Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population?: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population? (NCT02864901), a randomized phase 2 study. The primary outcome is Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation.

2. Clinical Question

The trial asks whether an antiplaque chewing gum containing KSL-W, given to generally healthy participants, can affect dental plaque regrowth and whether its use is associated with safety or tolerability findings. The registry record describes a comparison with chewing gum placebo and a whole-mouth dental examination at baseline and after treatment. Its stated focus includes both effectiveness in reducing dental plaque and assessment of local oral, systemic, and serious total-body reactions.

The registry record names plaque regrowth as a condition and lists a secondary outcome concerning whole-mouth change in plaque regrowth, based on regions and surfaces of the upper and lower jaw. However, numerical results for that outcome are not reported in the registry record. The primary outcome description likewise identifies examination domains and time points, but does not provide the observed outcome values or a single comparison estimate. The available record therefore establishes the clinical question and study structure, but not the magnitude or precision of any treatment contrast.

3. Trial Design

This was a randomized, triple-masked, parallel-group Phase 2 trial sponsored by the U.S. Army Medical Research and Development Command. It is listed as completed. The record gives an enrollment of 27 and describes a generally healthy participant population. The listed groups were KSL-W 30 mg and Chewing Gum Placebo, with each regimen described as 3 times per day over 4 treatment days.

In a randomized study, assignment to groups is intended to reduce systematic differences between participants at the start of treatment. A parallel design means participants are assigned to one group rather than crossing between treatment groups as part of the listed design. Triple masking indicates that the registry identifies three masked roles, but which roles were masked and how masking was maintained are not reported in the registry record. The method used to generate or conceal the random assignment is also not reported in the registry record.

The record lists a study start of 2016-10 and a primary completion of 2016-11. Its primary outcome timeframe is baseline and Day 4 following three-days of chewing gum treatment; the outcome description separately refers to a Day 4 exam following 72-hours of treatment. The regimens are described as continuing over 4 treatment days. These are the registry’s descriptions; further scheduling details are not reported in the registry record.

The primary outcome is titled as a safety, tolerability, and effectiveness assessment of KLS-W delivered in a chewing-gum formulation. The intervention name elsewhere is KSL-W. The primary description identifies vital signs and a whole-mouth dental examination, including named jaw surfaces, to assess local oral mucosal reactions, systemic reactions, and serious total-body reactions. A secondary outcome concerns change in plaque regrowth using region-specific subscores and standardized QHT measures. Specific protocol methods, eligibility criteria, and the planned statistical analysis 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 26 Male and female subjects undergoing exam following 72-hours of Chewing Gum Treatment with results compared to baseline

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 Safety, Tolerability and Effectiveness in Reducing Dental Plaque of KLS-W Delivered in a Chewing Gum Formulation, measured over Baseline, and Day 4 Following Three-days of Chewing Gum Treatment.

The listed primary endpoint concerns safety, tolerability, and effectiveness in reducing dental plaque, expressed as a number of participants. Its timeframe is baseline and Day 4 following three-days of chewing gum treatment. The description says that the Day 4 examination followed 72-hours of treatment and included vital signs and a whole-mouth dental examination. The examination covered maxillary buccal, maxillary lingual, mandibular buccal, and mandibular surfaces, and assessed local oral mucosal reactions, systemic reactions, and serious total-body reactions.

This type of endpoint is used to organize clinical observations around a defined examination and follow-up time. A participant count can be useful for describing how many people had a recorded event, provided that the event definition and analysis population are clear. The registry labels the outcome unit as participants and its parameter as NUMBER. It does not give the actual endpoint values, define a single event threshold for the combined safety and plaque-related title, or report a treatment-effect estimate. Those details are not reported in the registry record.

The record also lists a secondary outcome for whole-mouth change in plaque regrowth, with subscores from specified regions and surfaces and standardized QHT measures. That outcome is more directly described as a plaque-regrowth assessment, but its numerical findings are not reported in the registry record. The endpoint description should therefore be read as a statement of what was intended to be examined, not as evidence of a particular observed change. The title uses “KLS-W,” while the intervention name is “KSL-W”; the registry record does not explain this difference in spelling.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical context: a randomized trial compares groups assigned to different regimens, with random allocation intended to make baseline characteristics less systematically different on average. Randomization does not guarantee that groups will be identical, particularly in a small trial, and does not replace reporting the observed outcomes. The registry identifies this trial as randomized, but the allocation sequence method and concealment procedures are not reported in the registry record.

The study is listed as parallel-group. In a parallel design, each participant is assigned to one group for the comparison. Here, the listed regimens are KSL-W 30 mg and Chewing Gum Placebo, each taken 3 times per day over 4 treatment days. The record identifies triple masking. Masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting when the relevant people do not know group assignment. Which three roles were masked, whether masking was successful, and how the placebo was matched are not reported in the registry record.

The primary outcome is expressed as a number of participants, and the general outcome classification describes counts of participants with an event. A count outcome requires a clear definition of the event and a defined denominator. The endpoint description refers to safety, tolerability, effectiveness in reducing plaque, vital signs, and an examination of oral surfaces for local, systemic, and serious total-body reactions. It does not specify one event definition or give the actual primary outcome counts by group. As a result, the record does not permit reconstruction of a single binary comparison.

General statistical context: for a binary outcome, a group’s event count is usually interpreted alongside the number of participants evaluated. A comparison may be expressed in different ways, such as a difference in event proportions or a relative measure, but the appropriate measure depends on the question and analysis plan. No such estimate is reported in the registry record. No confidence interval, p-value, or model specification is listed for the primary outcome.

The registry lists a secondary plaque-regrowth outcome based on whole-mouth change and subscores from regions of the upper and lower jaw, buccal and lingual surfaces, using standardized QHT measures. Subscores can describe where measurements were taken and may preserve more detail than a single whole-mouth summary. To interpret such an outcome, readers would need the scoring rules, aggregation method, timing, missing-score handling, and numerical results. These details are not reported in the registry record.

General statistical context: a confidence interval is a range of estimates compatible with the observed data and the assumptions of the method. It conveys precision, not certainty, and its meaning depends on the chosen model and sampling assumptions. A p-value, when used, assesses how surprising data at least as extreme as those observed would be under a specified null model; it does not measure the probability that a treatment is effective. The registry record reports no confidence intervals or p-values and does not state the planned inferential method.

General statistical context: count outcomes can be more variable than a simple Poisson model allows when the variance exceeds the mean, a phenomenon called over-dispersion. In that setting, methods that allow extra variability may give more appropriate uncertainty estimates. Nothing in the registry record establishes that the primary outcome was analyzed with a count model, that over-dispersion was assessed, or that such a model was needed. Since the primary outcome is not reported numerically and no analyses are listed, model choice cannot be evaluated from this record.

The registry lists 2 outcome measures and 0 analyses. It also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. These points matter because readers cannot identify a single reported primary contrast or determine whether multiple comparisons were planned or adjusted. The statistical analysis plan, including the handling of multiple outcomes and time points, is not reported in the registry record.

General statistical context: sample-size calculations are planning tools based on assumptions about the outcome, effect to be detected, variability, significance level, and allocation. A planning illustration is not an observed result and does not show that a trial had a particular probability of detecting an effect after the data were collected. The record states that its planning illustration is based on a fraction of the observed effect and describes general assumptions, but numerical planning results and a trial-specific sample-size justification are not reported in the registry record. There is no basis to infer observed power from enrollment alone.

Finally, statistical interpretation depends on the analysis population and missing-data rules. The registry describes 26 subjects for the primary examination and 27 enrolled, but does not explain which participants were included in each analysis or how any missing observations were handled. Without the analysis population, endpoint values, and stated methods, the direction, size, and precision of the treatment comparison cannot be assessed.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 2 outcome measures, including a primary assessment and a secondary plaque-regrowth measure. The primary outcome description includes multiple assessment domains and identifies baseline and Day 4, while the registry notes that it has several categories or time points and is not reduced to one comparison. When multiple outcomes, components, or time points are examined, the chance of obtaining at least one apparently unusual result can increase if each is assessed separately. General statistical practice may address this through a prespecified hierarchy, adjustment, or careful interpretation, but the approach used in this trial is not reported in the registry record.

The registry lists 0 analyses. It does not provide an analysis plan, identify a primary contrast among the outcome components, or state whether any multiplicity adjustment was planned. Therefore, readers cannot determine which comparisons were intended to carry the main inferential interpretation or how a family of tests was handled. No numerical outcome results or inferential measures are reported either.

Missing-data handling and analysis populations are also unclear. The record gives enrollment of 27, describes 26 subjects for the primary examination, and lists 13 participants at risk in each adverse-event group. It does not explain whether the primary examination population included all randomized participants, whether participants withdrew or missed assessments, or how incomplete measurements were treated. The number and reasons for missing observations, if any, are not reported in the registry record.

These omissions do not establish that data were missing or that multiplicity affected results. They mean that the registry does not provide enough information to assess those issues. The planned statistical analysis, population definitions, and missing-data procedures are not reported in the registry record.

11. 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 adverse-event figures list 13 participants at risk in the KSL-W 30 mg group and 13 in the Chewing Gum Placebo group. In each group, the recorded serious adverse-event count is 0, the other adverse-event count is 0, and deaths are 0. No serious-event terms are listed. These figures are descriptive registry counts, not a comparison adjusted for other factors.

A count of 0 means that no events in that category are recorded for the listed group in this entry. It does not mean that the treatment has been established as free of risk, and it does not show how event collection, classification, or follow-up operated. The registry record does not report definitions for the adverse-event categories, the method of surveillance, or further detail on duration and completeness of safety follow-up. The primary examination description mentions local oral mucosal reactions, systemic reactions, and serious total-body reactions, but does not provide their observed values separately.

General statistical context: when an event is uncommon, a small group can have no recorded events even when the underlying event risk is not zero. Precision around a safety rate depends on the number observed and the number assessed, as well as complete and consistent event ascertainment. No confidence intervals or other uncertainty estimates for the safety counts are reported in the registry record. The figures should therefore be read narrowly as the posted counts for the stated groups, rather than as a definitive comparison of safety.

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

The trial record establishes that KSL-W 30 mg chewing gum was compared with chewing gum placebo in a randomized, triple-masked, parallel Phase 2 study in a generally healthy population. Both groups were assigned regimens described as 3 times per day over 4 treatment days. The planned assessment included a whole-mouth examination and vital signs, with plaque regrowth also listed as a secondary outcome. These details help define the clinical question and the type of observations intended.

What the record does not establish is the size or direction of a difference between groups. It gives no numerical primary endpoint results, plaque-regrowth scores, treatment-effect estimate, confidence interval, or p-value. There is therefore no basis in this entry to state whether plaque scores differed, how large any difference was, or how precisely a contrast was estimated. The absence of numerical findings should not be treated as evidence of no difference.

The adverse-event listing records zero serious events, zero other adverse events, and zero deaths in each group, with 13 participants at risk per group. These are limited descriptive safety counts. They do not answer the plaque-effectiveness question and do not establish that uncommon events could not occur. Details needed to interpret the completeness and scope of safety ascertainment are not reported in the registry record.

General statistical context: a trial’s results are interpreted by considering the estimated effect, its uncertainty, the outcome definition, and the population studied. A point estimate without a measure of precision can be difficult to assess; without any reported estimate, the treatment contrast cannot be evaluated quantitatively at all. Likewise, an intended outcome or a completed study status does not itself communicate a result.

The record can support a description of study design and planned measurements, but not a conclusion about the magnitude, clinical importance, or statistical significance of a treatment effect. Further outcome results and analysis details are not reported in the registry record.

13. Why This Trial Matters Statistically

Small clinical trials can be statistically informative when their questions, outcomes, and analysis methods are clearly defined and their results are reported with suitable measures of uncertainty. This record is useful for identifying a randomized, triple-masked, placebo-controlled comparison and a short treatment regimen focused on plaque-related assessment in a generally healthy population. It also makes clear that the primary assessment included safety and tolerability domains alongside dental examination.

The statistical challenge is that the registry does not provide the numerical outcome data or any listed analyses. Enrollment is 27, the primary outcome description refers to 26 subjects, and the adverse-event groups each list 13 participants at risk. These details show why the denominator and analysis population should be explicit: they define who contributes to each result and help readers judge its precision. The record does not explain how these populations relate.

The primary outcome encompasses several domains and time points, while a separate outcome describes plaque regrowth using region-specific subscores. Such detail can be valuable, but multiple components need clear definitions and a prespecified way to identify the main comparison. The registry lists 2 outcome measures and 0 analyses and notes that the primary outcome has several categories or time points. It does not report how those comparisons were selected or interpreted.

General statistical context: reporting estimates alongside uncertainty helps distinguish an imprecise result from a precise one and avoids relying on a single significance label. In this record, no treatment estimate, confidence interval, or p-value is available. The statistical importance of the trial therefore lies chiefly in how clearly it illustrates the gap between describing a study design and reporting evidence about its outcomes. Transparent outcome definitions, analysis populations, missing-data methods, and results are necessary for readers to make a meaningful statistical assessment.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation of the registry record is the absence of numerical results for the primary assessment and the plaque-regrowth outcome. The listed outcome descriptions identify examination domains and timing but do not report participant counts for the primary endpoint, plaque scores, or a between-group estimate. No confidence intervals or p-values are reported, and the record lists 0 analyses. The direction, size, and precision of any treatment contrast therefore cannot be assessed.

The primary endpoint description combines safety, tolerability, and effectiveness in its title, while the detailed description focuses on an examination of vital signs and oral surfaces for local, systemic, and serious total-body reactions. The record does not clarify how these domains were combined or which findings constituted the primary event. It also lists a separate plaque-regrowth outcome, without its results. This makes the relationship between the broad primary title and the specific measurement components difficult to interpret.

The registry reports 27 enrolled participants, describes 26 subjects for the primary examination, and lists 13 at risk in each adverse-event group. It does not explain the participant flow, the analysis population, or whether any observations were missing. It also does not report eligibility criteria beyond describing the population as generally healthy, or specify details of the randomization and masking procedures.

Further limitations include the lack of a stated statistical analysis plan, missing-data procedures, multiplicity approach, and explanation of the difference between “KLS-W” in the primary outcome title and “KSL-W” as the intervention name. These gaps limit interpretation of the record; they do not establish that the trial methods were deficient. The registry record does not provide enough information to resolve them.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Is an Antiplaque Chewing Gum (30 mg) Able to Reduce Dental Plaque in a Healthy Population? — NCT02864901.
• Registry record last updated 2025-07-15; status last verified 2025-07.
• Results first posted 2025-07-15.
• 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.

18. Record Summary

NCT02864901 is listed as a completed, randomized, triple-masked, parallel Phase 2 trial sponsored by the U.S. Army Medical Research and Development Command. The registry describes 27 participants enrolled in a study of KSL-W 30 mg chewing gum versus Chewing Gum Placebo, with both regimens taken 3 times per day over 4 treatment days. The population is described as generally healthy.

The primary assessment concerns safety, tolerability, and effectiveness in reducing dental plaque, with baseline and Day 4 timing and an examination of vital signs and oral surfaces. A secondary outcome concerns whole-mouth change in plaque regrowth. The record lists 2 outcome measures and 0 analyses, and does not report numerical primary or plaque-regrowth results.

For each adverse-event group, 13 participants are listed at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. Further details about outcome analyses, missing data, and analysis populations are not reported in the registry record.