized study. The management pathways were selected through clinical decision-making, so differences in indications, symptoms, and preferences may contribute to any observed contrast. Statistical adjustment can address only measured factors included in an appropriate analysis and cannot guarantee removal of all confounding. The registry record does not report an adjustment method or covariate set.

Why does the allocation process matter?

Random allocation is used in some trial designs to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics. This study did not use random allocation. Its cohorts reflect clinical selection, so baseline differences are plausible and are relevant when interpreting comparisons. A difference in change between cohorts could be associated with the chosen management, but the design as described does not isolate that association from selection effects. This is a general limitation of non-randomized comparisons, not evidence that any particular imbalance occurred.

What does statistical significance say?

In general, a p-value measures how compatible data are with a specified statistical null model, given the assumptions of the test. It does not measure the probability that a treatment works, nor does it describe the size or clinical importance of an effect. An estimate and its precision are needed to understand magnitude and uncertainty. The registry record does not report a primary-outcome p-value, test, or model. Statistical significance therefore cannot be assessed from the record.

How should planning calculations be understood?

Sample-size illustrations are planning tools rather than observed outcomes. General planning calculations can describe the number of participants per arm associated with a chosen target power and an assumed effect size under specified assumptions. The registry record states that its planning illustration is based on the observed effect and specified assumptions, but it does not provide numerical planning outputs in the record. Such illustrations are not observed power and do not show that the study had a particular probability of detecting an effect after the fact. The record does not report that these illustrations formed the original design justification.

What can be said about distributional assumptions?

Mean-based methods often rely on assumptions about the distribution of the outcome or the model’s errors. General methods may be sensitive to skewness, outliers, unequal variability, or repeated measurements being correlated within a participant. Appropriate methods depend on the data and analysis objective. The registry record does not report diagnostic checks, a repeated-measures model, a method for handling non-normality, or any other detailed modeling choices. No specific method should be inferred from the stated outcome summary alone.

For all these reasons, the reported design and endpoint identify what the analysis was intended to describe, but they do not substitute for the numerical results and analysis details needed to judge effect size, precision, or comparative evidence.

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("Occlusal Splint Therapy", "Botulinum Toxin Type A Injection", "Combined Medical-Splint Therapy")
n   <- c(20, 20, 20)
m   <- c(33.75, 27.25, 39.25)
sp  <- c(13.85, 12.62, 11.04)
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  Occlusal Splint Therapy  20  33.750  13.850  27.268  40.232
CARM  Botulinum Toxin Type A Injection  20  27.250  12.620  21.344  33.156
CARM  Combined Medical-Splint Therapy  20  39.250  11.040  34.083  44.417

11. Multiplicity, Missing Data and Analysis Populations

The study describes a primary outcome and several secondary outcome domains: selected Fonseca Anamnestic Index items, severity-category changes, and treatment-related adverse events. Assessing multiple outcomes can create multiplicity: when many statistical questions are tested, the chance of at least one apparently notable result may increase. General approaches include identifying a primary question in advance, adjusting inference for multiple tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy among secondary tests, or a detailed statistical analysis plan. It is therefore not possible to tell how multiplicity was handled.

The primary endpoint population is defined by having both baseline and 3-month index data. This makes outcome availability part of the analysis definition. The registry record does not report how many participants lacked either assessment, why data might be missing, or whether missing outcomes were imputed, excluded, or addressed through sensitivity analyses. It also does not state whether reasons for missingness differed by management cohort. Those details matter because an analysis restricted to complete measurements may not represent everyone enrolled if availability of follow-up data is related to symptoms or care.

The record does not describe the population used for each secondary outcome, nor does it report whether all enrolled participants contributed to every analysis. The listed adverse-event risk sets are distinct reporting information and should not be assumed to define the primary symptom analysis population. Without analysis-population counts and missing-data procedures, the completeness and comparability of the outcome analyses cannot be assessed.

These are reporting gaps in the registry record, not proof that the study did not use a particular procedure. The analysis plan, handling of missing data, and multiplicity approach are not reported in the registry record.

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 registry reports zero serious adverse events and zero other adverse events in each management cohort. The corresponding adverse-event records list 20 participants at risk in each cohort. Deaths are reported as zero in each cohort, and no serious adverse-event terms are listed.

These figures describe the events recorded in the registry for the stated risk sets. A reported zero means that no event of that category was recorded in the registry data; it does not establish that an approach has no risk or that no symptoms or problems occurred outside the recorded categories. The record describes treatment-related adverse events as clinically recorded, but it does not give further detail about the method or duration of safety surveillance, event definitions, or how events were solicited.

Safety counts also have limited ability to characterize uncommon events, particularly when the reported risk set is small. General interpretation should consider both the number of observed events and the extent of monitoring and follow-up. The record does not report confidence intervals or a comparative safety analysis. Because the management pathways were clinically selected rather than randomized, the event counts should not be treated as a controlled comparison of safety between approaches.

The registry’s zero counts are therefore a description of recorded events, not proof of absence of harm and not evidence that one pathway is safer than another.

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

This study is designed to describe short-term patient-reported symptom changes among adults managed through three clinically selected pathways. Its primary measure is the change in total Fonseca Anamnestic Index score from baseline to 3 months, with positive values defined as reductions in the score. That outcome and direction are stated in the registry record, but numerical primary results are not reported there. The record therefore does not show how much scores changed, how variable those changes were, or how precise the estimates were.

The observational design supports description of what happened over time in the selected cohorts, but it does not support attributing any change solely to the management approach. Treatment selection was based on clinical indication, symptom profile, shared decision-making, and patient preference. Consequently, the cohorts may differ for reasons related to both treatment choice and outcome. A between-cohort contrast, if available elsewhere, would need to be interpreted with that selection process in mind.

The study also does not establish how the results apply to people outside the population enrolled or to other care settings. The registry record does not report detailed participant characteristics, recruitment procedures, or numerical outcome findings needed to judge representativeness. Its adverse-event counts report zero serious and zero other events in each cohort, but those counts alone cannot establish absence of risk or comparative safety.

In general, evidence is most informative when the estimated effect, its uncertainty, the analysis population, and the study design are considered together. Here, the outcome definition and design can be described, but the primary numerical estimates, inferential results, missing-data details, and full statistical analysis procedures are not reported in the registry record. The record thus documents the question and the measurement approach, not a numerical answer to the question.

14. Why This Trial Matters Statistically

The record is statistically informative because it makes clear that the three management pathways were clinically selected rather than randomly assigned. That distinction determines what comparisons can mean. Within-cohort changes describe symptom scores over time, while differences between cohorts may reflect both management and the reasons that led clinicians and participants to select each pathway. Keeping those questions separate prevents an observational comparison from being read as if it were a randomized trial.

The endpoint is patient-reported and has an explicit direction: baseline score minus follow-up score, with higher positive values representing a greater reduction in reported symptoms. Stating the scale and change convention helps avoid reversing the interpretation of a change estimate. It also clarifies that the primary outcome is a continuous score, while severity-category shifts and selected items are secondary outcomes that address related but different aspects of symptoms.

The record also illustrates why outcome definitions alone are not enough for evaluating evidence. Interpretation requires numerical estimates and measures of uncertainty, as well as information about analysis populations, missing data, and the statistical methods used. Those primary numerical results and several analysis details are not reported in the registry record. The available safety counts are descriptive and do not provide a controlled comparison.

These features matter for biostatistical reading because they distinguish a stated research objective from an evidential conclusion. The study can be characterized by its prospective observational approach, its clinical selection process, and its patient-reported endpoint, while the size and precision of any symptom changes remain undetermined from the registry record. Recognizing both what the design can describe and what it cannot establish is central to interpreting clinical cohort comparisons responsibly.

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 main trial-specific limitation is non-random allocation. Management reflected clinical indication, symptom profile, shared decision-making, and patient preference. These factors can create systematic differences between cohorts, so their outcomes are not directly comparable as though they came from interchangeable groups. The record itself notes that the arms are not a like-for-like control comparison.

The primary endpoint requires baseline and 3-month questionnaire data. The record does not report the number of participants contributing complete data by cohort, the reasons for unavailable assessments, or how missing data were handled. Without that information, it is not possible to assess whether the analyzed participants represent all enrolled participants or whether follow-up availability could affect comparisons.

Numerical primary-outcome estimates and their precision are not reported in the registry record. Detailed statistical methods, including any adjustment for baseline differences, repeated-measure modeling, multiplicity procedures, or sensitivity analyses, are also not reported. This limits independent assessment of both the analysis and its uncertainty.

The record’s treatment descriptions are incomplete in places, so not all administration and use details can be reconstructed. It also does not report detailed participant characteristics or the criteria used to select each pathway. These omissions limit assessment of applicability and of the extent of clinical differences between cohorts.

Finally, adverse-event reporting is limited to recorded counts, without detailed surveillance procedures or comparative analysis. Zero recorded events should not be interpreted as evidence that events could not occur. These limitations concern what can be evaluated from the registry record and do not establish that any unreported procedure was absent from study conduct.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care — NCT07586072.
• Registry record last updated 2026-07-30; status last verified 2026-05.
• Results first posted 2026-07-30.
• 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 registry record describes a completed prospective observational study of adults with bruxism-related and temporomandibular disorder symptoms. Participants received clinically selected occlusal splint therapy, botulinum toxin type A injection, or combined medical-splint therapy; allocation was not random. Enrollment is listed as 60, with a start date of 2024-08-05 and primary completion date of 2025-08-01.

The primary outcome was change in total Fonseca Anamnestic Index score from baseline to 3 months. The index is a 10-item symptom questionnaire with totals from 0 to 100; the change convention makes positive values indicate a reduction in score. The primary analysis population is described as participants with baseline and 3-month data.

The registry record does not report numerical primary symptom results, their precision, detailed statistical methods, or missing-data procedures. It reports zero serious and zero other adverse events in each cohort, with zero deaths recorded in each. These counts are descriptive and do not establish comparative safety.