Treatment of Post-Extraction Dehisced Socket - A Case Series Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment of Post-Extraction Dehisced Socket - A Case Series Study (NCT02980211), a na phase 4 study. The primary outcome is Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction.

2. Clinical Question

3. Trial Design

This completed study is registered as a phase 4, single-group case series with an enrollment of 17. The registry lists no allocation and no masking. Everyone in the study arm received treatment of a dehisced extraction socket using a minimally invasive guided bone regeneration technique involving particulate bone allograft and a non-resorbable PTFE membrane. Because there is no separate control arm, the design is descriptive rather than a randomized treatment comparison.

The study focused on people needing extraction of a single-rooted tooth and interested in future implant therapy. A dehiscence defect had to be suspected or confirmed before extraction and then verified after extraction as affecting at least 50% of the bony plate height. The brief description also outlines pre-extraction CBCT imaging, minimally invasive extraction and debridement, membrane placement, grafting, and suturing. It mentions follow-up visits at 1, 2 and 5 weeks to monitor participants, but the available description ends before giving further details of those visits.

The primary outcome was alveolar bone volumetric reduction from baseline to 20 weeks after extraction, assessed using CBCT scans. Although 17 participants were enrolled, two DICOM datasets could not be analyzed because of extensive scattering. The registry therefore states that the final sample size for this outcome was 15. This distinction matters: enrollment describes the number entering the study, while the primary outcome analysis uses the smaller number with analyzable imaging data.

The registry lists the study as completed and gives its start and primary completion dates as 2017-03-01 and 2018-05-03. It lists one outcome measure and no analysis entries. A protocol-level statistical plan, detailed eligibility criteria, and additional analysis procedures 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: Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15

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 Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction, measured over Baseline and 20 weeks post-extraction.

The primary endpoint is alveolar bone volumetric reduction from baseline to 20 weeks after extraction, measured using CBCT scans. It is a continuous outcome expressed in mm3, with the registry specifying a mean and standard deviation. The comparison is within the single study group across the two measurement times; it is not a comparison between treatment arms.

In general, a volumetric measure describes the amount of space occupied by the assessed bone on imaging. Measuring at baseline and again at a stated follow-up time can describe how the measured volume changed over that interval. CBCT is the imaging method named in the registry for this assessment. The endpoint therefore gives a radiographic measure of change in the alveolar bone volume, rather than a direct measure of a participant’s symptoms or later implant outcome.

The registry identifies the endpoint and timeframe but does not report the numerical mean reduction, its standard deviation, or an interval estimate. The reason for choosing this endpoint beyond its role in evaluating bone volume is not reported in the registry record. Two of the 17 DICOM datasets could not be analyzed because of extensive scattering, leaving 15 in the primary outcome sample. That missing imaging information limits how many participants contribute to the endpoint; it does not, by itself, establish the direction or size of any bias.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The outcome is continuous: it measures bone volume in mm3. The registry specifies that the primary summary is a mean with a standard deviation. In general, the mean represents the average measured value in the analysis group, while the standard deviation describes how spread out individual values are around that average. These summaries describe the distribution of measurements; neither, by itself, gives the uncertainty in the estimated mean. The numerical mean and standard deviation are not reported in the registry record.

What does a baseline-to-follow-up measure mean?

The endpoint concerns change between baseline and 20 weeks after extraction. In a general repeated-measure setting, each participant can contribute observations at more than one time. A change score describes the within-participant difference across those times, while a group summary describes the distribution of those changes. The registry calls the outcome volumetric reduction, but it does not state the numerical values or the precise calculation used to derive the reduction. No additional calculation should be inferred from the endpoint label alone.

The primary outcome uses CBCT scans. Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, and the stated final sample for this outcome is 15. This is outcome-specific: the enrollment was 17, but the primary imaging analysis did not include all 17 datasets. In general, missing measurements can affect both precision and representativeness, depending on why data are unavailable and how missingness relates to the outcome. The registry gives the reason for these two unusable datasets, but does not report an imputation method, a missing-data model, or sensitivity analyses.

What can a single-group analysis establish?

The study is listed as a single-group case series with no allocation and no masking. Descriptive summaries can characterize the observed participants and their measurements. A comparison of baseline with follow-up within that group can describe change over time, if the underlying results are available. It cannot, by itself, distinguish a treatment-related change from other explanations for change over time. A separate control group or another design supporting a causal comparison is not described in the registry record.

In general, a confidence interval presents a range of values compatible with an estimate under the assumptions of the analysis method. Its width conveys precision: a wider interval indicates more uncertainty than a narrower one. A p-value addresses a hypothesis test under a specified model and does not measure the size or clinical importance of an effect. The registry record does not report a confidence interval, p-value, or other numerical inferential result for the primary endpoint, and it does not give the statistical model used for that outcome.

How should the planning illustration be read?

The stated planning assumptions describe a hypothetical two-arm calculation: two-sided significance level 0.05, equal allocation between arms, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. The general purpose of such a calculation is to illustrate participant counts under chosen assumptions. Those assumptions do not turn this single-group case series into a two-arm trial, and they do not describe the observed precision or establish the study’s original design rationale. The sample-size justification for the trial is not reported in the registry record. Numerical planning counts are not reported in the registry record.

In general, planning calculations depend on the assumed effect, outcome variability, significance level, allocation, and analysis method. If those assumptions differ from the eventual study or from the observed data, a planning result may not represent the achieved precision. A planning illustration is not observed power and does not replace an estimate with an uncertainty interval. The record does not report interim analyses, a detailed statistical analysis plan, or the analysis population definitions beyond the stated final sample for the primary outcome.

The registry lists one outcome measure and no analysis entries. This indicates that the registry record does not contain a detailed set of statistical results for interpretation. It does not establish what analyses may have been performed outside the information recorded there. No adjustments, covariates, distributional checks, or subgroup analyses are reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Tooth Extraction and Graft Dehisced Socket")
n   <- c(15)
m   <- c(73.26)
sp  <- c(77.27)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Tooth Extraction and Graft Dehisced Socket  15  73.260  77.270  30.469  116.051

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure: alveolar bone volumetric reduction from baseline to 20 weeks after extraction. It does not list analysis entries. The record therefore does not describe a family of multiple primary outcomes or provide a multiplicity adjustment strategy. Whether additional outcomes or analyses were conducted outside the registry record is not reported in the registry record.

For the primary outcome, two of the 17 DICOM datasets could not be analyzed because of extensive scattering. The registry states that 15 participants remained in the final sample for this outcome. This is the only specific account of missing primary outcome data in the record. It does not report whether the two unavailable datasets differed from the analyzed datasets, whether any other outcome data were missing, or whether the missing scans were addressed through imputation or sensitivity analysis.

In general, missing-data methods rely on assumptions about why observations are unavailable and how their values relate to observed data. Without a reported method or information to assess those assumptions, the potential influence of unavailable scans on the estimate cannot be quantified. The record does not specify an intention-to-treat analysis population or other population definitions; the stated outcome sample is 15 because two datasets could not be analyzed. The protocol for handling missing data and the detailed analysis population definitions are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 17 participants at risk for serious adverse events and zero affected by a serious adverse event. It also lists 17 participants at risk for other adverse events and one affected by an other adverse event. The number of deaths is listed as zero. These are counts for the study group, not comparisons between treatment arms.

The record does not identify the other adverse event by term, severity, timing, or relationship to the procedure. The list of serious adverse-event terms is empty. Further details on collection and classification of adverse events are not reported in the registry record. The counts therefore provide only a limited description of what was recorded.

In general, a zero count means that no event of that category was recorded in the stated group during the study’s event ascertainment; it does not establish that the underlying risk is absent. A small case series also has limited ability to characterize uncommon events. These figures should be read as registry counts and not as a comparison of safety with another treatment, since no comparator group is listed.

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

The record establishes that a completed, single-group case series enrolled 17 participants to evaluate a minimally invasive guided bone regeneration approach for dehiscence defects at tooth extraction. The primary outcome was alveolar bone volumetric reduction from baseline to 20 weeks, measured using CBCT. Two datasets could not be analyzed because of extensive scattering, leaving 15 for the primary outcome. These details describe the study and the available outcome sample.

The numerical primary outcome is not reported in the registry record. Thus, the record does not show the mean reduction, its variability, or an interval indicating precision. It is not possible to describe the observed magnitude or direction of the endpoint from the registry information alone. The absence of a numerical result is not evidence that the measured change was either large or small.

Because the study has one group and no stated comparator, it cannot provide a randomized estimate of how the intervention compares with another treatment or no treatment. A within-group change over time, even if its estimate were available, would not alone identify the causal effect of the intervention. The record also does not report a statistical analysis result that would support a formal inferential interpretation.

The adverse-event counts describe zero serious adverse events, one other adverse event, and zero deaths among the 17 participants at risk. The other event is not identified. These counts are useful as a limited account of events in this study, but they do not establish comparative safety or rule out events that were not observed in this group.

In short, the registry gives useful information about the case-series design, treatment approach, endpoint, and analyzable imaging sample. It does not provide the endpoint values needed to assess the amount or precision of bone-volume change, nor a comparison that can support conclusions about relative treatment effects.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of how design and outcome availability shape interpretation. It asks a focused imaging question: how alveolar bone volume changed from baseline to 20 weeks after extraction in participants receiving a graft-and-membrane approach. The registry identifies the endpoint, its unit, and the intended summary as a mean and standard deviation, allowing readers to understand what kind of result would be relevant.

The distinction between enrollment and outcome analysis is important. The study enrolled 17 participants, but extensive scattering prevented analysis of two DICOM datasets, leaving 15 in the primary outcome sample. A reader should therefore not treat the enrollment count as the number contributing to every endpoint. The record also illustrates why the reason for unavailable measurements and the handling of missing data matter to interpretation.

The single-group case-series design sets a clear limit on causal conclusions. Descriptive findings can characterize the treated participants, but a comparison with a separate control group is not available. This design limitation remains even if the endpoint measurement is technically detailed. Likewise, a planning illustration based on hypothetical two-arm assumptions should not be confused with the study’s actual design or with observed statistical evidence.

Finally, the registry’s outcome definition is not a substitute for the result itself. Since the numerical mean, variability, and inferential estimates are not reported in the registry record, readers cannot evaluate the size or precision of the primary finding. The record supports scrutiny of the study structure and data availability, while leaving the central quantitative outcome unresolved.

15. Limitations

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

The primary limitation for interpreting the main question is that the registry record does not report the numerical outcome. It identifies volumetric reduction from baseline to 20 weeks and specifies a mean and standard deviation, but gives neither value. No confidence interval or hypothesis-test result is listed. The observed magnitude and precision of the endpoint therefore cannot be assessed from this record.

The study is a single-group case series, with no allocation to a comparator and no masking. This means it cannot directly estimate a comparative treatment effect. Any change observed over time would be a description of the treated group and would not by itself separate the intervention’s contribution from other influences. The registry does not describe a control condition.

Two of the 17 DICOM datasets were unusable because of extensive scattering, leaving 15 participants for the primary outcome. The reason is stated, but the record does not report whether the missing measurements could be related to participant characteristics or outcome values, or how missing data were treated analytically. This limits assessment of the potential effect of missing imaging data.

The registry provides limited statistical-method detail. A detailed analysis plan, analysis population definitions beyond the outcome sample, confidence-interval method, distributional assessments, and sensitivity analyses are not reported in the registry record. The nature of the one other adverse event is also not described. These gaps restrict interpretation of both efficacy-related measurements and safety counts.

Eligibility was focused on single-rooted teeth and substantial dehiscence defects in people interested in future implant therapy. Findings from this selected case series, even if numerical results were available, would not automatically describe other populations or settings. The record does not give enough information to assess how broadly the enrolled participants represent other patients with extraction sockets.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Treatment of Post-Extraction Dehisced Socket - A Case Series Study — NCT02980211.
• Registry record last updated 2020-02-05; status last verified 2020-01.
• Results first posted 2020-01-22.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT02980211 is a completed phase 4, single-group case series with 17 participants. It evaluated treatment of post-extraction dehiscence defects using a minimally invasive guided bone regeneration technique with particulate bone allograft and a non-resorbable PTFE membrane. The registry lists no allocation and no masking.

The primary outcome was alveolar bone volumetric reduction from baseline to 20 weeks after extraction, measured by CBCT in mm3 and summarized as a mean with standard deviation. Two of the 17 DICOM datasets could not be analyzed because of extensive scattering, leaving 15 in the primary outcome sample. The numerical outcome result and its uncertainty are not reported in the registry record.

The registry lists zero serious adverse events among 17 participants, one other adverse event among 17, and zero deaths. The other event is not identified. No analysis entries are listed, and a detailed statistical analysis plan and missing-data methods are not reported in the registry record.