Immediate Loading and Fully Guided Surgery: Single Implants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Immediate Loading and Fully Guided Surgery: Single Implants (NCT04061694), a non-randomized na study. The primary outcome is Number of Participants With Implant Survival.

2. Clinical Question

The registry describes an evaluation of overall treatment outcomes for single implants placed with fully guided surgery and immediately loaded using restorations made with digital methods. The stated follow-up period was 1 year. The primary outcome was participant count for implant survival at 12 months; the registry definition is based on whether an implant remained in the mouth at examination.

The comparison is between the digital immediate-loading group and a historic immediate-loading cohort. Because allocation was non-randomized and the comparator was historical, differences between groups cannot be attributed to the digital procedure alone from this comparison. The registry record does not report the primary outcome counts, an effect estimate, or a statistical comparison. Thus, the clinical question is clear, but the posted record does not provide the primary results needed to answer it.

3. Trial Design

This was a completed, parallel-group, non-randomized study with no masking. The registry lists enrollment of 46 and identifies the condition as osseointegration failure of a dental implant. The study began in 2016-11, with primary completion in 2019-05. The stated primary outcome timeframe is 12 months.

One group received single implants installed with fully guided surgery and immediate loading, with restorations fabricated using intraoral scanning and 3D printing. The other group was a historic cohort subjected to immediate loading. Although the groups share immediate loading, the registry does not describe the historical cohort as a randomized or contemporaneous control group. Differences in patient selection, clinical practice, follow-up, or other characteristics could therefore affect a group comparison; whether these factors differed is not reported in the registry record.

The registry lists two procedure interventions and five outcome measures, but gives no posted statistical analyses. It does not report the method used to select participants for either group, baseline comparability, details of follow-up completeness, or the planned statistical analysis. The trial status is completed, but that status alone does not establish that every enrolled participant contributed to every outcome.

The study description frames the work as an evaluation of overall treatment outcome using guided surgery, immediate loading, and digital restoration fabrication. The registry record does not report a sample-size justification or state whether any interim analyses were planned or conducted. The non-randomized design is important when interpreting any apparent difference: it provides less protection against confounding than random allocation, and the historic comparator is not a like-for-like control comparison.

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Implant Survival, measured over 12 months.

The primary endpoint is the number of participants with implant survival at 12 months. The registry defines survival as an implant still being in the mouth at examination, regardless of the state of the prosthesis or patient satisfaction. It is therefore a count-based, binary outcome: each participant is classified according to whether the implant meets that definition at the specified assessment.

This endpoint captures whether the implant remains present, but it does not by itself describe the condition or function of the restoration, patient satisfaction, or other aspects of treatment outcome. Those may be relevant dimensions, but the survival definition explicitly does not depend on them. The distinction matters because implant presence and the broader experience or success of treatment are not interchangeable concepts.

As a general statistical point, a clearly defined binary endpoint allows the outcome to be described as counts and proportions, and groups can be compared using methods suitable for binary data. Interpretation still depends on how outcomes were collected, whether participants were followed for the full timeframe, and how missing observations were handled. Those details, along with the primary outcome results, are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods should reflect the outcome being studied, the way participants entered each group, and the completeness and structure of the observations. In this study, the primary endpoint is a participant count for a binary outcome at 12 months. The registry record does not report which method was planned or used to analyze that endpoint. It lists no analyses.

What does a binary endpoint mean?

General explanation: a binary endpoint assigns each participant to one of two outcome categories, such as meeting or not meeting a defined event criterion. The registry’s implant-survival definition is whether an implant remains in the mouth at examination. A complete report would ordinarily make clear how many participants in each group were assessed, how many met the endpoint, and how the comparison was estimated. The primary counts and comparison are not reported in the registry record.

For binary outcomes, statistical summaries can include group counts and proportions, together with a comparative measure and uncertainty interval. Different measures answer somewhat different questions, and the choice should be stated in the analysis plan. No measure or interval for the primary comparison is reported in the registry record, so none can be interpreted for this study.

Why does the design matter?

General explanation: random allocation helps balance measured and unmeasured prognostic factors across groups on average. In a non-randomized comparison, the groups may differ before treatment, and those differences can influence outcomes. A historic cohort adds the possibility that changes over time in patient selection, procedures, clinical practice, or outcome ascertainment affect the comparison. These are general design concerns, not claims that any particular difference occurred in this study. Baseline characteristics, adjustment methods, and cohort-selection details are not reported in the registry record.

Accordingly, a group contrast in this design would be an association unless the analysis and supporting assumptions justified a stronger interpretation. Statistical adjustment may sometimes address measured differences, but it cannot guarantee removal of unmeasured confounding. The registry record does not report whether adjusted analyses were planned or performed.

How should uncertainty be assessed?

General explanation: an estimate describes the observed contrast, while a confidence interval conveys its statistical precision and the range of values compatible with the data under specified assumptions. A narrow interval generally indicates greater precision than a wide one, though precision does not resolve design bias or guarantee that the estimate is unbiased. Neither a primary estimate nor a confidence interval is reported in the registry record.

A p-value, when used, addresses compatibility between the observed data and a specified null model; it is not a measure of clinical importance or the probability that a treatment works. The record lists no analyses and does not provide a p-value for the primary endpoint. Its absence cannot be interpreted as a null finding.

What do the planning illustrations mean?

General explanation: sample-size calculations use assumptions about the effect to detect, the significance level, allocation, and statistical method to illustrate how much information a future study might need. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect expressed as a fraction of the observed effect. Such illustrations are not observed power and are not evidence that the original study had adequate power. The registry record does not report the trial’s own sample-size justification. No planning result should be treated as a trial outcome.

When a planning calculation is based on an observed effect, it is especially important to distinguish the illustration from a prospective design rationale. Observed effects can be uncertain, and planning around them does not establish that a study was designed or analyzed according to those assumptions. The registry does not report a sample-size plan or analysis protocol.

What is not documented?

The record does not report the primary endpoint counts, an analysis population, missing-data procedures, a statistical model, covariate adjustment, or checks of model assumptions. It also does not report an interim-analysis plan. Since no analyses are listed, the statistical methods actually used cannot be reconstructed from the registry record. These gaps prevent assessment of whether the analysis followed a prespecified plan or how robust any comparative result might be.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Digital Immediate Loading", "Immediate Loading")
n      <- c(21, 25)
events <- c(19, 25)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Digital Immediate Loading  21  19  90.5  69.6  98.8  71.1  97.3  70.8  97.1
ARM  Immediate Loading  25  25  100.0  86.3  100.0  86.7  100.0  86.8  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, but does not report a multiplicity strategy or identify a hierarchy for interpreting the outcomes beyond naming implant survival as the primary endpoint. Multiplicity concerns arise when several outcomes or statistical tests are evaluated: repeated testing can increase the chance of at least one apparently notable result. General approaches include prespecifying a primary outcome, adjusting thresholds, or interpreting secondary outcomes as exploratory. Which, if any, approach was used is not reported in the registry record.

The record lists no statistical analyses, and no primary outcome result or inferential comparison is posted. Therefore, the record does not permit evaluation of multiplicity-adjusted or unadjusted findings. The absence of a reported plan should not be read as proof that no plan existed; it means the plan is not reported in the registry record.

Missing-data handling is also not reported. The registry gives enrollment of 46, but does not state how many participants completed the 12-month assessment or contributed to each outcome. It does not describe whether missing observations were excluded, imputed, or handled in another way. These distinctions can affect both the estimate and its uncertainty, particularly if outcome availability is related to participant characteristics or outcomes.

The analysis population is not reported in the registry record. It is therefore unclear whether outcome reporting, if available elsewhere, would include all enrolled participants or a subset defined by treatment received, follow-up, or another criterion. The completed status does not answer these questions. Without the analysis population and missing-data procedures, readers cannot assess the relation between enrollment, follow-up, and the endpoint denominator.

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 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: dental implant loss (9.5%).

The registry reports serious adverse events for two groups. In the Digital Immediate Loading group, 2 of 21 participants were affected; in the Immediate Loading group, 0 of 25 were affected. Dental implant loss is listed among the serious adverse event terms at 9.5%. These are the safety figures posted in the registry record.

These entries should be read as descriptive counts within the listed groups, not as a randomized comparative safety analysis. The study was non-randomized and used a historic cohort, so the groups are not a like-for-like control comparison. The registry record does not provide a comparative estimate, confidence interval, or statistical test for serious adverse events. It also does not report further detail about event timing, severity grading, relatedness assessments, or how events were collected.

Serious adverse events and the primary implant-survival endpoint are different reporting categories. The primary endpoint is defined as implant presence at examination, regardless of prosthesis state or satisfaction. The safety counts should not be used as a replacement for the unreported primary endpoint counts. The listed dental implant loss term is a registry safety entry, and the record does not provide enough additional detail to infer the full course or outcome of every implant.

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

The registry record establishes that the study evaluated digitally guided placement and immediate loading of single implants against a historic immediate-loading cohort, with implant survival at 12 months as the primary endpoint. It also records serious adverse event counts for the two groups. However, it does not report the primary outcome results or any statistical analyses. Consequently, it does not show how many participants met the primary endpoint, how the groups compared on that endpoint, or how precise any estimated difference would be.

The available safety figures are descriptive and arise from a non-randomized comparison. They do not establish a causal effect of the digital procedure, and the listed adverse event term should not be mistaken for a complete analysis of treatment outcome. No interpretation of comparative benefit or harm can be supported by the missing primary results and absent inferential analysis.

More generally, an observed group difference in a non-randomized study may reflect differences in participants, treatment context, follow-up, or other factors. The record does not report sufficient information to determine whether such differences were present or addressed. Even a statistically precise estimate would not, by itself, remove this design limitation.

The study’s completed status and enrollment of 46 describe the registry record but do not demonstrate that all participants were followed or analyzed. The record does not specify missing-data handling or the analysis population. The defensible reading is therefore limited: the study question and design are described, and some serious adverse event counts are posted, but the primary survival result and its uncertainty are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a clinically focused question and a clearly stated endpoint can coexist with important limits in the posted evidence. The primary outcome has an operational definition: an implant is considered surviving if it remains in the mouth at examination, regardless of prosthesis state or patient satisfaction. That definition clarifies what is being counted, while also making clear what the endpoint does not capture.

The comparison highlights the importance of design. A non-randomized intervention group compared with a historic cohort can be useful for describing outcomes in different settings, but it does not provide the same protection against confounding as randomized allocation. The registry explicitly cautions that the arms are not a like-for-like control comparison. That matters when readers consider whether an apparent group difference could be attributed to the digital approach.

The record also illustrates why reporting estimates and uncertainty is essential. Outcome counts alone, even when available, would not fully convey the precision of a comparison; an estimate and interval would help readers understand the range of values compatible with the data. Here, the primary result and analysis are not reported in the registry record, so the clinical question remains unanswered by the posted results.

Finally, the safety entries need to be kept distinct from the primary endpoint. Serious adverse event counts provide a limited descriptive view, but do not substitute for the stated implant-survival outcome or resolve the limitations of the comparison. Together, these features make the study useful for teaching careful separation of endpoint definition, study design, statistical reporting, and interpretation.

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 most consequential limitation for interpreting the registry entry is that the primary implant-survival results are not reported in the registry record. No comparative estimate, confidence interval, or statistical test is posted, and the registry lists no analyses. The study’s central question therefore cannot be answered from these results.

The non-randomized design and historical comparator limit causal interpretation. The registry record does not report how participants entered each group, whether the cohorts were similar at baseline, or whether any adjustment was made for potential confounding. Since the comparator is historical, differences related to time or clinical context could also matter; whether they did is not reported.

Other important details are not reported in the registry record, including the analysis population, the number assessed at 12 months, missing-data procedures, and the statistical analysis plan. The registry lists five outcome measures but does not describe multiplicity handling. Although the study is marked completed, this does not establish complete follow-up or resolve the lack of posted endpoint results.

Safety information is limited to the serious adverse event entries described in the record. Further details about ascertainment, event timing, and relatedness are not reported. The counts are not accompanied by a comparative analysis and should be treated as descriptive rather than conclusive evidence about group differences.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Immediate Loading and Fully Guided Surgery: Single Implants — NCT04061694.
• Registry record last updated 2020-03-31; status last verified 2020-03.
• Results first posted 2020-03-31.
• 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

The registry describes a completed, parallel, non-randomized study of digital immediate loading with fully guided surgery and a historic immediate-loading cohort. Enrollment was 46, and the primary endpoint was the number of participants with implant survival at 12 months.

The primary outcome counts and comparative statistical analyses are not reported in the registry record. Serious adverse events affected 2 of 21 participants in the Digital Immediate Loading group and 0 of 25 in the Immediate Loading group; dental implant loss is listed at 9.5%. Because the comparison was non-randomized and historical, the groups are not a like-for-like control comparison. The posted record describes the study question and limited safety information but does not provide the primary result needed to assess implant survival.