A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading. (NCT00728962), a registered phase not stated study. The primary outcome is Patients With Implants Achieving Osseous Integration.

2. Clinical Question

The study asked whether patients receiving Osseotite Certain Prevail implants for short-span fixed restorations achieved osseous integration after immediate occlusal loading. The registry defines integration success as an implant showing no signs of mobility at the time of analysis, with the primary endpoint assessed at 1 year. It describes a temporary prosthesis being used until the final prosthesis is made.

Population. The registry lists 75 enrolled participants and identifies partial edentulism and tooth disease as the conditions of interest. The detailed eligibility criteria, baseline characteristics, and clinical setting for individual participants are not reported in the registry record.

Intervention. Participants received Osseotite Certain Prevail implant(s), intended to support a short fixed bridge with immediate occlusal loading. The registry describes the device and treatment approach but does not report further details of surgical technique, loading procedures, or prosthesis management.

Comparator. There was no concurrent control group. The registry states that results would be compared with performance of other Osseotite implants from published multicenter studies. The specific external studies, their results, and the method for making that comparison are not reported in the registry record.

Primary question. The primary outcome was the number of patients achieving osseous integration, defined by absence of implant mobility, at 1 year. The primary outcome result is not reported in the registry record. The record therefore describes the question and endpoint but does not establish how many participants met the success definition.

3. Trial Design

This was a prospective, multicenter, observational study of Osseotite Certain Prevail implants used for immediate occlusal loading of short-span fixed restorations. The registry lists the study as completed and records enrollment of 75 participants. The recorded start was 2005-03, and primary completion was 2006-05. The sponsor is ZimVie.

Because the study was observational and had no concurrent control group, it did not randomize participants between the implant strategy and a comparison treatment. Allocation is not stated in the registry record. The registry describes comparison with performance data from other Osseotite multicenter studies, but does not identify those studies or provide a prespecified concurrent comparator. Any comparison with external evidence would therefore need to account for differences in participants, clinical practice, outcome definitions, and follow-up; how those issues were handled is not reported in the registry record.

The primary endpoint was a participant count: patients whose implant(s) showed no signs of mobility at the time of analysis, with the outcome timeframe listed as 1 year. The registry identifies crestal bone regression as the secondary outcome. It records two outcome measures in total, but does not report the secondary outcome result. The primary analysis population is described as the total number of patients enrolled in the study.

The registry does not report the number of participating centers, the detailed eligibility criteria, the planned enrollment rationale, or a statistical analysis plan. It also does not report whether assessments were blinded, how loss to follow-up was handled, or whether any interim analyses were planned. These omissions limit what can be reconstructed about conduct and analysis from the registry record alone.

4. Participant Flow and Accounting

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

Before assignment: Pre-treatment included a screening visit(enroll those meeting all study inclusion criteria), signing informed consent, and pre-surgical data collection. Within 48hrs., impressions of the patient's treatment areas are taken for making a temporary prosthesis. Patients are then scheduled for implant placement surgery.

Implant Placement Surgery

Reasons for not completing this period:

Permanent Prosthesis Placement

Reasons for not completing this period:

One Year post placement follow-up

Two Year post placement follow-up

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: total number of patients enrolled in the study was used for primary outcome analysis

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 Patients With Implants Achieving Osseous Integration, measured over 1 year.

The primary endpoint counts participants whose implant(s) achieved osseous integration, defined in the registry as showing no signs of mobility at the time of analysis. The outcome timeframe is 1 year. This definition makes the endpoint a binary participant-level measure: each participant is assessed against the success criterion, and the outcome can be represented as a count of participants meeting it. The registry says the total number enrolled was used for the primary outcome analysis.

In general, a clearly defined endpoint helps distinguish the clinical event being assessed from broader judgments about treatment performance. Here, absence of mobility is the specific criterion stated for integration success. The endpoint does not, by itself, describe every aspect of implant or restoration performance, and the registry does not define it as a measure of comfort, function, or long-term durability. Those should not be inferred from this outcome definition.

The registry record does not report the number of participants who met the integration criterion. It therefore does not provide the primary outcome count or an estimate of the proportion with success. The timeframe is specified, but the record does not clarify the exact assessment process or how participants without an evaluable 1-year assessment were treated. The secondary outcome, crestal bone regression, is named but its measurement method and result are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The endpoint is a binary participant outcome: a patient either meets the registry's stated integration-success criterion or does not. The criterion is that the implant shows no signs of mobility at the time of analysis. In general, binary outcomes are commonly summarized as event counts and denominators, with an estimated proportion sometimes used to describe the frequency of the outcome. The registry record gives the enrollment count and names the endpoint, but does not report the number meeting the criterion. No success proportion can therefore be stated from the registry information.

What does the endpoint count?

The primary measure is worded as the number of patients with implants achieving osseous integration. The registry says the total number of patients enrolled was used for primary outcome analysis. This indicates a participant-level count in the stated analysis population; it does not supply the observed count. The registry also does not clarify whether every participant had one implant or multiple implants, or how outcomes were summarized if a participant received more than one implant. The endpoint description refers to implant(s), but the detailed counting rules are not reported in the registry record.

What would uncertainty estimates mean?

In general, a confidence interval expresses statistical uncertainty around an estimate. For a binary outcome, an interval around an observed proportion reflects both the observed event count and the number of participants assessed, as well as the method used to construct the interval. A narrow interval generally indicates more precision than a wide interval, while neither interval alone resolves limitations in study design or measurement. The registry record does not report an observed primary endpoint count, a confidence interval, or the method used for an interval calculation.

A p-value, in general, measures how compatible observed data are with a specified statistical null model. It does not give the probability that a treatment works, nor does it measure the clinical importance of an effect. Since the registry record reports no primary analysis, it provides no p-value or stated inferential test for the endpoint. The study description also refers to no concurrent control group, so a treatment-versus-control hypothesis test is not described.

Why does the study design affect inference?

In general, random allocation can help make groups comparable with respect to measured and unmeasured characteristics, while an observational design does not create that protection through randomization. Here, the registry identifies a prospective observational design and no concurrent control group. It mentions comparison with other Osseotite implant studies, but the studies, their participant characteristics, and the comparison method are not reported in the registry record. Differences between separate studies can reflect more than the treatment strategy, so an external comparison requires careful methods and cautious interpretation.

The registry calls the study multicenter, but does not report the number of centers or whether outcomes were analyzed with methods accounting for center-level differences. In general, outcomes from participants at the same center may be more similar than outcomes from participants at different centers. If that clustering is present, analyses that treat all observations as independent may understate uncertainty. Whether clustering was relevant or addressed in this study is not reported in the registry record.

What do planning illustrations convey?

Sample-size calculations are planning tools that describe the number of participants or events that would be needed under specified assumptions. They are not observed power, and they do not establish what the study could detect after the data have been collected. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of the observed effect. These are illustrative assumptions, not a description of the actual observational design, which had no concurrent control group. The sample-size justification used when planning the study is not reported in the registry record.

In general, power depends on factors including the assumed effect, outcome variability, sample size, and analysis method. For binary endpoints, the event frequency is also relevant. Planning based on an observed effect can be particularly uncertain because the observed estimate may be imprecise. Any such planning figures should be read as conditional illustrations rather than as proof that the study had adequate power or that a null result would be informative. The registry does not report its original target sample size rationale or statistical plan.

What can be said about the posted analyses?

The registry lists no analyses. It therefore does not provide an analytic model, adjustment variables, confidence intervals, or hypothesis-test results for the primary endpoint. The result for crestal bone regression is also not reported. The definition of the endpoint and the stated analysis population can be described, but a reader cannot assess how the endpoint was analyzed beyond those recorded details. If the sponsor's own analysis and a simple recalculation from posted summary statistics were ever to disagree, the sponsor's own analysis takes precedence; however, the registry record does not report a primary analysis to compare with a recalculation.

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("Osseotite Certain Prevail Implant")
n      <- c(75)
events <- c(59)
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  Osseotite Certain Prevail Implant  75  59  78.7  67.7  87.3  68.1  86.4  68.1  86.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the primary endpoint of patients with implants achieving osseous integration and the secondary outcome of crestal bone regression. It does not report a multiplicity plan, such as whether any adjustment was planned for evaluating more than one outcome. Multiplicity concerns arise in general when several statistical tests are conducted, because the chance of at least one apparently notable result can increase as more tests are considered. The registry record lists no analyses, so it does not establish how many tests, if any, were performed or what inferential approach was used.

The primary analysis population is described as the total number of patients enrolled. The enrollment was 75. That statement does not establish that all 75 participants had outcome data at 1 year. The registry does not report the number with completed follow-up, the number with missing endpoint assessments, reasons for missingness, or how any missing values were handled. These details are not reported in the registry record.

In general, missing outcome data can affect both the estimated event frequency and its precision. The direction and size of any effect depend on why observations are missing and on the outcomes among participants without assessments. No assumptions about missingness can be verified from the registry information. The record also does not report whether the analysis population was modified after enrollment or whether any participants were excluded from the primary analysis.

The registry's stated analysis population is therefore useful context, but it is not a substitute for a participant flow account or outcome-availability information. It is not possible to determine from the record whether the primary analysis included every enrolled participant with complete follow-up, used another approach, or had a different evaluable denominator.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists the Osseotite Certain Prevail Implant group with 75 participants at risk for serious adverse events and 0 affected. For other adverse events, it lists 75 at risk and 11 affected. These are event-category counts as recorded, not comparative estimates against another treatment group. The study had no concurrent control group.

The registry lists no terms among the top serious adverse event terms. It does not report the nature, timing, severity, or relatedness of the 11 other adverse events in the information described. The mortality field is not reported in the registry record. The counts should therefore be read as limited descriptive safety information rather than a complete account of all clinical events or evidence about comparative safety.

In general, an at-risk count identifies the population recorded as eligible for a given event category; it does not, by itself, show the duration or completeness of safety follow-up. The record does not provide the safety observation period or detailed rules for collecting and classifying events. It also does not show whether participants could contribute more than one event to the other-adverse-event count. Those details are not reported in the registry record.

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

The registry record describes a prospective, multicenter observational study of immediate occlusal loading with Osseotite Certain Prevail implants. It specifies a primary endpoint: the number of patients whose implant(s) showed no signs of mobility at 1 year. It also records enrollment of 75 participants and names crestal bone regression as a secondary outcome. These details clarify what the study was intended to evaluate.

The record does not report the number of participants meeting the primary endpoint, the result for crestal bone regression, or any primary analysis. It therefore does not support a statement about the observed frequency of integration success or the precision of that result. In general, a defined endpoint is not the same as an observed result, and enrollment alone cannot establish the endpoint outcome.

The study also does not provide a concurrent control group. Its stated intention to compare results with other Osseotite multicenter studies does not, on its own, establish that the groups or study conditions were comparable. The external studies and comparison methods are not reported in the registry record. Accordingly, the registry description cannot establish a causal difference between immediate occlusal loading and another approach.

The safety entries show 0 serious adverse events among 75 at risk and 11 other adverse events among 75 at risk in the implant group. Those descriptive counts do not provide a comparative risk estimate, and the record does not describe the events in sufficient detail to characterize them. The listed counts should not be extended beyond the categories and information recorded.

Overall, the registry supports a description of the intended question, design, and limited recorded safety counts. It does not provide the primary efficacy result, inferential statistics, missing-data information, or a concurrent comparison. The absence of a reported result is not evidence that the endpoint was met or not met; it marks a limitation in what can be concluded from the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable because it illustrates the distinction between a clearly named endpoint and a reported result. The registry specifies a participant count based on absence of implant mobility at 1 year, yet does not report the number of participants meeting that criterion. Without the endpoint count, a reader cannot estimate the observed frequency or quantify its precision from the registry record.

The design also matters. A prospective observational study can describe outcomes in a defined setting, but without a concurrent control group it does not provide a randomized comparison. The registry's reference to other Osseotite multicenter studies signals an intended external comparison, but the studies and comparison procedure are not identified. That makes it impossible to assess whether differences between the study populations or methods were addressed.

The record names a secondary outcome and provides limited adverse-event counts, but does not report outcome analyses, missingness, or a statistical plan. These omissions matter because interpretation depends not only on endpoint definitions but also on who was assessed, how observations were handled, and how estimates were calculated. The available information supports description of the study's framework, not a complete statistical evaluation of its results.

The planning assumptions also demonstrate why hypothetical sample-size calculations should not be confused with the design actually used. Equal allocation between two arms is part of the stated illustration assumptions, whereas the registry describes a single observational group with no concurrent control. Planning figures under hypothetical conditions do not establish the study's observed power, nor do they replace the unreported sample-size rationale.

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.

Several limitations are specific to the registry information for this study. First, the primary outcome result is not reported in the registry record, despite a defined endpoint and a stated 1-year timeframe. The number of participants assessed at that timeframe, the number meeting the integration criterion, and any uncertainty estimates are also not reported. This prevents quantitative interpretation of the primary endpoint.

Second, the observational design had no concurrent control group. The registry mentions comparison with other Osseotite multicenter studies but does not identify those studies or explain how their results would be compared. It is therefore not possible to evaluate comparability or understand any adjustment for differences across studies.

Third, the registry does not report detailed participant characteristics, eligibility criteria, number of centers, assessment procedures, or the handling of participants with multiple implants. These omissions make it harder to judge how broadly the enrolled population and endpoint definition can be interpreted. Follow-up completeness and missing-data handling are also not reported in the registry record.

Finally, the registry does not provide the study's statistical analysis plan, sample-size justification, or analyses for either the primary or secondary outcome. The safety entries do not include event descriptions, timing, relatedness, or a reported mortality count. These limits are distinct from whether the study was completed: completion status is recorded, but completion alone does not supply the missing outcome and analysis details.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading. — NCT00728962.
• Registry record last updated 2026-07-28; status last verified 2022-03.
• Results first posted 2010-02-05.
• 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 identifies NCT00728962 as a completed prospective, multicenter observational study of Osseotite Certain Prevail implants used to support short fixed bridges with immediate occlusal loading. Enrollment was 75. The recorded start was 2005-03, and primary completion was 2006-05. ZimVie is listed as the sponsor.

The primary outcome was patients with implants achieving osseous integration, defined as no signs of mobility at 1 year. The registry states that the total enrolled population was used for primary outcome analysis. It names crestal bone regression as the secondary outcome. Neither outcome result nor any analysis is reported in the registry record.

The study had no concurrent control group. The registry describes a planned comparison with other Osseotite multicenter studies but does not give details of those studies or the comparison method. The implant group safety entries list 0 serious adverse events and 11 other adverse events, with 75 at risk for each category. The registry record does not provide further event details or a reported mortality count.