EMD and/or Bone Substitute for the Treatment of Class II Furcations: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for EMD and/or Bone Substitute for the Treatment of Class II Furcations (NCT02474498), a randomized phase 4 study. The primary outcome is Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months.

2. Clinical Question

The trial evaluates a continuous periodontal measurement recorded in millimetres. RHCAL is measured at a specified buccal furcation site using a periodontal probe and an individualized acrylic stent as a reference. The clinical question is therefore about the observed average measurement in each treatment arm and the estimated difference between arms, not simply whether an individual defect improved or worsened.

The registry describes the study as a randomized, parallel-group clinical trial with single masking. It lists three treatment arms and gives results at the 12-month time point for the primary endpoint. The posted results permit a comparison of the group means and an assessment of statistical uncertainty, but do not provide a detailed account of participant characteristics, allocation procedures, or the population included in each analysis. Those details are not reported in the registry record.

The comparison is not a direct test of every possible treatment pairing. The posted primary comparisons contrast each active arm with βTCP/HA alone. The question is thus whether the observed 12-month mean RHCAL differs between the reference arm and either EMD-containing approach, while keeping in mind the modest arm sizes and the uncertainty around each estimated difference.

3. Trial Design

The registry lists a phase 4 randomized clinical trial using a parallel design. Participants were assigned to treatment arms, with each arm receiving a distinct approach involving flap access surgery and one or both study materials. The listed arms are βTCP/HA alone, βTCP/HA plus EMD, and EMD alone. The study status is completed, and the registry reports enrollment of 41.

The intervention descriptions indicate that flap access surgery was part of the treatment approach. They describe removal of granulation tissue and instrumentation of root surfaces, followed by application of the assigned material or combination. The arm descriptions in the registry record are truncated, so details not visible in those descriptions cannot be established from this record. Randomization is reported, but the method used to generate or conceal allocation is not reported in the registry record.

Masking is listed as single. The registry record does not say which people were masked, how masking was maintained, or whether assessment of the clinical endpoint was masked. It would therefore be inappropriate to infer whether participants, clinicians, assessors, or analysts were unaware of assignment.

The primary endpoint was assessed at 12 months. The registry also lists three secondary clinical measures, each at 12 months: relative vertical clinical attachment level, periodontal probing depth, and relative gingival margin position. Posted arm results are available for the primary and secondary measures. The registry does not report the study’s original sample-size justification, detailed analysis populations, handling of missing observations, or a prespecified statistical analysis plan. Those limitations affect how fully the posted comparisons can be interpreted, particularly given that several outcomes and treatment comparisons are presented.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Potential patients were selected from those referred to the Graduate Clinic of the Piracicaba Dental School. All patients received a complete periodontal examination, including anamnesis, a full-mouth periodontal probing, and radiographic examination. One furcation defect per patient was chosen, using Nabers probe.

6. Primary Endpoint

The registry lists the primary outcome as Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months, measured over 12 months.

The primary endpoint is relative horizontal clinical attachment level (RHCAL) at 12 months, reported as a mean in millimetres with a standard deviation in each arm. The measurement is taken at one specified buccal furcation site. A periodontal probe is introduced horizontally into the furcation, and the distance from the deepest point reached by the probe to the lower border of an individually manufactured acrylic stent is recorded. The site is identified by a groove in the stent, and the reading is recorded to the nearest 0.5 mm.

This endpoint provides a continuous measure of the horizontal clinical attachment level at the furcation entrance. A continuous measure retains more gradation than a simple category such as improved or not improved, allowing the trial results to describe the distribution of measurements through means and standard deviations. Comparing arm means gives an estimate of the average difference at the specified follow-up time.

Clinical interpretation depends on the measurement’s definition and the direction of its scale. The posted values describe the recorded distance, but the registry does not provide a threshold for a clinically important difference or a statement that a particular numerical direction constitutes a better outcome. Statistical evidence about a difference should therefore be separated from a claim about clinical importance. The endpoint also reflects a measurement at a defined site and time; it does not by itself describe all aspects of periodontal health or longer-term outcomes.

7. Results Posted in the Registry

• βTCP/HA + EMD: mean 3.00 versus 2.31 on control; difference 0.69 (95% CI 0.02 to 1.36), standardized effect d = 0.76; z-test p = 0.044.
• EMD Alone: mean 2.57 versus 2.31 on control; difference 0.26 (95% CI -0.38 to 0.90), standardized effect d = 0.31; z-test p = 0.429.

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.

Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months

• 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:
  • EMD + βTCP/HA: mean 12.36 versus 12.31 on control; difference 0.05 (95% CI -1.02 to 1.12), standardized effect d = 0.03; z-test p = 0.927.
  • EMD Alone: mean 11.93 versus 12.31 on control; difference -0.38 (95% CI -1.38 to 0.62), standardized effect d = -0.29; z-test p = 0.456.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between EMD + βTCP/HA 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 EMD Alone and the control. The interval gives the range of effects that remain compatible with the data.

Periodontal Probing Depth at 12 Months

• 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:
  • βTCP/HA Alone: mean 2.57 versus 2.38 on control; difference 0.19 (95% CI -0.34 to 0.72), standardized effect d = 0.27; z-test p = 0.484.
  • EMD + βTCP/HA: mean 2.36 versus 2.38 on control; difference -0.02 (95% CI -0.69 to 0.65), standardized effect d = -0.02; z-test p = 0.953.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between βTCP/HA Alone 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 EMD + βTCP/HA and the control. The interval gives the range of effects that remain compatible with the data.

Relative Gingival Margin Position (RGMP) at 12 Months

• 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:
  • βTCP/HA Alone: mean 9.79 versus 9.92 on control; difference -0.13 (95% CI -0.98 to 0.72), standardized effect d = -0.12; z-test p = 0.763.
  • EMD + βTCP/HA: mean 9.57 versus 9.92 on control; difference -0.35 (95% CI -1.16 to 0.46), standardized effect d = -0.33; z-test p = 0.397.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between βTCP/HA Alone 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 EMD + βTCP/HA and the control. The interval gives the range of effects that remain compatible with the data.

The secondary measures cover related but distinct aspects of periodontal status: relative vertical clinical attachment level, probing depth, and gingival margin position. Across their posted group means, the comparisons do not present a uniform pattern in which the same treatment consistently separates from βTCP/HA alone across all measures. The estimated differences are generally modest relative to their uncertainty, and the comparison intervals include zero.

This broad pattern gives context to the primary result. The primary comparison involving the combination treatment has an interval just above zero, while the secondary comparisons do not show a similarly clear separation. That does not invalidate the primary estimate, but it means the secondary outcomes do not supply a strong, consistent signal that independently reinforces it. Nor does the absence of clear secondary differences demonstrate that the treatments have identical effects.

Secondary outcomes often help characterize whether a result is specific to one measurement or appears across related measures. Here, however, each outcome is another opportunity to observe a difference, and multiple treatment contrasts are also posted. Without a reported multiplicity strategy, the chance of at least one small unadjusted p-value across a collection of comparisons is greater than for a single prespecified test. The registry record does not report whether the investigators designated a hierarchy of outcomes or adjusted inference accordingly.

For that reason, secondary results carry less confirmatory weight than a prespecified, fully documented primary analysis. The registry identifies the primary endpoint, but does not provide enough detail about the analysis plan to establish the full inferential hierarchy. The secondary pattern is best treated as descriptive context: it neither clearly corroborates nor clearly contradicts the primary comparison, and the uncertainty leaves room for effects that the posted sample sizes cannot resolve precisely.

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

• Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
• Periodontal Probing Depth at 12 Months
• Relative Gingival Margin Position (RGMP) at 12 Months

9. Statistical Interpretation

10. Statistical Methods Explained

The posted outcomes are continuous measures summarized by an arm mean and standard deviation. A mean describes the central value of measurements in an arm, while the standard deviation describes how spread out individual measurements are around that mean. These summaries convey different information: a similar mean can occur alongside different amounts of variability, and a difference in means must be considered in light of both variability and the number of observations.

What does a mean difference represent?

For each posted comparison, the estimated mean difference contrasts the non-reference arm with βTCP/HA alone. A positive estimate indicates that the first arm’s posted mean is numerically higher; a negative estimate indicates that it is lower. The estimate is in the endpoint’s unit, millimetres. It is an average contrast between groups, not a difference that should be expected for every participant. Nor does its sign alone establish whether the measured direction is clinically preferable.

The primary comparison of βTCP/HA plus EMD with βTCP/HA alone has an estimated mean difference of 0.69 mm. For EMD alone compared with βTCP/HA alone, the estimate is 0.26 mm. The confidence interval expresses uncertainty around each estimated contrast. If an interval includes zero, the observed data are compatible with no mean difference as well as with differences in either direction within the interval. An interval that excludes zero indicates that the range of estimates supported by that particular interval does not include no difference, but does not establish clinical importance or resolve the consequences of multiple comparisons.

How should the p-values be read?

A p-value assesses how compatible the observed data are with a specified null model of no difference, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The primary comparison p-values are unadjusted: 0.044 for the combination versus βTCP/HA alone and 0.429 for EMD alone versus βTCP/HA alone. Since the registry does not report adjustment for multiple comparisons, these should not be interpreted as multiplicity-adjusted evidence.

The registry reports the mean differences and intervals, but does not report a detailed statistical analysis plan or the model used for the sponsor’s primary analysis. No reported analyses are listed for the secondary outcomes. The comparison calculations presented with the posted summaries should therefore be understood as unadjusted comparisons, not as a substitute for a fully documented trial analysis. The registry record does not describe covariate adjustment, repeated-measures methods, or how departures from model assumptions were handled.

Why do spread and sample size matter?

Sampling variability depends on the spread of measurements and the number of observations. Greater within-arm variability tends to make an estimated mean difference less precise, while more observations can improve precision. The arm standard deviations for the primary measure range from 0.75 to 1.04 mm, and the posted arm counts are 14, 14, and 13. With arm sizes of this scale, the uncertainty around a mean difference can remain substantial, as reflected in the confidence intervals.

These ideas are general statistical principles. They do not establish that the trial met any particular assumptions. The registry does not report diagnostic checks, distributional assessments, or information on influential observations. Since this endpoint is continuous, the posted summaries support mean-based comparisons, but without fuller methods information it is not possible to assess the robustness of the analysis to the data distribution or other modeling choices.

What role do the secondary outcomes play?

The secondary measures broaden the description of the trial beyond horizontal attachment level. They cover relative vertical clinical attachment level, periodontal probing depth, and relative gingival margin position at 12 months. Each is summarized with group means and standard deviations, and the posted comparisons are also unadjusted. General statistical reasoning cautions that evaluating multiple outcomes and contrasts creates more opportunities for an apparently unusual result. Whether or how the investigators addressed this issue is not reported in the registry record.

Across the secondary results, the intervals are broad relative to the point estimates and include zero. This pattern indicates limited precision for distinguishing arm means, rather than proof of equivalence. Secondary measures can help assess whether the primary result is accompanied by a coherent pattern across related clinical dimensions, but they should not be treated as independent validation when the multiplicity strategy and analysis plan are not reported.

11. Confidence Intervals and Precision

Confidence intervals communicate the range of effect estimates reasonably compatible with the data and the assumptions used to calculate the interval. They are more informative about precision than a p-value alone because they show both the direction and the range of plausible differences. A narrow interval indicates a more precise estimate; a wide interval indicates greater uncertainty. Neither width nor exclusion of zero determines whether a difference matters clinically.

For the primary comparison of βTCP/HA plus EMD with βTCP/HA alone, the mean difference is 0.69 mm, and the 95% confidence interval extends from 0.018 to 1.362 mm. The lower limit is close to zero, while the upper limit allows a substantially larger positive difference. The estimate therefore has limited precision despite the interval excluding zero. The unadjusted p-value of 0.044 should be read alongside this range, rather than as a standalone verdict.

For EMD alone compared with βTCP/HA alone, the mean difference is 0.26 mm, with an interval from -0.385 to 0.905 mm. The interval crosses zero and spans negative and positive values. Thus, the posted summary is compatible with a lower mean, little or no difference, or a higher mean for EMD alone relative to the reference arm. It does not establish that the groups are equivalent.

Both primary intervals are based on relatively small arm counts, and the registry does not post confidence limits for the arm means themselves. More importantly, it does not state a clinically meaningful difference for RHCAL. Statistical precision can be described from the intervals, but the clinical importance of the range cannot be determined from the registry record alone. The posted estimates also concern the 12-month assessment and do not characterize longer-term uncertainty.

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 illustrations give participants per arm for 80% power and participants per arm for 90% power. They are not total sample sizes. The calculations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

For the primary comparison of βTCP/HA plus EMD with βTCP/HA alone, the illustration based on 100% of the observed effect lists 28 participants per arm for 80% power and 37 participants per arm for 90% power. Planning for 75% of the observed effect lists 49 participants per arm for 80% power and 65 participants per arm for 90% power. Planning for 50% lists 109 participants per arm for 80% power and 146 participants per arm for 90% power.

For the EMD-alone comparison, the corresponding figures are 167 and 223 participants per arm for 100% of the observed effect, 296 and 397 for 75%, and 666 and 892 for 50%. These are illustrations based on the observed estimates and variability, not the original design plan. Smaller effects require more participants to detect under the stated assumptions.

The 80% and 90% columns describe the probability of detecting the specified effect under the planning assumptions if that effect is present; a higher target probability generally requires a larger planned sample. This is not observed power. These calculations are sensitive to the observed effect estimates, which may be unstable in a small trial, and should be read as planning aids rather than evidence that the study was adequately or inadequately designed.

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 = 0.690; pooled standard deviation σ = 0.907.
2. n = 2 × (1.96 + 0.842)² × 0.907² / 0.690² = 27.1, rounded up to 28 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 <- 0.69                      # observed difference in means
sigma <- 0.906669730386981                     # 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(2474498)
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 = 28 (80% power), 37 (90% power)
 75% of observed effect: n per arm = 49 (80% power), 65 (90% power)
 50% of observed effect: n per arm = 109 (80% power), 146 (90% power)
power.t.test: 28.1 
Simulated power at n = 28 per arm: 0.797 (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. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint and three secondary endpoints, with treatment comparisons reported for each. Considering several outcomes and contrasts raises a multiplicity issue: even when no true differences exist, repeated testing can make one or more apparently notable results more likely by chance. This is a general statistical concern, not evidence that the posted result is spurious. The registry record does not report whether the investigators adjusted for multiple testing, specified a testing hierarchy, or treated secondary outcomes as exploratory.

The primary comparison with an unadjusted p-value of 0.044 should therefore be interpreted as a nominal result. The record does not state whether that p-value was the sole primary test in a prespecified confirmatory plan or how it relates to other planned contrasts. The sponsor’s own analysis takes precedence when a discrepancy is reported; no discrepancy is indicated in the registry record, but the record still does not supply the full analysis plan needed to evaluate multiplicity handling.

Missing-data details are also not reported in the registry record. Although arm counts and endpoint summaries are posted, there is no stated flow of participants through follow-up, no account of missing measurements, and no description of imputation or other missing-data methods. It is therefore not possible to determine from the record whether every randomized participant contributed to each endpoint or whether the posted summaries use another analysis population.

The registry does not describe an intention-to-treat, per-protocol, or safety analysis population, nor does it state how participants were handled if they did not receive their assigned approach or complete follow-up. These omissions do not prove that the analyses were inappropriate, but they prevent assessment of whether the posted comparisons preserve randomization or how sensitive they may be to missingness and analysis-population choices.

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

The posted results describe average clinical measurements at 12 months in three randomized treatment arms. They show a positive estimated mean RHCAL difference for βTCP/HA plus EMD compared with βTCP/HA alone, with a 95% confidence interval that narrowly excludes zero, and a less precise estimated difference for EMD alone compared with βTCP/HA alone, with an interval that includes zero. These are statistical descriptions of the recorded measurements; they are not, by themselves, evidence that a treatment is clinically better or worse.

The registry does not give a threshold for a clinically meaningful RHCAL difference. It also does not explain the clinical interpretation of higher versus lower values on the measurement scale. Statistical evidence that two group means differ and evidence that the difference matters to patients or clinicians are separate questions. The posted summary addresses the former more directly than the latter.

A confidence interval crossing zero does not demonstrate no effect, and a confidence interval excluding zero does not demonstrate a clinically important effect. The arm sizes and interval widths indicate that estimates remain uncertain. The results do not establish equivalence among the three approaches, nor do they determine what would happen for an individual patient or in populations not described by the record.

The findings are limited to the 12-month measures listed in the registry. They do not describe durability beyond that time point, other clinical outcomes, or longer-term harms. The adverse-event record lists zero participants at risk for serious and other adverse-event summaries in each arm, while deaths are not reported. Those entries do not support a conclusion that no adverse events occurred: the registry record does not explain why the reported risk counts are zero or provide interpretable event follow-up details.

In short, the record offers a small set of observed arm means and unadjusted comparisons, with uncertainty that remains important to interpretation. It does not provide enough information to make broad claims about clinical benefit, harm, equivalence, or safety.

16. Why This Trial Matters Statistically

This trial is statistically instructive because it separates an observed difference from the certainty and meaning of that difference. The primary comparison for the combination treatment has an estimated mean contrast whose interval only narrowly excludes zero. A binary reading of the p-value would miss how close the interval comes to no difference and how much larger effects remain compatible with the data. The other primary comparison illustrates the complementary case: a non-small p-value and an interval spanning zero do not prove equal treatment effects.

The study also illustrates how modest arm sizes constrain precision. Mean differences can be estimated from continuous outcomes, but the uncertainty depends on variability as well as the number of observations. The posted secondary estimates and intervals show why a pattern across outcomes matters, while also demonstrating why several unadjusted comparisons should not be treated as a collection of independent confirmations.

The planning illustrations connect observed effects to prospective sample-size thinking, but they are not the trial’s original rationale and do not measure the study’s observed power. Their wide variation across assumed effect fractions shows the sensitivity of sample-size planning to the effect one intends to detect. A planning calculation based on an observed effect from a small study may be particularly uncertain as a guide for future work.

Finally, the record highlights the importance of transparent reporting. Information about analysis populations, missing measurements, multiplicity, and the specific masking procedures would make it easier to distinguish a robust confirmatory result from a descriptive signal. The numerical findings can be interpreted, but the scope of inference is constrained by what the registry record reports.

17. 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.

Several limitations are specific to the information available for this trial. The registry reports enrollment of 41, while the endpoint arm counts are 14, 14, and 13. It does not provide participant flow or clarify whether these counts represent all randomized participants, participants assessed at 12 months, or another analysis population. Missing observations and their handling are not reported.

The record identifies the trial as single masked but does not state who was masked or how. Allocation concealment and the randomization method are also not described. The arm descriptions are truncated, limiting the treatment-procedure detail that can be confirmed from the record. These are reporting limitations; they do not establish that the underlying trial procedures were deficient.

The primary and secondary summaries provide group means and standard deviations, but the registry does not report a detailed analysis plan, adjustment for baseline measurements or other covariates, diagnostic checks, or multiplicity handling. The posted secondary outcomes have no reported analyses listed beyond the summary comparisons. Consequently, it is difficult to assess whether the posted comparisons match a prespecified analysis or how robust the findings are to analytic choices.

The adverse-event record shows zero participants at risk for the listed adverse-event summaries in each arm, and deaths are not reported. The record does not explain these entries or provide enough detail to characterize safety follow-up. Finally, all reported outcomes are at 12 months, and the record does not provide a clinically important difference for the primary measurement. These omissions limit interpretation of both clinical relevance and longer-term outcomes.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: EMD and/or Bone Substitute for the Treatment of Class II Furcations — NCT02474498.
• Registry record last updated 2017-03-20; status last verified 2015-06.
• Results first posted 2017-03-20.
• 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.

21. Record Summary

NCT02474498 is a completed, randomized, parallel-group phase 4 trial sponsored by the University of Campinas, Brazil. It enrolled 41 participants and compared βTCP/HA alone, EMD alone, and βTCP/HA plus EMD for mandibular class II buccal furcation defects. The registry lists single masking and a primary assessment at 12 months.

The primary endpoint was mean relative horizontal clinical attachment level. The posted combination-versus-βTCP/HA comparison has a mean difference of 0.69 mm, a 95% confidence interval from 0.018 to 1.362, and an unadjusted p-value of 0.044. The EMD-alone comparison has a mean difference of 0.26 mm, a 95% confidence interval from -0.385 to 0.905, and an unadjusted p-value of 0.429.

Three secondary clinical measures are also reported at 12 months. The registry does not report the original sample-size justification, detailed analysis populations, missing-data handling, or multiplicity procedures. The numerical findings should therefore be interpreted with their uncertainty and the record’s reporting limitations in view.