Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia (NCT04390750), a randomized na study. The primary outcome is Plaque Index.

2. Clinical Question

3. Trial Design

The registry identifies NCT04390750 as a completed, randomized, parallel-group trial sponsored by New York University. The listed enrollment is 60, and the condition is mild dementia. The trial is marked as having no masking. Its listed phase is NA. The record gives a start date of 2021-10-22 and a primary completion date of 2024-03-25.

The study compares Treatment Group 1, Treatment Group 2, and a control group. Treatment Group 1 is described as receiving a standard educational booklet, clinical oral health evaluation, and smart electronic toothbrush, with no instruction on oral hygiene technique. Treatment Group 2 is described as receiving a booklet, smart toothbrush, clinical evaluation, tailored technique instruction, and care partner coaching. The control group received a booklet and clinical evaluation without technique instruction. The registry also says that toothbrush data were downloaded for data collection in the treatment groups. Full arm descriptions are not reported in the registry record.

The primary endpoint is plaque index at 3 months. At that assessment, the posted group summaries include 18.0 participants in Treatment Group 1, 17.0 in Treatment Group 2, and 18.0 in the control group. The primary endpoint population description says 6 participants were withdrawn after the baseline visit and 1 participant did not complete the 3-month assessment. The record does not report a full accounting of participant flow by arm or the analysis population definition.

The registry lists additional behavioral and oral health outcomes, including toothbrushing frequency and duration, interdental cleaning frequency and technique, and oral health knowledge and hygiene scores. The record describes mediation objectives concerning care partner perspectives and oral hygiene behavior. Detailed protocol procedures, allocation concealment, the original sample-size justification, and the statistical analysis plan are not reported in the registry 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: 6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.

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 Plaque Index, measured over 3 months.

The primary endpoint is plaque index at 3 months, reported as a mean with a standard deviation. The registry describes the measure as the UNC Modified Green and Vermillion Oral Hygiene Index. Plaque is assessed per tooth using scores from 0, indicating no plaque, to 3, indicating plaque covering at least two-thirds of the tooth. The record states that the index value is the proportion of sites with plaque deposits and that higher index values indicate higher levels of plaque.

As a clinical measure of oral hygiene, plaque index complements behavior measures such as toothbrushing frequency and duration. Behavior can describe what participants do, while a clinical index assesses plaque deposits at the evaluation. In general, considering both behavior and a clinical measure can help distinguish changes in reported or recorded routines from changes in oral hygiene status. The registry’s stated objective links clinical outcomes with oral hygiene behavior and oral health skills.

The endpoint is presented as a mean, so comparisons describe average index values in the groups rather than the experience of every participant. General interpretation of a mean should account for the spread of individual observations, which is why the posted standard deviations are relevant. The registry’s primary endpoint results do not include a separate posted estimate for gingival index.

7. Results Posted in the Registry

• Treatment Group 1: mean 0.55 versus 0.48 on control; difference 0.07 (95% CI -0.15 to 0.29), standardized effect d = 0.21; z-test p = 0.538.
• Treatment Group 2: mean 0.41 versus 0.48 on control; difference -0.07 (95% CI -0.26 to 0.12), standardized effect d = -0.24; z-test p = 0.469.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Oral Health Hygiene Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Treatment Group 1: mean 1.83 versus 1.78 on control; difference 0.05 (95% CI -0.32 to 0.42), standardized effect d = 0.09; z-test p = 0.793.
  • Treatment Group 2: mean 1.64 versus 1.78 on control; difference -0.14 (95% CI -0.43 to 0.15), standardized effect d = -0.31; z-test p = 0.352.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment Group 1 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment Group 2 and the control. The interval gives the range of effects that remain compatible with the data.

Oral Health Knowledge Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Treatment Group 1: mean 0.71 versus 0.73 on control; difference -0.02 (95% CI -0.14 to 0.10), standardized effect d = -0.11; z-test p = 0.746.
  • Treatment Group 2: mean 0.81 versus 0.73 on control; difference 0.08 (95% CI -0.02 to 0.18), standardized effect d = 0.54; z-test p = 0.106.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment Group 1 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment Group 2 and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists a range of secondary questions, including brushing frequency and duration, interdental cleaning, technique, and oral health scores. Detailed posted secondary results include oral hygiene hygiene score and oral health knowledge score at 3 months. Across these outcomes, the unadjusted treatment-versus-control estimates do not form a consistent pattern in which both treatment groups move in the same direction across measures. The corresponding intervals include zero, so the posted summaries do not establish clear group differences.

These secondary outcomes complement the primary plaque index by addressing knowledge, skills, and oral health behavior that may relate to clinical hygiene. The registry’s objectives also propose that care partner factors and behavior could mediate clinical outcomes. However, the posted secondary summaries alone cannot show that changes in knowledge or behavior explain the plaque-index result. Mediation requires a specified analysis of the relevant variables and relationships; those results and methods are not reported in the registry record.

Unadjusted secondary findings generally carry less weight than a prespecified primary comparison because multiple outcomes and comparisons create more opportunities for apparently notable results to arise by chance. In general, multiplicity procedures can address the increased false-positive risk, but the registry does not report whether an adjustment was planned or applied. The secondary results should therefore be viewed as supportive or exploratory evidence rather than as independent confirmation of the primary endpoint.

The registry lists 12 secondary outcome measures as posted, while the available detailed results do not provide a complete account of every behavioral measure named in the study description. Any interpretation should distinguish between outcomes listed as objectives and outcomes for which numerical results are actually reported. Results for additional secondary measures and the analysis methods used for them are not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Frequency of Toothbrushing
• Frequency of Toothbrushing
• Duration of Toothbrushing
• Duration of Toothbrushing
• Frequency of Interdental Cleaning
• Frequency of Interdental Cleaning
• Interproximal Cleaning Technique
• Interproximal Cleaning Technique

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is a continuous measure summarized by group means and standard deviations. A mean gives the average observed index value within a group. A standard deviation describes the spread of participant values around that group mean; it is not the uncertainty in the mean itself. In general, a group with a larger standard deviation has more variability in its observed values, which can make a between-group estimate less precise when sample sizes are similar.

What does a mean difference describe?

The unadjusted mean difference compares the control-group mean with the mean in one treatment group, using the direction indicated by the posted comparisons. For Treatment Group 1, the reported difference is 0.07; for Treatment Group 2, it is -0.07. These are endpoint summary comparisons rather than estimates adjusted for baseline values or other participant characteristics. Whether baseline adjustment or other covariate adjustment was part of the sponsor’s model is not reported in the registry record.

The reported unadjusted confidence intervals are based on the posted group summaries. In general, an interval gives a range of values that are reasonably compatible with the estimate under the method’s assumptions. Its width reflects precision: wider intervals allow a broader range of possible differences. These intervals are not a range containing a fixed proportion of individual participants, and they do not assign a probability to the true value after observing the data.

What does the sponsor-reported model add?

The registry reports a linear mixed effects model and labels the reported parameter as an interaction coefficient. The model coefficients are 0.00 for Treatment Group 1 versus control and -0.09 for Treatment Group 2 versus control. A linear mixed effects model is a general approach for continuous outcomes that can represent relationships among observations using fixed and random effects. In general, such models can be useful when observations are grouped or repeated, because those data may not be statistically independent. The exact model specification, included observations, covariance structure, and interpretation of the interaction term are not reported in the registry record, so those details should not be inferred from the model label alone.

The sponsor-reported model results and the unadjusted mean differences answer related but not necessarily identical statistical questions. The mean differences are direct comparisons of posted endpoint summaries. The mixed model reports interaction coefficients under its model structure. Since the registry does not give the full model specification, the interaction coefficients should be described using the registry’s label rather than assigned a more detailed interpretation.

How should p-values be read?

The unadjusted comparisons report p = 0.538 for Treatment Group 1 and p = 0.469 for Treatment Group 2. The sponsor-reported model gives p = 0.939 and p = 0.103, respectively. In general, a p-value measures how unusual data at least as incompatible with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is correct, nor does it show whether an effect is important to participants. Interpretation should consider the estimated difference and its confidence interval alongside the p-value.

The posted analyses include both sponsor-reported model results and simple unadjusted recalculations from endpoint summary statistics. The recalculations do not reproduce the full trial analysis and do not incorporate unreported participant-level information. The record marks the discrepancy indicator as false. The trial’s full analysis plan, including any prespecified contrasts, adjustment choices, or handling of repeated measurements, is not reported in the registry record.

What does variability mean for this endpoint?

In general, variation in plaque-index values across participants affects how well a group mean estimates the group’s average. When individual values vary substantially, an estimate based on a modest group count can remain uncertain even if its point estimate appears different from another group’s. The group standard deviations and the confidence intervals provide complementary information: the former describe observed spread, while the latter describe uncertainty in a comparison. Neither alone describes every participant’s outcome.

The registry also lists behavioral outcomes and study objectives involving mediation. Mediation analysis generally asks whether an intervention-outcome relationship may operate through an intermediate variable. For example, the study description names care partner self-efficacy, cueing methods, FOCUSED Communication, and oral hygiene behavior among proposed mediators. The methods and results for those mediation analyses are not reported in the registry record. The existence of a stated objective does not establish that a pathway was measured, analyzed, or supported by results.

11. Confidence Intervals and Precision

Precision is reflected in the range of values compatible with an estimate under the statistical method. The unadjusted 95% confidence interval for Treatment Group 1 versus control is -0.152 to 0.292 around a mean difference of 0.07. For Treatment Group 2 versus control, the interval is -0.260 to 0.120 around a mean difference of -0.07. Each interval spans zero and allows values on either side of zero. Thus, the posted estimates do not pin down a single direction of difference with much certainty.

The sponsor-reported model intervals are -0.11 to 0.11 for Treatment Group 1 versus control and -0.21 to 0.02 for Treatment Group 2 versus control. These intervals also include zero. Their estimates are model interaction coefficients, so they should not be treated as interchangeable with the unadjusted mean-difference intervals. The model specification and exact relationship between these analyses are not reported in the registry record.

In general, a 95% confidence interval describes the performance of a method across repeated use under its assumptions: intervals constructed this way would cover the target value in 95% of repetitions. It does not mean that there is a 95% probability that the true value lies within the particular interval already calculated. Confidence intervals also do not show whether the full range is clinically important. The registry does not report a threshold for a clinically meaningful plaque-index difference, so clinical importance cannot be determined from the intervals alone.

The group counts at the endpoint are 18.0, 17.0, and 18.0, and the standard deviations vary across groups. In general, limited group information and variability can leave estimates imprecise. The confidence intervals make that uncertainty visible; a point estimate alone would conceal it. The sample-size illustrations address planning under stated assumptions, but they do not narrow the uncertainty in the observed trial results.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes or total event counts. The planning assumptions listed with these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each illustration uses a stated fraction of the observed effect as the effect to detect. These assumptions describe the planning calculations, not the trial’s original design; the original design assumptions and sample-size justification are not reported in the registry record.

In general, power is the chance that a specified analysis will detect an effect of the size assumed in the calculation, if that effect is present and the planning assumptions hold. The 80% column gives the estimated participants per arm for a design with 80% power under the stated assumptions. The 90% column gives the corresponding planning figure for 90% power. A higher target power generally requires more participants when the other assumptions stay the same.

The rows use 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The smaller the effect targeted for detection, the more participants are needed in these illustrations. This follows because smaller differences are harder to distinguish from random variation. The observed differences in a small trial can be unstable, so planning around them should not be taken as a recommendation or as a validated estimate of the effect a future study should expect.

These calculations are planning illustrations based on observed effects, not observed power. They do not describe the probability that the completed trial produced a statistically significant result, and they do not replace the trial’s unreported original design rationale.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.070; pooled standard deviation σ = 0.341.
2. n = 2 × (1.96 + 0.842)² × 0.341² / 0.070² = 371.6, rounded up to 372 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.0700000000000001                      # observed difference in means
sigma <- 0.340587727318528                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4390750)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 372 (80% power), 498 (90% power)
 75% of observed effect: n per arm = 661 (80% power), 885 (90% power)
 50% of observed effect: n per arm = 1,487 (80% power), 1,990 (90% power)
power.t.test: 372.6 
Simulated power at n = 372 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analyses as linear mixed effects model interaction coefficients. For Treatment Group 1 versus control, the reported coefficient is 0.00, with a 95% confidence interval from -0.11 to 0.11 and p = 0.939. For Treatment Group 2 versus control, the coefficient is -0.09, with a 95% confidence interval from -0.21 to 0.02 and p = 0.103. Both model intervals include zero.

The unadjusted recalculations compare the posted endpoint means. They give mean differences of 0.07 for Treatment Group 1 versus control and -0.07 for Treatment Group 2 versus control. These are simple comparisons from summary statistics, not a reconstruction of the sponsor’s model using participant-level observations. The sponsor’s model may reflect features not present in the summary-statistic recalculations, but the precise model specification and the interpretation of its interaction coefficients are not reported in the registry record.

The registry’s discrepancy indicator is false. The sponsor-reported analysis therefore does not have a flagged discrepancy with the recalculation. The sponsor’s own analysis remains the primary registry-reported inferential analysis; the unadjusted recalculations are supplementary descriptions that help readers see the endpoint mean differences and their uncertainty.

15. Multiplicity, Missing Data and Analysis Populations

The registry reports several objectives and a set of secondary outcomes, in addition to the primary plaque-index endpoint. Multiple comparisons can increase the chance of obtaining at least one apparently unusual result when all null hypotheses are true. In general, prespecifying a primary outcome and controlling multiplicity for secondary testing can help distinguish confirmatory from exploratory evidence. The registry record does not report a multiplicity plan, such as a hierarchy of tests or an adjustment across outcomes and contrasts.

The record gives the primary endpoint population note that 6 participants were withdrawn after the baseline visit and 1 participant did not complete the assessment at 3 months. It does not report the reasons for withdrawal, arm-specific participant flow, or the method used to handle missing endpoint values. The posted endpoint group counts are 18.0, 17.0, and 18.0, but the record does not define whether these counts represent an intention-to-treat population, a complete-case population, or another analysis population.

In general, missing data can affect estimates if the likelihood of missing an outcome is related to the outcome itself or to participant characteristics. Common approaches rely on assumptions about why observations are missing; without the trial’s chosen method and assumptions, the potential influence of missingness cannot be assessed from the registry summaries alone. The record also does not report sensitivity analyses for missing outcomes.

The registry gives sponsor-reported mixed effects model results but does not provide enough detail to determine how those models treated incomplete outcome histories or which participants were included. Details of interim analyses, the prespecified statistical analysis plan, and any protocol deviations are not reported in the registry record. These omissions limit assessment of whether all analyses followed a prespecified plan and how robust the estimates are to alternative analytic choices.

16. 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.

Most frequent non-serious adverse event terms

The registry lists 20 participants at risk for serious adverse events in each group. The reported serious adverse event count is 0 in Treatment Group 1, 0 in Treatment Group 2, and 0 in the control group. Deaths are also reported as 0 in each group. For other adverse events, the counts are 1 in Treatment Group 1, 2 in Treatment Group 2, and 0 in the control group.

These are event counts in the registry’s safety record. They do not, by themselves, provide detail about the nature, timing, severity, or relationship of the other adverse events to the study intervention. The record lists no serious adverse event terms. The available figures should be read as the reported counts, not as proof that no unreported event occurred or as a general safety conclusion. Further detail about adverse event definitions, collection procedures, and follow-up is not reported in the registry record.

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

The posted primary results describe plaque-index means at 3 months and comparisons of each treatment group with the control group. The observed means are 0.55 for Treatment Group 1, 0.41 for Treatment Group 2, and 0.48 for control. The unadjusted confidence intervals for both treatment-control mean differences include zero, as do the intervals for the sponsor-reported model coefficients. The estimates therefore remain uncertain about the direction and magnitude of any group difference.

This does not establish that the groups are identical, nor does it demonstrate that the intervention has no effect. A study can produce estimates compatible with a range of effects when the available information is limited or the outcome is variable. Conversely, a numerical difference between group means does not by itself establish a causal effect. The registry’s randomized design supports a comparison between assigned groups, but full assessment also depends on participant flow, analysis methods, missing-data handling, and adherence details, some of which are not reported.

The study description includes objectives concerning oral hygiene behavior, oral health skills, and mediation through care partner variables. The posted primary result cannot answer whether those pathways explain the outcome. Results for the listed behavioral measures and detailed mediation analyses are not reported in the registry record. Nor does the plaque-index result establish a result for gingival index, which is named in the study objectives but not included among the posted primary results.

In general, statistical evidence should be read alongside the endpoint definition, estimate, confidence interval, study design, and completeness of reporting. The record supports a description of the observed group summaries and reported model analyses. It does not by itself establish clinical importance, explain why the estimates differ, or determine how the findings apply beyond the enrolled trial population.

18. Why This Trial Matters Statistically

This trial is statistically informative because it places an intervention with behavioral and care partner components alongside both a control group and a treatment group receiving a smart toothbrush without technique instruction. That design creates comparisons relevant to different intervention components, although the registry does not provide enough full protocol detail to determine the intended interpretation of every contrast.

The outcome structure also connects clinical measurement with behavior. Plaque index is a clinical endpoint, while brushing and interdental cleaning measures concern daily practices. Such outcomes answer different kinds of questions. In general, an intervention may influence behavior without producing a detectable difference in a clinical endpoint during the observed follow-up, or a clinical measure may change without a clear behavioral explanation. The registry’s objectives recognize these linked questions, while the posted primary result addresses plaque index.

From a statistical perspective, the key feature is uncertainty: both unadjusted primary confidence intervals span zero, and the sponsor-reported model intervals do as well. Reporting estimates and intervals alongside p-values allows readers to see the range of effects compatible with the analyses rather than relying on a threshold alone. The planning illustrations also show how strongly sample-size requirements depend on the size of the effect a future study aims to detect.

The record additionally makes visible important limits of registry-based interpretation. It does not report the original sample-size rationale, full analysis plan, missing-data method, or detailed mediation results. These elements matter for judging whether findings were prespecified and how robustly they answer the study’s broader objectives. The trial is therefore a useful example of why estimates, design details, and transparent reporting must be considered together.

19. 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 registry record gives a short description of the intervention arms, and the arm descriptions are truncated. Treatment Group 2 is described as receiving tailored technique instruction and care partner coaching, but the full content and delivery of those components are not reported. The record also does not provide detailed information about participant eligibility beyond mild dementia, baseline characteristics, adherence, or the extent to which the intervention was received.

The primary endpoint summaries and model results are available, but the registry does not report the full statistical analysis plan or model specification. In particular, it does not explain the interaction term, any adjustment for baseline measurements, or how incomplete outcome data were handled. The primary endpoint population note identifies withdrawals and a missed 3-month assessment, but does not give reasons or arm-specific flow.

The registry describes objectives involving gingival index, behavior, and mediation, yet the posted primary result concerns plaque index and detailed mediation methods and results are not reported. The available secondary summaries do not cover every outcome listed in the study description. The multiplicity approach and original sample-size justification are also not reported in the registry record.

General limitations of the posted evidence include uncertain estimates, because the primary confidence intervals include zero, and reliance on summary-level data for unadjusted recalculations. The record lists enrollment of 60, while the endpoint summaries include the group counts stated for the 3-month results. Without a complete participant-flow account and analysis-population definition, the relationship between enrolled participants and each analysis cannot be fully evaluated from the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia — NCT04390750.
• Registry record last updated 2025-12-09; status last verified 2023-10.
• Results first posted 2025-11-28.
• 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.

23. Record Summary

NCT04390750 is a completed randomized parallel-group trial sponsored by New York University, with listed enrollment of 60 and no masking. It evaluates a care partner-assisted oral health intervention for individuals with mild dementia. The primary posted endpoint is plaque index at 3 months.

Endpoint means were 0.55 for Treatment Group 1, 0.41 for Treatment Group 2, and 0.48 for control. The unadjusted treatment-control intervals and the sponsor-reported mixed-model intervals include zero. The record also posts secondary oral health score results and safety counts, including 0 serious adverse events and 0 deaths in each group. Important details about the original sample-size rationale, missing-data methods, multiplicity, and full analysis plan are not reported in the registry record.