This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Periodontal Infection and Endothelial Dysfunction (NCT00681564), a randomized phase 3 study. The primary outcome is Brachial Artery Flow-mediated Dilation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00681564 |
| Phase | Phase 3 |
| Condition | Periodontitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 102 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Universidad del Valle, Colombia |
| Results posted | Yes |
2. Clinical Question
Population
People with periodontitis were enrolled. The registry lists enrollment of 102. It does not report further eligibility details or describe participant characteristics in the record. The primary outcome description refers to assessments of vascular function, including a baseline measurement and follow-up after periodontal therapy.
Intervention
The experimental intervention was One-Stage Full-Mouth Disinfection. Its description includes scaling and root planing in four quadrants in one session, tongue brushing with chlorhexidine gel, mouth rinsing with chlorhexidine solution, and subgingival chlorhexidine irrigation. It also lists twice-daily chlorhexidine rinsing; the duration wording at the end of that description is incomplete in the registry record.
Comparator
The active comparator was periodontal care, described as basic oral hygiene instructions and supragingival plaque removal. The registry names this group Periodontal Prophylaxis in its safety information. The record does not give further detail about the frequency or delivery of this care.
Primary question
The stated primary question concerns whether periodontal therapy is associated with a change in endothelium-dependent brachial artery flow-mediated dilation, measured at baseline and after therapy. The listed assessment times are baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. Numerical results for these measurements, including the comparison between groups, are not reported in the registry record.
In statistical terms, the trial targets a vascular-function measure rather than a clinical cardiovascular event. Flow-mediated dilation is expressed as a percentage change in brachial artery diameter following cuff release. The registry describes the primary outcome as a difference in this measure at baseline and three months after randomization, while the outcome timeframe separately lists the assessment at 12 weeks. The record does not clarify how the three listed assessments contributed to the primary analysis or identify one reported between-group estimate. The clinical question can therefore be described from the design and endpoint definition, but the magnitude and precision of any treatment contrast cannot be judged from the registry record.
3. Trial Design
The registry describes a completed phase 3 study with randomized allocation, double masking, and a parallel design. Enrollment is listed as 102. The sponsor is Universidad del Valle, Colombia. The listed start is 2008-05, and primary completion is listed as 2011-03. The condition is periodontitis. The registry does not give additional detail about the randomization procedure, how masking was implemented or maintained, or how participants were assigned to the two interventions.
The experimental arm received One-Stage Full-Mouth Disinfection, while the active comparator arm received periodontal care. The former is described as an intensive oral intervention involving scaling and root planing, chlorhexidine use in several forms, and additional rinsing. The comparator is described more briefly as basic oral hygiene instructions and supragingival plaque removal. The duration wording for the experimental arm's final rinsing instruction is incomplete in the registry record, and the record does not specify how often the comparator procedures were delivered.
The primary endpoint was brachial artery flow-mediated dilation, with assessments listed at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. The primary outcome text also describes a difference between baseline and three months after randomization. The record lists secondary outcomes covering inflammatory markers, cholesterol measures, white blood cell count, subgingival microbiota, and vascular adhesion molecules. It reports 12 outcome measures and 3 analyses, but does not explain how those counts map to specific hypotheses or analysis sets.
Although the study is marked completed, numerical efficacy results for the primary endpoint are not reported in the registry record. The record also does not provide a participant flow account, the numbers analyzed for each endpoint, or a detailed statistical analysis plan. The design establishes the intended comparison, but those missing details limit assessment of execution and interpretation.
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: Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2).
Overall Study
| Stage | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| STARTED | 47 | 55 |
| COMPLETED | 41 | 47 |
| NOT COMPLETED | 6 | 8 |
Reasons for not completing this period:
| Reason | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|
| Lost to Follow-up | 6 | 6 |
| Withdrawal by Subject | 0 | 1 |
| Death | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.
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.
| Characteristic | Unit | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) | Total |
|---|---|---|---|---|
| Participants analysed | 47 | 55 | 102 | |
| Age, Continuous | years | 45.5 (SD 9.4) | 45.5 (SD 8.1) | 45.5 (SD 6.9) |
| Sex: Female, Male: Female | Participants | 24 | 30 | 54 |
| Sex: Female, Male: Male | Participants | 23 | 25 | 48 |
| Race/Ethnicity, Customized: White | participants | 6 | 5 | 11 |
| Race/Ethnicity, Customized: Black | participants | 5 | 5 | 10 |
| Race/Ethnicity, Customized: Indian | participants | 0 | 3 | 3 |
| Race/Ethnicity, Customized: Mixed ethnicity | participants | 36 | 42 | 78 |
| Smoking status: Currently smoking | participants | 12 | 14 | 26 |
| Smoking status: Never smoker | participants | 24 | 28 | 52 |
| Smoking status: Former smoker | participants | 11 | 13 | 24 |
| Formal education: Elementary education (1 to 5 years) | participants | 14 | 17 | 31 |
| Formal education: Secondary education (6 to 11 years) | participants | 22 | 25 | 47 |
| Formal education: Higher education (12 or more years) | participants | 11 | 13 | 24 |
| Family monthly income: Less than $300 USD | participants | 19 | 23 | 42 |
| Family monthly income: ≥ $300 and ≤ $600 USD | participants | 24 | 22 | 46 |
| Family monthly income: More than $600 USD | participants | 4 | 10 | 14 |
| Medical insurance: None | participants | 5 | 5 | 10 |
| Medical insurance: State-subsidized healthcare | participants | 30 | 34 | 64 |
| Medical insurance: Contributory regime (private insurance) | participants | 11 | 15 | 26 |
| Medical insurance: Prepaid medicine plan | participants | 1 | 1 | 2 |
| Endothelium-dependent brachial artery flow-mediated dilatation | Percentage of dilation | 9.9 (SD 7.4) | 9.9 (SD 8.5) | 9.9 (SD 7.9) |
| Serum C-reactive protein (CRP) | mg/L | 4 (SD 7) | 3.1 (SD 3.6) | 3.6 (SD 5.4) |
6. Primary Endpoint
The registry lists the primary outcome as Brachial Artery Flow-mediated Dilation, measured over Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage of dilatation of brachial art |
| Endpoint classification | Continuous Endpoint |
Brachial artery flow-mediated dilation, abbreviated FMD in the registry description, measures endothelium-dependent vasodilatation. The endpoint is based on the change in brachial artery diameter after a cuff is released, expressed as a percentage relative to the baseline diameter. The stated unit is percentage of dilatation of the brachial artery. The registry says that diameter was measured 45-60 s after cuff release and identifies a published technique and guidelines, without providing additional procedural details in the record.
As general statistical and physiological context, flow-mediated dilation is used as a noninvasive measure of vascular endothelial function. A change in this measure can indicate a difference in the measured vascular response under the assessment conditions; it is not itself a count of cardiovascular events or a direct measure of long-term clinical outcomes. The endpoint is continuous, and the registry describes its summary as a mean with standard deviation. A mean describes the average observed measurement, while a standard deviation describes variability among measurements.
The assessments were scheduled at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. Vascular assessments were performed in the morning in a temperature-controlled room, with participants required to fast for at least 8 hours. Such standardized conditions are relevant because measurement conditions can influence observed vascular responses. The registry does not report the endpoint values, their variability, or an estimate comparing treatment groups. It is therefore possible to describe what was measured and why it serves as a vascular-function endpoint, but not to characterize the size or precision of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial question and primary endpoint but does not report numerical results for brachial artery flow-mediated dilation. There is no posted mean, standard deviation, change from baseline, between-group contrast, confidence interval, or p-value for the primary endpoint in the registry record recorded. Consequently, the direction, magnitude, and statistical precision of the primary comparison are not available for interpretation. The trial's completed status does not substitute for outcome estimates.
The outcome timeframe includes baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. The primary outcome description also refers to a difference between baseline and three months after randomization. Without the reported outcome values or a clear explanation of how time points were incorporated into the primary analysis, it is not possible to determine whether the intended comparison was a change within each group, a difference in changes between groups, or another contrast. These are different statistical questions and should not be treated as interchangeable.
The primary endpoint is continuous. For such an endpoint, a useful interpretation would ordinarily consider the estimated difference between randomized groups, its uncertainty, and the scale of the measurement. A confidence interval, if reported, would show a range of values compatible with the data and analysis under the method's assumptions. A p-value alone would not describe the magnitude of the contrast or how precisely it was estimated. Neither type of result is reported in the registry record for the primary outcome.
Several secondary outcomes are named, including high-sensitivity C-Reactive Protein, total cholesterol, white blood cell count, subgingival microbiota, LDL cholesterol, E-selectin, ICAM-1, and VCAM-1. Their names indicate the range of biomarkers under study, but names alone do not establish whether any measure changed or whether any contrast was precise. Numerical secondary-outcome results and their uncertainty are not reported in the registry record.
The safety listing records serious adverse events in the intervention groups, including 0 serious events in the experimental group and 1 in the active comparator group. The registry also lists motor vehicle traffic accident with a frequency of 1.8%. These sparse safety counts should be read as descriptive registry entries, not as a comparison establishing that one intervention is safer. The record does not provide enough detail about event attribution, timing, or the full adverse-event ascertainment process to support a broader safety interpretation.
Overall, the available record supports a description of the planned randomized comparison and endpoint, but not a conclusion about the size or direction of the primary result. Any interpretation of benefit, lack of benefit, or clinical relevance would require outcome estimates and uncertainty that are not reported in the registry record. The missing results are an evidentiary limitation, not evidence that the interventions had identical effects.
9. Statistical Methods Explained
The registry identifies a randomized, double-masked, parallel design. Random allocation is intended to create groups that are comparable on average at the start of a trial, reducing the risk that differences in measured or unmeasured participant characteristics explain later group differences. Masking is intended to limit influences on care, measurement, or assessment that could arise when treatment assignment is known. These are general design principles. The registry record does not describe the allocation sequence, concealment procedures, who was masked, or how masking was maintained, so those implementation details cannot be evaluated.
What kind of outcome was measured?
The primary outcome is continuous: flow-mediated dilation is reported as a percentage measure. For a continuous endpoint, a common summary is the mean, which represents the average measurement in a group, together with a standard deviation, which describes the spread of individual observations around that average. The registry lists mean and standard deviation as the parameter and dispersion. However, it does not give the actual means or standard deviations for the primary endpoint. Without those values, an unadjusted difference cannot be recalculated, and the amount of variability cannot be assessed.
A treatment comparison for repeated measurements may focus on change from baseline, the follow-up value adjusted for baseline, or a difference between groups in their changes. These approaches answer related but not identical questions and can use information differently. This is general statistical context, not a claim about the analysis used in this trial. The registry mentions a primary outcome difference between baseline and three months after randomization and lists measurements at baseline, 24 hours, and 12 weeks, but the precise contrast and model are not reported in the registry record.
Why might different tests be named?
The primary outcome description says that the primary outcome and secondary outcomes were analyzed using the Kruskal-Wallis test and unpaired t test, depending on the distribution. An unpaired t test is a general method for comparing group means when its assumptions are considered suitable. The Kruskal-Wallis test is a rank-based method for comparing distributions across groups and may be considered when assumptions for a mean-based comparison are not appropriate. These tests do not automatically estimate the same quantity: a t test is directly framed around means, while a rank-based test operates on the ordering of observations. The registry does not say which test was used for each outcome, how distributional suitability was assessed, or whether the analysis was adjusted for baseline values.
For repeated measurements, the method also needs to account for the fact that observations from the same participant are related. General methods for repeated data can model that dependence rather than treating every measurement as independent. The registry record does not state whether such a method was used. The presence of multiple time points makes this detail important: a separate test at each time point, a within-person change analysis, and a model using all repeated observations can produce estimates with different interpretations and uncertainty.
How should uncertainty be read?
A confidence interval gives a range of estimates that are compatible with the observed data under a specified statistical method and its assumptions. Its width reflects precision: wider intervals generally indicate less precision, while narrower intervals indicate more. A point estimate without an interval can obscure substantial uncertainty. A p-value addresses compatibility between the data and a specified null hypothesis under the analysis assumptions; it does not tell readers how large an effect is, whether it matters clinically, or whether the assumptions are credible. No primary-outcome confidence interval or p-value is reported in the registry record.
Distributional assumptions matter because a statistical test's behavior depends on whether its model is a reasonable representation of the data. Skewed measurements, outliers, or unequal variability can affect mean-based procedures. Rank-based procedures avoid some assumptions about the numerical shape of a distribution, but they have their own interpretation and assumptions. The registry says test selection depended on distribution, but does not report diagnostic procedures, transformations, robust methods, or a prespecified decision rule. It is therefore not possible to determine how the choice between tests was made.
What do the planning assumptions mean?
The registry describes sample-size calculations as planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. These assumptions describe hypothetical planning scenarios; they do not report the trial's original sample-size justification and do not establish the trial's statistical power after the fact. Sample-size illustrations are not observed power. Their interpretation depends on the effect used as the planning basis, the chosen fraction, and the assumptions stated for the calculation. The actual numerical sample-size illustrations are not reported in the registry record.
More generally, planning calculations estimate how much information a future design might need to detect an effect under chosen assumptions. They do not show that the effect is real, and they do not replace an estimate and confidence interval from the trial itself. A calculation based on an observed effect can also be sensitive to the uncertainty in that observed estimate. The record does not report the values needed to assess these planning scenarios independently.
What can be inferred from the named analyses?
The record reports 3 analyses and 12 outcome measures, but does not provide a detailed statistical plan or map each analysis to a specific endpoint, time point, or population. It does not state whether analyses were prespecified, whether results were adjusted for baseline variables, or how missing measurements were handled. No recalculated treatment estimate is appropriate because the primary endpoint summaries are not reported. The sponsor's own analysis cannot be compared with an independent recalculation from the available primary-outcome information.
Thus, the methods named in the record provide limited information about the intended statistical approach. They identify candidate tests and a general condition for choosing between them, but they do not document the full analysis pathway. Interpretation would be stronger with the exact estimand, the analysis population, the handling of repeated observations and missing data, and the estimated group contrast with its uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary vascular-function outcome and a broad set of secondary outcomes, and reports 12 outcome measures and 3 analyses. Assessing several outcomes or time points can increase the chance that at least one result appears noteworthy by chance if each is tested separately. This is the general issue of multiplicity. Possible approaches include identifying a single primary contrast, organizing outcomes hierarchically, or adjusting inference across a defined family of tests. The registry record does not report a multiplicity strategy, identify a hierarchy for the secondary outcomes, or specify which comparisons were confirmatory.
Because the primary endpoint has assessments at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy, the definition of the primary comparison is especially relevant. The record does not say whether all time points were analyzed, whether one follow-up time was primary, or how any repeated-time comparisons were handled. It also does not report whether secondary outcomes were examined at multiple time points. No conclusion about the extent of multiplicity adjustment can be drawn from the named tests alone.
Missing-data handling is not reported in the registry record. There is no reported participant flow by assessment, number of unavailable measurements, reason for missingness, or method for addressing missing outcomes. General methods may include analyses based on available observations, imputation, or models that use incomplete repeated data, but these methods rely on assumptions and should be described rather than presumed. The record also does not state the analysis population, such as whether participants were analyzed according to randomized assignment or only if they completed treatment or follow-up.
These omissions limit assessment of whether the reported analyses, if any, preserve the advantages of randomization and appropriately reflect uncertainty. They also make it difficult to determine whether results across outcomes and time points were selectively emphasized. The numerical efficacy results and these analysis details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Periodontal Intervention (Experimental) | 0 | 47 | 0.0% |
| Periodontal Prophylaxis (Active Comparator) | 1 | 55 | 1.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Periodontal Intervention (Experimental) | 47 of 47 |
| Periodontal Prophylaxis (Active Comparator) | 31 of 55 |
Most frequent serious adverse event terms
| Event term | Organ system | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|---|
| Motor vehicle traffic accident | Social circumstances | 0 of 47 | 1 of 55 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Periodontal Intervention (Experimental) | Periodontal Prophylaxis (Active Comparator) |
|---|---|---|---|
| Swelling | Surgical and medical procedures | 47 of 47 | 28 of 55 |
| Gingival erythema or bleeding | Surgical and medical procedures | 46 of 47 | 24 of 55 |
| Periodontal pain (low-intensity) | Surgical and medical procedures | 36 of 47 | 18 of 55 |
Serious events with the highest arm-level rate: motor vehicle traffic accident (1.8%).
The safety record lists 47 participants at risk for serious adverse events in the experimental periodontal intervention group and 55 in the active comparator group. It records 0 serious events in the experimental group and 1 in the comparator group. The registry's listed top serious-event term is motor vehicle traffic accident, with a reported frequency of 1.8%. The record does not explicitly connect that term to a particular group in the registry record, so it should not be assigned to one based on inference.
These entries are counts, not a complete characterization of safety. With sparse serious-event counts, descriptive differences can be highly uncertain and are not, by themselves, evidence of a treatment-related difference. The registry record does not report event timing, investigator judgments about relatedness, severity details beyond the serious-event classification, or whether all events were actively solicited. Death counts are not reported in the registry record.
The safety entries should therefore be read narrowly: they describe what the registry lists for serious adverse events and identify a named event term, but do not establish cause or comparative risk. The record does not give the broader context needed to evaluate non-serious adverse events or the completeness of safety follow-up. These limitations are separate from the absence of numerical primary efficacy results.
12. What the Result Does, and Does Not, Mean
The trial record describes a randomized comparison of One-Stage Full-Mouth Disinfection with periodontal care among people with periodontitis. Its primary endpoint is brachial artery flow-mediated dilation, a continuous measure of endothelium-dependent vascular function. Assessments are listed at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. This information establishes the topic and intended measurement, but it does not establish what the comparison found.
The primary outcome estimates are not reported in the registry record. No numerical change, between-group difference, confidence interval, or p-value is available for interpretation. It is therefore not possible to determine the direction or magnitude of the observed effect, or how precisely it was estimated. The lack of a reported result must not be interpreted as evidence that there was no difference. It also does not justify claiming that either intervention changed endothelial function.
Even when reported, a difference in a vascular-function measure would need to be interpreted in relation to the measurement scale, uncertainty, timing, and analysis method. A statistical difference is not automatically a clinically important difference, and a biomarker or physiological endpoint is not the same as a clinical cardiovascular outcome. The registry names additional biomarkers, but numerical results for them are also not reported in the registry record. No inference about cardiovascular events or long-term health outcomes follows from the endpoint name alone.
The safety information is similarly limited. The registry records 0 serious events in the experimental group and 1 in the comparator group, and lists motor vehicle traffic accident at 1.8%. Those entries do not identify causation or support a reliable comparative safety conclusion without fuller event and follow-up information. Overall, the record supports a cautious description of the study design, interventions, endpoint, and listed safety counts. It does not provide the efficacy results or analytical detail needed to judge the effect of periodontal therapy on the primary endpoint.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it asks whether an intensive periodontal intervention is associated with a change in a vascular-function measure. The study uses a randomized, double-masked, parallel design, and the primary endpoint is a continuous physiological measure rather than a clinical event. That combination raises familiar questions about baseline comparability, repeated measurement, endpoint definition, and how the treatment contrast should be estimated.
The endpoint is listed at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. Multiple time points can help distinguish an early measurement from a later follow-up, but they also require a clear analysis plan. A comparison at one time point, a change from baseline, and a comparison of changes are different estimands. The registry record does not clarify which contrast was used or how the repeated observations were handled. This makes the missing analysis detail consequential for interpreting any result.
The registry also names several secondary biomarkers. When a study evaluates multiple outcomes, readers need to know which comparisons were primary and how multiplicity was addressed. Without that information, a pattern of results across measures can be difficult to interpret, particularly when no numerical estimates or uncertainty are reported. The problem is not that multiple outcomes are inherently inappropriate; it is that their intended roles and inferential treatment should be transparent.
Finally, the record illustrates the distinction between registration information and a complete results report. It documents a completed trial and a defined question, but the primary-outcome results needed to assess effect size and precision are not reported in the registry record. A trial's design can be informative even when its numerical findings are unavailable, but it cannot substitute for them. The statistical importance of this study therefore lies both in its repeated-measures question and in the reporting details required to make that question answerable.
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 most important limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. The mean, standard deviation, treatment contrast, uncertainty interval, and p-value are unavailable. The same limitation applies to the named secondary outcomes. As a result, the magnitude and precision of the trial's findings cannot be assessed from this record.
The record lists baseline, 24-hour, and 12-week assessments, while its primary outcome description refers to a difference between baseline and three months after randomization. It does not explain how those descriptions align in the primary analysis, whether the outcome was analyzed as a change, or which follow-up contrast was primary. The analysis methods are described only as using Kruskal-Wallis and unpaired t tests depending on distribution. The record does not specify which test was used for each outcome, how distributional assumptions were assessed, or how repeated measurements were handled.
Participant flow and analysis-population details are not reported in the registry record. The number of participants with observed measurements at each time point, reasons for missing data, and methods for handling missingness are unavailable. The record also does not describe the randomization sequence or concealment, who was masked, or whether masking was maintained. These omissions prevent assessment of important features of trial conduct and analysis.
The experimental intervention description ends with incomplete duration wording for its final rinsing instruction. The comparator description gives only basic oral hygiene instructions and supragingival plaque removal, with no further delivery details. The record does not report the multiplicity strategy for the several listed outcomes, nor does it provide a detailed statistical analysis plan. Safety information is limited to serious-event entries and does not give full ascertainment, timing, or relatedness details. These are limitations of the registry record; they should not be filled in by assumption.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Periodontal Infection and Endothelial Dysfunction — NCT00681564.
- Registry record last updated 2014-04-17; status last verified 2014-03.
- Results first posted 2014-04-01.
- 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.
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18. Record Summary
NCT00681564, titled “Periodontal Infection and Endothelial Dysfunction,” is listed as a completed phase 3, randomized, double-masked, parallel study sponsored by Universidad del Valle, Colombia. The registry lists enrollment of 102 and periodontitis as the condition. The experimental intervention was One-Stage Full-Mouth Disinfection; the active comparator was periodontal care.
The primary outcome was brachial artery flow-mediated dilation, a continuous measure reported as a percentage of dilatation. Assessments were listed at baseline, 24 hours post periodontal therapy, and 12 weeks post periodontal therapy. Secondary outcomes included inflammatory markers, cholesterol measures, white blood cell count, subgingival microbiota, and vascular adhesion molecules. The registry reports 12 outcome measures and 3 analyses.
Numerical primary and secondary outcome results are not reported in the registry record. The analysis description names Kruskal-Wallis and unpaired t tests, depending on distribution, but does not provide a detailed analysis plan. Serious-event entries list 0 events in the experimental group and 1 in the active comparator group; the record does not provide enough information to infer comparative safety or event causation.