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 Flowable Resin Versus Self-Adhesive Dressing for Palatal Donor-Site Protection (NCT06593275), a randomized na study. The primary outcome is Postoperative Pain Intensity at the Palatal Donor Site.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06593275 |
| Phase | NA |
| Condition | Perception of Pain, Protection of the Palate |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Universidad de Especialidades Espiritu Santo |
| Results posted | Yes |
2. Clinical Question
Population
Adult participants undergoing free gingival graft harvesting, with a palatal donor-site wound. The registry record reports enrollment of 12 participants. It does not report further participant characteristics in the information available for this comparison, such as age distribution, sex, baseline pain, or clinical features of the donor sites.
Intervention
A hemostatic collagen sponge covered by a flowable resin composite barrier. The brief description says the barrier was bonded to the palatal enamel surfaces of adjacent teeth using an adhesive protocol and light-cured. This approach was intended to protect the donor site after the graft was harvested.
Comparator
A hemostatic collagen sponge covered by a self-adhesive oral dressing, trimmed and adapted over the wound and stabilized with sutures. The trial compared the two protective approaches in a randomized, parallel-group design. The record does not describe masking.
Primary question
How did self-reported palatal donor-site pain, recorded daily on a 0-to-10 numerical rating scale from postoperative day 1 through postoperative day 14, compare between the two protective approaches? The registry record describes the measurement plan but does not report the numerical pain results or an inferential comparison, so the direction and precision of any difference cannot be assessed.
3. Trial Design
This was a pilot randomized clinical trial comparing two ways to cover a palatal donor-site wound after free gingival graft harvesting. The registry record lists a parallel design and random allocation. Enrollment was 12. It describes one group receiving a hemostatic collagen sponge covered with flowable resin composite and another receiving the sponge covered with a self-adhesive oral dressing stabilized with sutures. The record lists no masking.
The primary outcome was postoperative pain intensity at the palatal donor site. Participants were asked to record pain once daily from postoperative day 1 through postoperative day 14 on an 11-point numerical rating scale, with 0 representing minimum pain and 10 maximum pain. Responses were collected electronically through Google Forms. The record describes daily scores for each treatment arm, but it does not report the arm-level numerical scores, their dispersion, or a statistical comparison.
Secondary outcomes listed in the record were free gingival graft-harvesting time, protective-material application time, and intraoral retention time of the protective material. Their numerical results are not reported in the registry record. The record lists four outcome measures and zero analyses. It does not report the planned statistical methods, allocation concealment procedures, eligibility criteria beyond the adult participants described in the study summary, or how the random sequence was generated.
The study status is terminated. The recorded start date is 2023-10-30 and the primary completion date is 2025-02-15. The registry record does not explain why the study was terminated or whether termination was related to enrollment, conduct, or results. It also does not report a protocol-based sample-size justification. The registry entries available therefore establish the comparison and intended measurements, but not a completed numerical assessment of the primary question.
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: All 12 enrolled participants met the eligibility criteria, provided written informed consent, and underwent random allocation. No participants were excluded after enrollment or before assignment to the study arms.
Overall Study
| Stage | Flowable Resin Composite | Self-Adhesive Oral Dressing |
|---|---|---|
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 0 |
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 | Flowable Resin Composite | Self-Adhesive Oral Dressing | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 6 | 12 | |
| Age, Continuous | years | 39 (SD 14) | 53.17 (SD 8.70) | 46.08 (SD 13.35) |
| Sex: Female, Male: Female | Participants | 4 | 4 | 8 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 4 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Graft Length (mm) | millimeters | 18.83 (SD 7.026) | 19.17 (SD 5.879) | 19 (SD 6.179) |
| Graft Width (mm) | millimeters | 6 (SD 1.2649) | 5.5 (SD 0.5477) | 5.75 (SD 0.965) |
| Graft Thickness (mm) | millimeters | 2 (SD 0.316) | 1.92 (SD 0.204) | 1.96 (SD 0.257) |
6. Primary Endpoint
The registry lists the primary outcome as Postoperative Pain Intensity at the Palatal Donor Site, measured over Daily from postoperative day 1 through postoperative day 14.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | NRS points (0-10) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was postoperative pain intensity at the palatal donor site. Participants self-reported pain once daily using an 11-point numerical rating scale ranging from 0, minimum pain, to 10, maximum pain. The planned measurement period extended from postoperative day 1 through postoperative day 14. The registry record says responses were collected electronically through Google Forms and recorded for each treatment arm.
Pain intensity is a continuous patient-reported measure: a participant selects a point on a scale to describe the experience. Such a measure can capture differences in symptom severity that may not be represented by a simple event count. Daily recording can also describe how pain varies over the recovery period rather than restricting assessment to a single time. These are general features of repeated patient-reported measurements, not evidence that either protective approach produced a particular pattern in this trial.
The registry record identifies the planned summary as a mean with standard deviation, but does not report the resulting daily scores or arm-level summaries. It also does not state how daily values were to be combined into one primary comparison, or how missing daily responses were to be handled. Because the outcome was measured across multiple postoperative days, the absence of reported numerical results prevents assessment of the size, direction, and precision of any contrast between the randomized groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of flowable resin composite and a self-adhesive oral dressing for palatal donor-site protection. It reports enrollment and the intended daily pain measurements, but it does not report numerical primary-outcome results. There are no arm-level means, standard deviations, confidence intervals, or inferential statistics for the daily pain scores in the record. Consequently, the posted information does not establish whether pain scores differed between the groups, how large any difference might have been, or how precisely it was estimated.
This limitation matters because the outcome was measured repeatedly across postoperative days. A set of daily values could be interpreted day by day, summarized across a period, or analyzed with a model that accounts for measurements within the same participant. The registry record does not report which summary or analysis was intended, and no numerical series is available to inspect. The fact that daily scores were planned does not itself show that all participants completed every assessment or that the observed pattern favored either approach.
The trial is identified as a pilot and lists enrollment of 12. That is a description of the study’s scale, not a result about the comparative effects. With no reported outcome estimates, statistical significance and uncertainty cannot be evaluated from the registry record. No post hoc recalculation is possible from the reported primary-outcome information. There is also no basis to infer that an unreported comparison was null, favorable, or unfavorable.
The status is terminated, but the record does not state the reason. Termination alone does not indicate why the study ended, whether all planned assessments were completed, or whether the decision was connected to any observed outcome. The record likewise does not report a protocol-based sample-size justification or a statistical analysis plan. Those omissions limit appraisal of how the study was designed to distinguish a meaningful group difference from random variation.
The registry record describes secondary outcomes involving graft-harvesting time, time to apply the protective material, and material retention time, but gives no numerical results for them. It also records zero analyses. That registry entry should not be interpreted as proof that no analysis was conducted; it indicates that analyses are not listed in the record. In the absence of posted numerical findings, the appropriate interpretation is limited to the design and measurements described. No conclusion about comparative performance, pain, or material retention can be drawn from the registry information alone.
A separate planning illustration may use an observed effect as a hypothetical target, but sample-size values from such an exercise are not evidence of observed power and do not replace trial results. The illustration’s assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. Since the primary outcome estimates are not reported, no numerical planning interpretation can be verified from the registry record. Any such illustration should be understood as a hypothetical planning aid, not as an observed clinical finding.
9. Statistical Methods Explained
The registry record identifies a randomized, parallel-group pilot trial. Randomization is intended to assign participants to comparison groups by chance, which can reduce systematic differences between groups at the point of assignment. This general rationale does not establish that randomization was implemented without difficulty or that the groups were balanced on every characteristic. The record does not report how the sequence was generated, whether assignment was concealed, or whether baseline characteristics were compared.
What does a parallel-group design mean?
In a parallel-group design, participants are assigned to one treatment approach and outcomes are compared across groups. In this trial, the approaches were a collagen sponge covered with flowable resin composite and a collagen sponge covered with a self-adhesive oral dressing stabilized with sutures. The record lists no masking. It does not explain whether masking was considered feasible or whether outcome assessment involved any masked procedures. Since the primary endpoint was self-reported, the absence of masking is relevant context for interpreting measurement, but it does not by itself determine whether reports were biased.
How should a continuous outcome be understood?
The primary endpoint was pain intensity measured on a numerical rating scale from 0 to 10. The record specifies a mean and standard deviation as the outcome’s summary form. In general, a mean describes the average of observed values, while a standard deviation describes how spread out those values are around the average. Together they can summarize the level and variability of a continuous measure. They do not, by themselves, show how precise an estimated group difference is; a confidence interval is used to describe the range of values reasonably compatible with the data under the analysis assumptions.
No daily means, standard deviations, group differences, confidence intervals, or test results for pain are reported in the registry record. It is therefore not possible to explain a numerical estimate or its uncertainty for this trial. A stated outcome-summary format is not equivalent to a reported result.
Why do repeated daily measurements require care?
Pain was scheduled to be recorded daily from postoperative day 1 through postoperative day 14. Measurements from the same participant are generally related: a person’s score on one day may be associated with that person’s score on another day. This is a general feature of repeated-measures data. An analysis that treats every daily score as if it came from a different, unrelated participant may understate uncertainty. Methods for repeated measurements can account for within-participant correlation, but the registry record does not report whether such a method was planned or used.
Another issue is how to define the primary contrast when the outcome is observed at several time points. An analysis could focus on separate days, an average over days, or a trajectory across the recovery period. These approaches address different questions and can produce different summaries. The registry record notes that the primary outcome has several time points and is not reduced to one comparison. It does not report a single summary contrast or a model for the daily pattern. Without that information, readers cannot determine which statistical question an analysis would answer.
What do confidence intervals and significance tests contribute?
In general, a confidence interval conveys uncertainty around an estimated effect. A narrower interval indicates greater precision under the model and assumptions used; a wider interval indicates less precision. A significance test assesses compatibility between the data and a specified null hypothesis under its assumptions. Neither a p-value nor a confidence interval, if reported, should be interpreted without considering the study design, measurement process, and analysis choices. Here, the registry record reports no numerical estimate, confidence interval, or p-value for the primary outcome, so these concepts cannot be applied to a trial-specific result.
What is over-dispersion, and is it relevant?
Over-dispersion is a general concern for count outcomes when the observed variability exceeds what a simple count model assumes. It can affect standard errors and confidence intervals if the model does not accommodate that extra variability. The primary endpoint in this trial is a continuous pain score, not a count, so over-dispersion is not the central issue for interpreting that endpoint. The record does not provide results for the secondary outcomes or enough detail to assess the models used for them.
How should the planning illustration be read?
The registry record describes a planning illustration based on a stated fraction of an observed effect. It specifies a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It also distinguishes illustrations that report participants per arm from time-to-event illustrations that report total events; the outcomes listed for this trial are not described as time-to-event outcomes. General sample-size calculations depend on their assumptions about the effect to detect, variability, significance level, allocation, and analysis. An illustration is not an observed trial result and is not observed power. The record does not report a protocol-based sample-size justification, and no primary-outcome estimate is available to assess the illustration against trial findings.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome was measured on multiple postoperative days, and the registry record notes that it is not reduced to one comparison. When several time points or outcomes are examined, multiplicity is a general statistical concern: the more comparisons considered, the greater the chance of finding an apparently unusual result by chance if no adjustment or analysis strategy is specified. This does not mean that any particular finding in this trial is false. It means readers need to know which comparison was primary and how multiple comparisons were handled. The registry record does not report a multiplicity plan.
Missing-data handling is also not reported in the registry record. Daily electronic self-reports may be incomplete, but the record does not state whether any daily observations were missing, how missing values were treated, or whether participants with incomplete diaries were included in a particular analysis. No imputation method, sensitivity analysis, or completeness summary is reported. These details matter because missingness can affect the interpretation of repeated measurements, especially if the likelihood of reporting pain is related to the pain experienced.
The registry record does not report analysis populations, such as whether participants were analyzed according to randomized assignment or according to treatment received. It does not describe exclusions after randomization, protocol deviations, or the handling of participants who did not complete follow-up. The registry lists zero analyses, but that entry does not establish whether analyses were conducted outside the record. A statistical analysis plan is not reported in the registry record, so the timing and specification of the intended analysis cannot be assessed.
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 |
|---|---|---|---|
| Flowable Resin Composite | 0 | 6 | 0.0% |
| Self-Adhesive Oral Dressing | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Flowable Resin Composite | 0 of 6 |
| Self-Adhesive Oral Dressing | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Flowable Resin Composite | 0 of 6 |
| Self-Adhesive Oral Dressing | 0 of 6 |
The registry record reports serious adverse events, other adverse events, and deaths separately for the two treatment groups. For the flowable resin composite group, 6 participants were listed as at risk for serious and other adverse events; the record reports 0 serious adverse events, 0 other adverse events, and 0 deaths. For the self-adhesive oral dressing group, 6 participants were listed as at risk for serious and other adverse events; the record likewise reports 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious-event terms are listed.
These figures describe what was recorded in the registry, not proof that an event was impossible or that every potential harm was assessed with equal sensitivity. A zero count in a small pilot trial offers limited information about uncommon events. The registry record does not provide further detail about event definitions, surveillance procedures, follow-up completeness, or the period used for safety assessment. It also does not report non-serious events by type beyond the overall count. The figures should therefore be read as the reported event counts, with the study’s scale and the missing safety details in mind, rather than as a definitive assessment of safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized pilot trial compared two palatal donor-site protection approaches after free gingival graft harvesting. It specifies a primary outcome of daily self-reported pain intensity on a 0-to-10 scale from postoperative day 1 through postoperative day 14. It also lists secondary outcomes related to graft-harvesting time, protective-material application time, and retention time. These details describe the questions the study was intended to address.
The record does not report numerical results for the pain outcome or the secondary outcomes. It therefore does not show which approach had higher or lower pain scores, whether differences changed over time, or how variable the scores were. It does not provide an estimate of a treatment contrast or a confidence interval that could describe its precision. In the absence of those results, the registry information cannot establish that one approach performed better, worse, or similarly on the measured outcomes.
Nor does the absence of a reported comparison demonstrate that the approaches were equivalent. Evidence of similarity generally requires an appropriately designed analysis with a prespecified margin and sufficiently precise results; these details are not reported in the registry record. Likewise, the trial’s randomized design does not compensate for absent outcome estimates. Randomization is a design feature, while conclusions about observed outcomes depend on the data and analysis being reported.
The status of terminated does not explain why the study ended, and it does not establish that the planned measurements were or were not completed. The record does not report the reason for termination. It also does not report a statistical analysis plan, missing-data methods, or analysis populations. These omissions prevent a fuller evaluation of the intended comparison and the reliability of any unreported analysis.
The safety entry records zero serious adverse events, zero other adverse events, and zero deaths in each group. Those are the event counts listed in the registry and should be interpreted within the scale of this pilot study and the limited safety detail reported. Overall, the registry record supports a description of the trial design and intended measurements, but not a conclusion about comparative effects or clinical performance.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it illustrates the distinction between a clearly described research question and an interpretable result. The registry record identifies two approaches, random allocation, a parallel design, and a repeated patient-reported pain measure. Those details help define the intended comparison. But without numerical outcome results, readers cannot estimate the size or precision of any difference. A study’s design and measurement plan are important, but they do not substitute for transparent reporting of findings.
The daily pain assessments also raise a general design and analysis issue. Repeated scores from one participant are related observations, not independent measurements. A statistical plan should clarify whether the scientific target is a comparison at particular days, an average across days, or a difference in the overall trajectory. The registry record does not report this choice. Stating the target in advance helps readers distinguish a planned primary question from exploratory comparisons across multiple days.
The pilot designation makes clarity about the study’s purpose especially useful. A pilot may be intended to assess feasibility or inform future study planning, but the registry record does not state the specific objectives beyond the listed outcomes. The record does not report a protocol-based sample-size justification or results that would support a precision assessment. Any planning illustration based on an observed effect should be treated as hypothetical planning, not as evidence of observed power.
Finally, the termination status and absence of listed analyses emphasize the value of complete registry reporting. The record does not explain the termination or provide numerical outcome findings. This leaves readers able to understand the comparison that was planned, but unable to judge the trial’s outcome evidence. That distinction is important for clinical researchers who assess both study design and the completeness of public reporting.
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.
The principal limitation for interpreting this trial is that the registry record does not report numerical results for the primary pain outcome. Daily scores, arm-level means, standard deviations, and a comparison estimate are absent. The record also does not report numerical findings for the listed secondary outcomes. As a result, the direction, size, and precision of any comparative effect cannot be assessed from the registry information.
The primary outcome was scheduled at multiple time points, but the record does not state how those observations were to be summarized or modeled. It does not report whether a single primary contrast was selected, how within-participant correlation was handled, or how multiplicity across days and outcomes was addressed. Missing-data methods and the completeness of daily reporting are also not reported in the registry record.
Further design details are unavailable. The record does not describe sequence generation, allocation concealment, baseline characteristics, or analysis populations. It lists no masking but does not explain whether any outcome-assessment procedures were masked. The reason for termination is not reported in the registry record, and the record does not establish whether all planned measurements were completed.
The study enrolled 12 participants, and the safety counts are therefore limited in the amount of information they can convey about uncommon events. The registry reports zero serious adverse events, zero other adverse events, and zero deaths in each group, but does not provide event definitions, detailed surveillance methods, or the safety follow-up period. These limitations constrain conclusions about both comparative outcomes and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Flowable Resin Versus Self-Adhesive Dressing for Palatal Donor-Site Protection — NCT06593275.
- Registry record last updated 2026-10-23; status last verified 2026-07.
- Results first posted 2026-10-23.
- 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 randomized, parallel-group pilot trial comparing flowable resin composite with a self-adhesive oral dressing for palatal donor-site protection after free gingival graft harvesting. Enrollment was 12, masking was listed as none, and the study status is terminated.
The primary outcome was daily self-reported palatal donor-site pain on a 0-to-10 numerical rating scale from postoperative day 1 through postoperative day 14. Secondary outcomes concerned graft-harvesting time, protective-material application time, and material retention time. The registry record does not report numerical results for these outcomes, the reason for termination, a statistical analysis plan, or missing-data methods. It lists zero analyses. Safety entries report zero serious adverse events, zero other adverse events, and zero deaths in each group.