Immediate Loading Of Dental Implants: A Pilot Clinical Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Immediate Loading Of Dental Implants: A Pilot Clinical Study (NCT01644058), a na na study. The primary outcome is Patient Satisfaction With the Immediate Loading Protocol.

2. Clinical Question

3. Trial Design

This is a completed, single-group pilot clinical study registered as NCT01644058. The registry lists enrollment as 18 and describes one intervention group, Immediate Loading, receiving immediate loading of 2 endo-osseous mandibular implants. Allocation is listed as NA, and masking is listed as NONE. There is no randomized comparison or like-for-like control group in the record.

The study’s official title specifies immediate loading of dental implants in the mandible full arch and identifies patient satisfaction, quality of life, and implant success as areas of interest. Its brief summary states an objective of providing 2-year clinical- and patient-oriented data for a mandibular overdenture assisted by 2 immediately loaded unsplinted implants. The registry lists 2 outcome measures, but the detailed primary outcome information available in the record concerns patient satisfaction at 4 months.

The registry lists the study start as 2011-06 and primary completion as 2013-03, with status COMPLETED. These dates describe the record’s study timeline; they do not establish when individual outcomes were assessed beyond the stated 4-month primary-outcome timeframe. Further details about procedures, follow-up schedules, participant flow, or how the pilot was conducted are not reported in the registry record.

The design can describe observations in the enrolled group, but without a comparator it cannot isolate the effect of immediate loading from other explanations for observed outcomes. In addition, the registry record does not provide numerical primary-outcome results or analyses. The design and outcome definition are documented, while the results needed to estimate satisfaction and its precision 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

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 Patient Satisfaction With the Immediate Loading Protocol, measured over 4 months.

The primary endpoint is patient satisfaction with the immediate loading protocol, assessed at 4 months using a Visual Analogue Scale. The outcome is continuous: the registry specifies a mean and standard deviation as its summary measures and gives the unit as millimeters. The scale is described as running from 1 to 100, with 100 indicating extreme satisfaction.

A satisfaction measure captures a patient-oriented perspective that may not be represented by clinical measures alone. It can describe how participants rate their experience of the protocol. A mean can summarize the group’s average score, while a standard deviation describes the spread of scores around that average. Those summaries do not, by themselves, show how individual experiences differed or explain why participants gave particular ratings.

The registry record specifies the measure and timeframe but does not report the observed mean, standard deviation, number analyzed, or a confidence interval. Consequently, the actual satisfaction level and the precision of any estimate cannot be assessed from the registry record. The stated score range is a property of the outcome scale, not a result from the study.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean describe?

For a continuous outcome such as a satisfaction score, the mean is the arithmetic average of the observed scores in the analysis group. It gives a single summary of the group’s central level, but it does not show the full distribution. Different sets of participant scores can have the same mean while differing in how widely scores are spread or in whether scores cluster at particular parts of the scale.

The registry specifies the mean as the parameter and the standard deviation as the measure of dispersion for the primary endpoint. In general, the standard deviation describes how spread out individual observations are around the mean. It is not a measure of uncertainty in the mean itself. Uncertainty in an estimated mean is commonly conveyed using a confidence interval, but no confidence interval for this outcome is reported in the registry record.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with the observed data and the assumptions of the interval method. It helps readers judge the precision of an estimate; it is not a range containing most individual participants’ scores. A mean and standard deviation, if available, would describe the group’s scores, while an interval would help describe uncertainty about the mean. Neither the primary-outcome estimate nor its interval is reported in the registry record.

What does the single-group design permit?

A single-group study can describe outcomes among participants who received the intervention. It lacks a concurrent control group for estimating a contrast between treatment strategies. In general, a comparison between groups can help distinguish differences associated with an intervention from changes or influences that may affect both groups. Without such a comparator, this study’s design cannot establish a comparative effect. This remains true even if a group outcome is measured precisely.

Allocation is listed as NA and masking as NONE. These record entries describe the registered design; the registry record does not report a randomized allocation process or a masking procedure. The absence of a separate comparator also means that a between-group treatment estimate cannot be derived from the registered design.

Why does the analysis population matter?

For any outcome, the number of observations used in the analysis and the rules for including participants affect how the result should be interpreted. Enrollment is not necessarily the same as the number with an observed outcome. Participants may have missing measurements or may not meet an analysis rule, but whether that occurred in this study is not reported in the registry record. No analysis population or participant flow for the satisfaction endpoint is specified in the record.

What is the status of the planning assumptions?

The registry record describes a sample-size planning illustration based on a stated fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not observed study results. The record does not report resulting planning values, and it does not report an observed effect for the primary endpoint. The described two-arm planning framework should not be mistaken for the actual single-group study design.

In general, a sample-size calculation uses assumptions about the effect to detect, variability, significance level, and desired power to illustrate a design’s requirements. A planning illustration does not indicate the probability that a particular observed result is correct, and it is not observed power. Because the registry record does not provide the underlying outcome estimate or planning values, no numerical assessment of planning precision is possible.

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("Immediate Loading")
n   <- c(18)
m   <- c(40.3)
sp  <- c(34.9)
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  Immediate Loading  18  40.300  34.900  22.945  57.655

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures and identifies patient satisfaction as the primary outcome. It does not provide a complete account of all outcome definitions, the order in which they were tested, or a statistical analysis plan. The number of analyses is listed as 0. It is therefore not possible to determine whether any multiplicity adjustment was planned or applied, or how multiple outcomes or comparisons were handled.

In general, multiplicity arises when several outcomes, time points, or statistical comparisons are examined. The more opportunities there are to identify a statistically unusual result, the more important it can be to specify which outcome is primary and how other analyses will be interpreted. This general issue does not establish that a particular adjustment was needed or omitted in this study; the registry record does not report the relevant analysis details.

The record does not report the number of participants with observed satisfaction scores, the analysis population, participant flow, or a method for handling missing outcome data. Enrollment is listed as 18, but that does not establish how many contributed to the 4-month endpoint. In general, missingness can affect interpretation when the people with observed measurements differ from those without them. Without counts and methods, the direction or size of any such effect cannot be assessed.

Details about interim analyses, prespecified statistical tests, covariate adjustment, or a missing-data strategy are not reported in the registry record. These absences prevent readers from evaluating whether the posted analysis followed a prespecified plan. Since no primary outcome analysis or numerical result is reported, there is also no basis for assessing model assumptions or the robustness of an estimated effect.

12. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 18 participants at risk in the Immediate Loading group and reports 0 serious adverse events and 0 other adverse events for that group. These figures describe the adverse-event counts in the registry record; they do not establish that no events occurred outside the record’s reporting scope or during any period not captured by the reported information.

The deaths field is null. A null entry is not a reported count of zero, so deaths are not reported in the registry record. The record also lists no serious adverse-event terms. The timeframe and detailed definitions used for adverse-event collection are not reported in the registry record, which limits interpretation of the counts.

In general, an adverse-event count is interpreted in relation to how events were defined, collected, and followed over time. The number at risk gives context for the reported group, but does not explain the completeness of follow-up or whether all participants had the same opportunity for event detection. The registry record does not report those details.

These safety entries should be read as registry-recorded counts, not as proof of absence of risk or as a comparative safety estimate. With no separate control group, the counts cannot show whether event frequency differed from another treatment strategy. They also do not provide a basis for medical advice.

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

The registry record establishes that this was a completed pilot study of immediate loading of 2 endo-osseous mandibular implants in a single group. It identifies patient satisfaction at 4 months as the primary endpoint and describes the Visual Analogue Scale used to assess it. These details clarify the question the study was designed to address.

The record does not report the primary outcome’s observed mean or standard deviation, and it lists 0 analyses. Therefore, it does not show the group’s satisfaction score or the variability in participants’ scores. It also does not report a confidence interval or inferential result that would indicate the precision of an estimate. The score’s range and the description of its upper anchor define how the scale is interpreted; they are not findings.

The design also sets limits on what any group-level observation could establish. There is no separate comparator, so the study cannot directly estimate a difference between immediate loading and another approach. A descriptive result would apply to the studied group and would not, by itself, establish a causal effect or show how the outcome would differ under an alternative strategy.

The study title and brief objective refer to patient-oriented and clinical outcomes over 2 years, while the primary satisfaction measure has a 4-month timeframe. The registry record does not report numerical results for the other outcomes named in the title or a 2-year satisfaction result. Their mention should not be read as evidence that particular findings were observed.

Accordingly, the registered information supports a description of the study’s purpose, intervention, design, and intended primary measure. It does not support a numerical conclusion about satisfaction, comparative benefit, or the precision of an outcome estimate. Missing outcome reporting in the registry record should not be interpreted as a favorable or unfavorable result.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between a registered question and a reported result. The record defines a patient-centered endpoint, its scale, and its assessment timeframe. Those details are necessary to understand what an analysis would represent. However, without the observed mean, standard deviation, or analysis count, the primary outcome cannot be quantitatively evaluated.

The single-group design also illustrates why a clearly measured outcome does not by itself answer a comparative question. An average satisfaction score could describe participants’ reported experience, but a control group would be needed to estimate a direct contrast with another approach. The registry lists allocation as NA and does not describe a comparator.

The record also makes visible the importance of reporting the analysis population and missing-data handling. Enrollment is stated, but the number contributing to the primary endpoint is not reported in the registry record. Without that information, readers cannot establish whether the endpoint summary represents all enrolled participants or a subset.

Finally, the primary endpoint’s patient-oriented nature is distinct from clinical outcomes such as implant success. The official title includes satisfaction, quality of life, and implant success, while the detailed primary measure concerns satisfaction. Keeping these outcomes distinct matters because they answer different questions and may require different summaries and interpretations.

The record thus offers useful context about design and measurement, while illustrating that transparent result reporting is essential for statistical interpretation. A stated objective, scale, and timeframe are not substitutes for an estimate, a measure of uncertainty, and a description of who contributed data.

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 main limitation for interpreting this trial from the registry record is the absence of numerical primary-outcome results. The record specifies patient satisfaction at 4 months but does not report the observed mean, standard deviation, confidence interval, or analysis count. The level and precision of satisfaction therefore cannot be assessed.

The single-group design provides no direct comparison with another treatment strategy. Allocation is listed as NA, and the record identifies no separate control group. Any descriptive outcome would not establish a treatment contrast or distinguish the intervention’s contribution from other influences.

The registry record lists enrollment as 18 but does not report how many participants had a measured primary outcome or how missing measurements were handled. It also does not report participant characteristics that would help readers judge how well the enrolled group represents other populations. Further eligibility and recruitment details are not reported in the registry record.

Although the study objective refers to 2-year clinical- and patient-oriented data, the primary satisfaction endpoint is specified at 4 months. Numerical results for longer-term satisfaction, quality of life, or implant success are not reported in the registry record. The record also does not report the statistical analysis plan, the handling of multiple outcomes, or interim analyses.

For safety, the record reports 0 serious and 0 other adverse events in the Immediate Loading group, but the event-collection timeframe and detailed definitions are not reported in the registry record. The deaths field is null, not a reported zero. These reporting limits should be kept separate from claims about what did or did not occur during the study.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Immediate Loading Of Dental Implants: A Pilot Clinical Study — NCT01644058.
• Registry record last updated 2017-06-02; status last verified 2017-05.
• Results first posted 2014-05-06.
• 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

NCT01644058 is a completed, single-group pilot clinical study titled “Immediate Loading Of Dental Implants: A Pilot Clinical Study.” The registry lists an enrollment of 18, the sponsor as Université de Montréal, a start date of 2011-06, and primary completion in 2013-03. Masking is listed as NONE, and allocation is listed as NA.

The intervention was immediate loading of 2 endo-osseous mandibular implants. The primary outcome was patient satisfaction with the immediate loading protocol at 4 months, measured using a Visual Analogue Scale described as ranging from 1 to 100, with 100 indicating extreme satisfaction.

The registry record does not report a numerical primary-outcome result, and it lists 0 analyses. It reports 0 serious adverse events and 0 other adverse events in the intervention group; deaths are not reported in the registry record. No separate control group is listed.