This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population (NCT01389258), a na na study. The primary outcome is Implant Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01389258 |
| Phase | NA |
| Condition | Partially Edentulous Jaw |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Dentsply Sirona Implants and Consumables |
| Results posted | Yes |
2. Clinical Question
The study asks whether OsseoSpeed™ TX narrow implants, with a diameter of 3 mm, remain in place at the 3-year follow-up after loading in a Chinese population. The primary outcome is implant survival, evaluated clinically and radiographically. The registry record also lists implant stability, marginal bone level alteration and measures of peri-implant mucosal condition.
Population
Participants with a partially edentulous jaw who received at least one implant. The registry describes an intention-to-treat population of 45 subjects and 47 implants.
Intervention
OsseoSpeed™ TX narrow implants, 3 mm in diameter and 11–15 mm in length.
Comparator
There is no separate comparator group. The study is recorded as a single-group study without a randomized allocation.
Primary question
How many implants survived to the 3-year follow-up visit after loading, based on clinical and radiographic evaluation?
The registry record describes a Chinese population and identifies the study as prospective, open and multi-center. Its official title refers to the anterior maxilla, while the brief summary refers to the posterior maxilla. That difference in location wording is not resolved in the record. The record does not report a numerical survival result, so the question is clear but its answer cannot be quantified from the posted information.
3. Trial Design
This is a prospective, open, multi-center, single-group study of the OsseoSpeed™ TX 3 mm implant. The registry lists 45 participants enrolled and a completed study. The recorded start is 2011-06, and primary completion is recorded as 2014-08. No randomized allocation or masking is recorded; masking is listed as none. The study is not a comparison between two assigned treatment groups.
The intervention is described as narrow implants with a diameter of 3 mm and lengths of 11–15 mm. The study population is described as Chinese participants with a partially edentulous jaw. The official title specifies the anterior maxilla, whereas the brief summary refers to the posterior maxilla. The registry record does not explain this difference in anatomical wording.
The primary outcome is implant survival assessed clinically and radiographically at the 3-year follow-up visit after loading. The registry describes the intention-to-treat population as all participants who received at least one implant: 45 subjects and 47 implants. It also states that 5 subjects, with 5 implants, had been lost to follow-up at the 3-year visit, and identifies 40 subjects and 42 implants as the basis for a subsequent description. That description ends before clarifying the exact outcome denominator or result.
The record lists secondary outcomes concerning implant stability, marginal bone level alteration, probing pocket depth, bleeding on probing, plaque and gingival zenith score. The registry record does not report a comparator, a protocol-based sample-size justification, or the statistical analysis plan. It also reports no statistical analyses or numerical primary outcome results. The study design therefore supports description of outcomes in one enrolled group, but does not provide a randomized between-group estimate.
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
| Stage | OsseoSpeed™ TX |
|---|---|
| STARTED | 45 |
| COMPLETED | 40 |
| NOT COMPLETED | 5 |
Reasons for not completing this period:
| Reason | OsseoSpeed™ TX |
|---|---|
| Lost to Follow-up | 5 |
Analysis population for the primary outcome, as defined in the registry: Intention to treat (ITT), including all participants that received at least one implant, a total of 45 subjects (47 implants). A total of 5 subjects (5 implants) had been lost to follow-up at time of the 3-year follow-up visit, giving an overall number of 40 subjects (42 implants) as basis for the analysis of three year survival rate.
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.
| Characteristic | Unit | OsseoSpeed™ TX |
|---|---|---|
| Participants analysed | 45 | |
| Age, Continuous | years | 36.4 (SD 14.50) |
| Sex: Female, Male: Female | Participants | 24 |
| Sex: Female, Male: Male | Participants | 21 |
| Region of Enrollment: China | participants | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Implant Survival, measured over Measured at the 3-year follow-up visit after implant loading..
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Implants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is implant survival, expressed as a count of implants and evaluated clinically and radiographically at the 3-year follow-up visit after loading. The registry record defines the assessed unit as implants, while also describing the population in terms of subjects. This distinction matters because a participant could receive more than one implant: the record reports 45 subjects and 47 implants in the intention-to-treat population.
In general, survival is used to describe whether a device remains in place at a specified follow-up assessment. Clinical and radiographic evaluation provides the stated basis for judging survival in this study. This endpoint is distinct from the listed measures of implant stability, marginal bone change and peri-implant tissue condition; those outcomes describe other aspects of the implant or surrounding tissues.
The record gives the assessment time but does not provide a numerical survival count, survival rate, confidence interval or statistical test. It reports that 5 subjects and 5 implants were lost to follow-up by the 3-year visit, and mentions 40 subjects and 42 implants as the basis for a subsequent statement that is incomplete in the registry record. The precise denominator used for the primary endpoint is therefore not fully specified in the available description. Without the result and a clearly stated analysis denominator, the endpoint’s magnitude and precision cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically and radiographically assessed implant-survival endpoint at the 3-year follow-up after loading. It does not report the number of implants that survived, a survival rate, or an uncertainty interval. Consequently, the posted information does not establish the observed level of survival or how precisely it was estimated. The study’s stated purpose and hypothesis are not substitutes for outcome results.
The study is a single-group study, not a randomized comparison. Its findings, if numerical results were available, would describe outcomes among the enrolled participants and implants under the study conditions. They could not by themselves establish how those outcomes compare with another implant, another treatment strategy or an untreated group. The registry’s allocation and masking entries confirm that there is no recorded randomized allocation or masking. The study’s open design is relevant context when interpreting outcomes involving clinical assessment, although the record does not specify how assessors were organized or whether assessments were independently reviewed.
The population description requires care. The record identifies 45 subjects and 47 implants in its intention-to-treat description. It also reports that 5 subjects and 5 implants were lost to follow-up at the 3-year visit, then gives 40 subjects and 42 implants as a basis for a statement that ends incomplete. These details indicate that follow-up was not complete for every enrolled subject and implant. The exact primary-outcome denominator and the handling of missing follow-up information are not reported in the registry record.
The record reports no statistical analyses. It therefore gives no confidence interval, hypothesis test, adjusted estimate or other measure of sampling uncertainty for the primary outcome. In general, a confidence interval communicates a range of values compatible with the observed data under the method used; without a reported estimate and interval, precision cannot be judged. No statistical significance claim can be evaluated from the registry information.
The registry lists secondary outcomes related to stability, bone-level alteration and peri-implant tissue condition, but does not report numerical results for them. The record’s stated hypothesis concerns early loading as a safe and predictable procedure, but the listed primary outcome and absent numerical results do not allow that hypothesis to be assessed from this record alone. No conclusion about comparative performance or treatment effect is warranted from the information reported.
9. Statistical Methods Explained
The registry record describes a count endpoint, not a continuous measurement or a time-to-event estimate. The primary outcome is the number of implants classified as surviving at the 3-year follow-up visit after loading. No numerical result is recorded, and the registry reports no statistical analyses. The explanations below describe general statistical considerations for this kind of study; they are not claims about methods actually used in the trial.
What a count endpoint represents
In general, a count records how many units meet a defined outcome. Here, the named unit is the implant. A count should be interpreted alongside its denominator: the number of implants assessed and the definition of survival. The registry record gives 47 implants in the stated intention-to-treat population and mentions 42 implants in connection with the 3-year follow-up, but the endpoint description is incomplete at that point. It does not provide the number meeting the survival definition or clearly state the denominator used for the final result.
Subjects and implants are not interchangeable units. The record describes 45 subjects and 47 implants, so the number of implants exceeds the number of subjects. If more than one implant belongs to a participant, outcomes from implants in the same participant may be related. In general, analysis methods can need to account for such clustering rather than treating all implants as independent observations. The registry record does not report whether any such method was used.
Uncertainty and precision
In general, an estimate is more informative when accompanied by an uncertainty measure, such as a confidence interval. A confidence interval describes the range of values compatible with the observed data under a specified statistical method. It is not a guarantee that the true value lies in that range, and its interpretation depends on the method and assumptions. The registry record gives no survival estimate and no confidence interval, so neither the observed magnitude nor its precision can be assessed.
For a count of surviving implants, the denominator and handling of participants without follow-up are central to interpretation. A result based only on implants assessed at the visit answers a different descriptive question from one that includes all enrolled implants under an explicit missing-outcome rule. The record calls its population intention-to-treat and states that it includes all participants who received at least one implant. It also reports loss to follow-up and mentions a follow-up population, but does not complete the sentence that would clarify how the endpoint was calculated. The actual analysis population and missing-data procedure are not reported in the registry record.
Single-group design and comparisons
In general, a single-group study can describe outcomes in the observed cohort, but it does not estimate a randomized contrast with a concurrent control group. Without such a comparator, changes or outcomes cannot be attributed to the implant alone by comparing groups within the study. The design recorded is single-group, and no allocation to competing groups is reported. A statistical comparison between treatment arms would therefore not correspond to the recorded design.
The registry includes a planning illustration based on a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. These are planning assumptions for a hypothetical two-arm calculation, not a description of this single-group trial’s design. The record does not report the trial’s own sample-size justification. Planning illustrations are not observed power and do not supply evidence about the trial’s outcome. The registry’s illustration also refers to fractions of an observed effect; because no primary outcome effect is reported in the record, those assumptions should not be read as trial findings.
Multiplicity and secondary outcomes
In general, assessing multiple outcomes creates multiple opportunities to observe a result that appears noteworthy by chance. Statistical approaches can address this issue, but their choice depends on which outcomes are confirmatory and how the analysis plan defines the testing strategy. The registry lists secondary measures concerning implant stability, marginal bone level alteration, probing pocket depth, bleeding on probing, plaque and gingival zenith score. It reports 7 outcome measures overall, but no statistical analyses or multiplicity procedure. The record does not identify a testing hierarchy or state whether adjustments were planned.
Model assumptions
General statistical methods rely on assumptions suited to the outcome and study design. For example, a model that treats observations as independent may be inappropriate if multiple implants from a participant are correlated. A normal approximation used in planning calculations is an assumption of that illustration; it does not establish that this approximation was used to analyze the clinical outcomes. The registry record does not report the outcome model, its assumptions, diagnostics or sensitivity analyses. No further method can be inferred from the stated endpoint alone.
Overall, the registry identifies the outcome, follow-up time and study population, but not the numerical result or analysis methods needed to evaluate the estimate. Any interpretation of effect size, statistical uncertainty or robustness would require information not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 7 outcome measures overall. The primary outcome is implant survival; the listed secondary outcomes concern implant stability, marginal bone level alteration, probing pocket depth, bleeding on probing, plaque and gingival zenith score. These outcomes address different aspects of the implant and surrounding tissues. The record does not report a statistical analysis plan, a testing hierarchy, or a method for adjusting for multiple comparisons. Because no analyses are reported, it is not possible to determine whether multiplicity was considered in the trial’s analysis.
The registry describes an intention-to-treat population consisting of all participants who received at least one implant: 45 subjects and 47 implants. It also reports that 5 subjects and 5 implants were lost to follow-up at the 3-year visit, and gives 40 subjects and 42 implants as the basis for a sentence that ends incomplete. The exact denominator for the primary endpoint and the treatment of missing outcomes are not reported in the registry record. No imputation method, missing-data model or sensitivity analysis is reported.
In general, an intention-to-treat label describes an analysis population, but it does not by itself specify how missing outcomes are handled. A complete description would make clear which participants or implants contribute to each endpoint and what assumptions are used for observations not available at follow-up. The registry’s description does not resolve those details. No statistical analyses are reported, so there is no basis for assessing the effect of missing data or multiplicity on any estimated result.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| OsseoSpeed™ TX | 0 | 45 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| OsseoSpeed™ TX | 0 of 45 |
The adverse-event summary lists 45 participants at risk in the OsseoSpeed™ TX group for serious adverse events and 0 affected. It also lists 45 at risk for other adverse events and 0 affected. These entries describe what is recorded in the registry summary; they are not a numerical measure of implant survival or a substitute for the primary endpoint.
The record does not list serious adverse-event terms, and the death count is not reported. The zero affected entries should therefore be read narrowly as the counts recorded in those adverse-event categories, not as proof that no health events of any kind occurred. The registry record does not provide further detail about how events were collected, monitored, classified or attributed.
In general, safety counts depend on the event definitions, surveillance procedures, observation period and completeness of reporting. A count of participants affected is also different from a count of events, because one participant can experience more than one event. The record does not supply enough detail to evaluate these aspects. The reported adverse-event entries should be interpreted as registry reporting, not as a comprehensive account of all possible safety outcomes.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to assess implant survival at the 3-year follow-up after loading, along with several secondary measures. It identifies 45 enrolled participants and an intention-to-treat population of 45 subjects and 47 implants. It also reports that 5 subjects and 5 implants were lost to follow-up by the 3-year visit, and mentions 40 subjects and 42 implants in an incomplete description of the follow-up basis.
What the record does not provide is the numerical primary outcome result. There is no reported count of surviving implants, survival rate, confidence interval or statistical test. As a result, the posted information cannot establish the observed frequency of survival or the precision of an estimate. The absence of a reported result is not evidence that the outcome was either favorable or unfavorable.
The study has no separate comparator group and is recorded as single-group, with no randomized allocation. Even if a numerical outcome were available, a single-group result would describe the study cohort; it would not be a randomized estimate of the difference between this implant and another intervention. The open design and lack of a recorded comparator are important when considering causal or comparative claims.
The registry’s stated hypothesis concerns early loading as a safe and predictable procedure. The record does not provide the statistical results needed to assess that hypothesis. Nor does it report numerical results for the secondary outcomes. General claims about what a statistical test or confidence interval could show do not fill that gap: the relevant estimates and methods are not reported in the registry record.
The study remains informative as a description of the intended population, device, follow-up timing and outcomes selected for assessment. However, the record’s incomplete follow-up description, absent outcome estimates and unreported analysis methods limit interpretation. It does not support a conclusion about treatment efficacy, comparative benefit, or the certainty of any clinical effect.
13. Why This Trial Matters Statistically
This study illustrates why a clearly defined endpoint is only one part of interpreting a clinical trial. The registry specifies implant survival, the assessment method and the follow-up time. It also distinguishes the implant count from the subject count: 45 subjects and 47 implants are described in the intention-to-treat population. Those details help identify what the study intended to measure, but they do not provide the measured result.
Follow-up completeness is also consequential. The record reports 5 subjects and 5 implants lost to follow-up by the 3-year visit, while giving 40 subjects and 42 implants as a basis for a statement that is incomplete. Without the final endpoint denominator and a stated rule for missing outcomes, readers cannot tell precisely how the survival result would be formed. This is a statistical reporting issue, not merely a matter of presentation.
The single-group design makes the distinction between description and comparison especially important. A cohort outcome can describe what was observed in the enrolled participants, but no concurrent randomized group is available to estimate a comparative effect. In general, statistical methods cannot create a randomized comparison that the design did not include.
Finally, the record reports no statistical analyses or numerical outcome estimates. It therefore offers no basis for examining precision, uncertainty, or the consistency of results across the listed secondary measures. The case underscores a general principle: design details, outcome definitions, denominators and analysis results are all needed to interpret evidence. The registry’s record identifies several of these elements, while leaving key numerical and methodological information unreported.
14. 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 specific to this record restrict interpretation. First, no numerical result is reported for the primary endpoint of implant survival. The record gives no survivor count, rate, confidence interval or statistical test. It also does not provide numerical results for the secondary outcomes.
Second, the follow-up description is incomplete. The registry reports 45 subjects and 47 implants in the intention-to-treat population, 5 subjects and 5 implants lost to follow-up, and 40 subjects and 42 implants as a basis for a sentence that ends before the primary endpoint denominator is clarified. The missing-data handling and the exact analysis population are not reported in the registry record.
Third, the study is single-group, open and without a recorded randomized allocation or comparator. This limits the scope of any potential inference to describing outcomes in the studied group rather than estimating a randomized comparison. The registry record does not report adjustment for other factors or an analysis plan that might otherwise clarify interpretation.
Fourth, the official title refers to the anterior maxilla, while the brief summary refers to the posterior maxilla. The record does not resolve this difference. It also does not report the statistical analysis methods, multiplicity approach, outcome-assessment procedures beyond clinical and radiographic evaluation for survival, or sample-size justification. The adverse-event listing does not report deaths or event terms. These omissions prevent a fuller assessment of outcome precision, robustness, safety reporting and the exact setting to which the study description applies.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population — NCT01389258.
- Registry record last updated 2019-10-15; status last verified 2019-10.
- Results first posted 2019-10-08.
- 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.
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18. Record Summary
The registry record describes a completed, prospective, open, multi-center, single-group study of OsseoSpeed™ TX narrow implants in a Chinese population with a partially edentulous jaw. The intervention is described as implants with a 3 mm diameter and lengths of 11–15 mm. The recorded start is 2011-06 and primary completion is 2014-08.
The primary endpoint is implant survival, assessed clinically and radiographically at the 3-year follow-up visit after loading. The record describes 45 subjects and 47 implants in its intention-to-treat population, and reports 5 subjects and 5 implants lost to follow-up. It mentions 40 subjects and 42 implants in an incomplete follow-up statement.
No numerical primary or secondary outcome results, statistical analyses, or confidence intervals are reported. The record lists 0 participants affected in the serious and other adverse-event categories, while deaths are not reported. The official title and brief summary differ in their description of the maxillary location.