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 Cyanoacrylate and Laser and Dentin Sensitivity (NCT01111474), a randomized na study. The primary outcome is Change of the Pain Sensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01111474 |
| Phase | NA |
| Condition | Dentin Hypersensitivity, Dentin Sensitivity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 62 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Federal University of São Paulo |
| Results posted | Yes |
2. Clinical Question
Population
Participants with dentin hypersensitivity or dentin sensitivity contributed teeth described as sensitive in the cervical region. The primary outcome description states that 62 participants contributed 434 teeth in a split-mouth design. Eligibility criteria and further details about the participant population are not reported in the registry record.
Intervention
Cyanoacrylate was applied to the cervical region of a sensitive tooth in three applications, with a 48-hour interval. The registry names Super Bonder® in its summary and describes cyanoacrylate as the treatment being evaluated.
Comparator
The comparison was low intensity laser treatment. The record describes three applications at 48-hour intervals, using an application of 1Joule/cm^2 for eight seconds at three points along the dental neck, with an infrared wavelength of 795nm.
Primary question
The study aimed to compare change in pain sensitivity from baseline to 180 days for teeth treated with cyanoacrylate and teeth treated with low intensity laser. The study summary frames the question as whether cyanoacrylate is equally effective as laser treatment. Numerical results for that comparison are not reported in the registry record, so the treatment contrast cannot be determined from the posted results.
3. Trial Design
The registry record describes this as a randomized trial, with triple masking and a parallel model. Its primary outcome population description also specifies a split-mouth design: 62 participants contributed 434 teeth, with teeth treated using laser or cyanoacrylate. These descriptions are both part of the record. It does not explain how the parallel model designation relates to the split-mouth description, so the allocation structure cannot be clarified further from the registry record.
The two treatments were delivered to teeth, rather than being described only as treatments assigned to separate participant groups. The laser description specifies three applications at 48-hour intervals; the cyanoacrylate description likewise specifies three applications separated by 48 hours. The record does not report how teeth were selected or assigned within each participant, or whether allocation concealment was used.
Triple masking indicates that the record classifies the trial as having three masked parties, but it does not identify which parties were masked or how masking was maintained. More detail about randomization, the people involved in treatment delivery, or outcome assessment is not reported in the registry record.
The trial is listed as completed. The sponsor is the Federal University of São Paulo. The registry record does not report a sample-size justification or further information about the recruitment setting. Its design descriptions establish that a randomized treatment comparison was intended, but the absence of primary outcome values means that the results of that comparison cannot be assessed.
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: The patients which had not achieved an initial level of hypersensitivity were excluded from the trial before assignment to the groups.
Overall Study
| Stage | All Study Participants |
|---|---|
| STARTED | 74 |
| COMPLETED | 62 |
| NOT COMPLETED | 12 |
Reasons for not completing this period:
| Reason | All Study Participants |
|---|---|
| Lost to Follow-up | 12 |
Analysis population for the primary outcome, as defined in the registry: 62 participants contributed with 434 teeth in a split mouth design: 216 teeth were treated with laser and 218 teeth were treated with cyanoacrylate.
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.
Population: 62 participants contributed with 434 teeth in a split mouth design: 216 teeth were treated with laser and 218 teeth were treated with cyanoacrylate.
| Characteristic | Unit | All Study Participants |
|---|---|---|
| Participants analysed | 62 | |
| Age, Continuous | years | 31.4 (SD 10.7) |
| Sex/Gender, Customized: Male | participants | 15 |
| Sex/Gender, Customized: Female | participants | 47 |
6. Primary Endpoint
The registry lists the primary outcome as Change of the Pain Sensitivity, measured over Baseline and 180 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in pain sensitivity, measured as a score on a numerical pain assessment scale. The scale ranges from 0, meaning no pain, to 10, meaning the worst possible pain. Higher scores represent worse pain. The timeframe is baseline and 180 days, and the registry describes change as the difference between baseline pain sensitivity and pain sensitivity after 180 days.
Using a change measure is one way to describe how an outcome differs between an initial assessment and a later assessment. In general, such a measure can convey whether pain scores have changed over time. The direction and size of a treatment contrast depend on the values and on the convention used to subtract one assessment from another. The registry record does not provide numerical change results, so it is not possible to establish the direction or magnitude of change for either treatment from the posted results.
The endpoint is a mean, with standard deviation as its stated measure of dispersion. In general, a mean describes the average score or average change, while a standard deviation describes variability among the measured values. Both can help readers understand the outcome, but neither can be interpreted for this comparison without reported values. The registry record does not provide primary outcome means, standard deviations, confidence intervals, or a treatment-effect estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record identifies the primary outcome but does not report its numerical results. It describes change in pain sensitivity between baseline and 180 days, yet no mean change, standard deviation, between-treatment contrast, or uncertainty estimate is available in the record. Consequently, the direction and size of the observed comparison cannot be described.
The record lists zero analyses. That listing does not establish why analysis results are absent, whether analyses were conducted outside the registry, or whether results were submitted elsewhere. Those details are not reported in the registry record. The record also lists two outcome measures, but it does not give the numerical primary outcome results needed to judge the treatment comparison. The secondary outcome is quality of life improvement, for which numerical results are also not reported in the registry record.
The trial’s summary states that the study aimed to evaluate two treatments and frames its hypothesis as whether cyanoacrylate is equally effective as laser treatment. A statement of the study aim is not evidence that the treatments produced similar outcomes. In general, concluding that treatments are similar requires a defined analysis and sufficiently precise estimates against a prespecified criterion for similarity or equivalence. Such a criterion and analysis are not reported in the registry record. No claim of equivalence or difference can therefore be drawn from the stated hypothesis alone.
Precision cannot be evaluated without an estimate and its uncertainty. In general, a confidence interval shows a range of values compatible with the observed data under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but the interval’s implications depend on the clinical question and the analysis plan. No confidence interval is reported for the primary comparison. The record therefore does not show whether a potential treatment contrast is estimated precisely or imprecisely.
The design description also matters when interpreting the intended comparison. The record calls the model parallel and describes a split-mouth population in which teeth received the two treatments. In general, measurements from teeth belonging to the same participant may be related, rather than independent. An analysis that accounts for this relationship may be important for valid uncertainty estimates. The statistical method used to handle the design is not reported in the registry record, so it is not possible to assess whether this relationship was addressed.
The record’s safety entries list zero serious adverse events and zero other adverse events in the treatment group listings, with 62 participants at risk for each entry. These are registry-recorded counts; they do not supply information about how events were collected, defined, or monitored. Death counts are not reported in the registry record. Safety entries should not be read as a substitute for the missing primary outcome results.
Overall, the posted information describes the question, outcome scale, timing, treatment procedures, and some design features. It does not provide the estimates needed to quantify the primary treatment comparison. The record supports describing the trial’s intended comparison, but not a conclusion about the relative pain outcomes.
9. Statistical Methods Explained
The registry describes the primary outcome as a mean of a continuous measure, with standard deviation as the dispersion statistic. General statistical explanation can help clarify what those choices mean, although no numerical outcome estimates are reported in the registry record.
What does a mean describe?
A mean is an average of measured values. For a pain score, it gives a compact description of the scores in a group or of their changes over time. It does not show the full distribution: different sets of observations can have the same mean while differing in their spread or shape. A mean is most informative when read alongside a measure of variability and a clear account of which observations were included.
The endpoint is a change score comparing baseline with the assessment after 180 days. Change scores can summarize within-person or within-tooth movement over time, depending on how the data are organized and analyzed. The registry record defines the outcome as a difference between baseline and the later assessment, but does not provide a numerical convention beyond that description. Readers should not infer whether positive or negative change represents improvement without the reported estimates and the precise calculation convention.
Why report a standard deviation?
In general, a standard deviation describes how dispersed individual measurements are around their mean. A smaller standard deviation indicates that observations are more closely clustered around the mean; a larger one indicates greater spread. It is not a measure of precision of the mean by itself. Precision also depends on the amount of information and the design, and a standard deviation cannot replace a confidence interval for a treatment contrast.
A treatment comparison commonly focuses on the difference between groups or treatment conditions, together with uncertainty around that difference. General statistical practice distinguishes the estimated effect from its precision: the estimate describes the observed contrast, while an interval or other uncertainty measure indicates how much the estimate could vary under the analysis assumptions. Neither an estimate nor an interval for this primary outcome is reported in the registry record.
Why does the split-mouth description matter?
General statistical reasoning treats related measurements differently from independent measurements. When a participant contributes teeth receiving more than one treatment, observations from that participant may share characteristics and may be correlated. Treating every tooth as fully independent can understate uncertainty if the within-participant relationship is ignored. A suitable analysis might account for pairing, clustering, or other dependence in the design; the specific method used in this trial is not reported in the registry record.
The record identifies a split-mouth design in the outcome population description while also listing a parallel model. Those terms describe different aspects of a trial design, and the record does not explain their relationship in this study. Without further detail about allocation and analysis, readers cannot determine how the reported design labels were implemented or how the dependence among teeth was handled.
What can the masking label establish?
The registry labels the study triple masked. In general, masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting, depending on who is masked and how. The label alone does not identify the masked parties or explain whether participants, clinicians, assessors, or analysts knew treatment assignments. Those details are not reported in the registry record, so the extent and practical implementation of masking cannot be evaluated.
How should the planning illustration be read?
The stated planning assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The illustration is described as planning for a stated fraction of the observed effect. It is not the trial’s own design justification, and the registry record does not report the trial’s sample-size rationale. Planning calculations are prospective illustrations of what might be required under specified assumptions; they are not observed power and do not establish what the trial was capable of detecting.
Because the registry record does not report the observed primary treatment effect, the basis for interpreting an illustration tied to that effect is not available in the record. The assumptions should not be mistaken for analysis methods used to produce trial results. Details such as the trial’s own power target, effect-size assumptions, or any sample-size adjustment are not reported in the registry record.
What is missing from the inferential report?
The registry record does not report a test statistic, p-value, confidence interval, model specification, covariate adjustment, or treatment-effect estimate for the primary outcome. These are not interchangeable items: a p-value addresses compatibility with a specified statistical hypothesis under assumptions, while an effect estimate and its interval describe the magnitude and precision of a contrast. In general, a p-value alone would not indicate whether an effect is clinically important, and a nonsignificant result would not prove that treatments are equivalent.
The record also does not describe how missing observations were handled, whether the analysis followed assignment or treatment received, or whether sensitivity analyses were conducted. These omissions limit interpretation of the methods and prevent a reader from assessing how the analysis addressed the stated design. Since numerical results and analysis details are absent, statistical conclusions about the primary comparison cannot be reconstructed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome of change in pain sensitivity and a secondary outcome of quality of life improvement. It also reports two outcome measures. Numerical results for either outcome are not reported in the registry record. The record does not describe whether other planned outcomes or analyses were considered.
In general, multiplicity arises when several outcomes, comparisons, time points, or analyses are examined. Looking at many results can increase the chance of finding an apparently notable result by chance, depending on the analysis strategy. Researchers may address this in different ways, but whether an adjustment or other multiplicity strategy was planned or used is not reported in the registry record.
The primary endpoint uses baseline and 180-day assessments. The record does not provide further time-point results or state how any other assessments were incorporated. It does not report interim analyses or an analysis plan specifying which comparison was primary for inference.
Missing-data methods are not reported in the registry record. There is no information about missing outcome measurements, exclusions, imputation, or sensitivity analyses. Likewise, the analysis populations are not described. Although the outcome description says that 62 participants contributed teeth in a split-mouth design, the record does not clarify how participants or teeth were handled in the analysis or whether all available observations were included.
These reporting gaps do not establish that a particular method was or was not used. They mean that readers cannot assess multiplicity control, the impact of missing observations, or the relationship between the described population and the analyzed population from the registry record.
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 |
|---|---|---|---|
| Cyanoacrylate | 0 | 62 | 0.0% |
| Laser | 0 | 62 | 0.0% |
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 |
|---|---|
| Cyanoacrylate | 0 of 62 |
| Laser | 0 of 62 |
The registry’s adverse-event entries list zero serious adverse events among 62 participants at risk for cyanoacrylate and zero among 62 at risk for laser. The entries also list zero other adverse events among 62 participants at risk for each treatment. These are the counts recorded in the registry and should be read as such, rather than as a detailed account of safety monitoring.
The trial’s primary outcome population description uses a split-mouth design, so the treatment listings do not necessarily represent separate participant groups. The denominators should not be added to create a combined participant count. The registry does not explain how adverse events were attributed when a participant received both treatments, or how events were defined, collected, and monitored.
Death counts are not reported in the registry record. No serious adverse-event terms are listed. The absence of a listed term does not provide information about event ascertainment or reporting beyond what the registry entries state. These safety figures also do not provide evidence about the primary pain outcome, whose numerical results are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to compare cyanoacrylate with low intensity laser treatment for cervical dentin sensitivity. It describes treatment procedures, a pain-sensitivity outcome, and an assessment at 180 days. The record also identifies a randomized, triple-masked trial and describes a split-mouth population, while listing a parallel model.
Those design and outcome descriptions do not show what happened to pain scores. The registry record does not report numerical results for the primary endpoint, including mean changes, variability, or a contrast between the treatments. It therefore cannot show which treatment had a lower average pain score or quantify any difference. It also cannot establish whether the outcomes were similar, whether a comparison was statistically precise, or whether any observed difference would be clinically important.
The study summary’s stated hypothesis asks whether cyanoacrylate is equally effective as laser treatment. In general, evidence of similarity or equivalence requires more than an absence of a reported difference: the comparison needs an appropriate design and analysis, a defined criterion, and estimates precise enough to address that criterion. The registry record does not report those details or the numerical results needed to evaluate them.
The record lists zero serious and zero other adverse events in the treatment entries, but it does not provide the context needed to assess event monitoring or attribution. Those entries should not be used to infer more than the recorded counts. Death counts are not reported in the registry record.
Accordingly, the posted information supports an account of the intended research question and some trial features, but not a conclusion about comparative effectiveness or safety. Missing results should not be interpreted as evidence that the treatments were the same, different, beneficial, or ineffective.
13. Why This Trial Matters Statistically
This trial raises a useful statistical question about how to compare outcomes when treatment is applied to teeth within the same participant. The registry’s outcome description identifies a split-mouth design, and such designs can create related observations. As a general principle, accounting for that dependence is important when estimating uncertainty. The analysis method is not reported in the registry record, so the adequacy of that handling cannot be assessed.
The record also illustrates why design labels and implementation details matter. It lists a parallel model while describing a split-mouth population. Both descriptions should be retained rather than choosing one without evidence. Clarification about allocation, masking, and the unit of analysis would help readers understand how the trial was conducted and how its results should be interpreted.
The clinical question is framed around whether a lower-cost treatment is equally effective as laser treatment. A question of equality or equivalence is statistically distinct from simply asking whether a conventional test finds a difference. General interpretation requires an explicit criterion and sufficiently precise estimates. The registry record does not report these details or the outcome estimates, so the central statistical question remains unanswered by the posted results.
Finally, an endpoint definition and a completed-trial status are not substitutes for outcome reporting. Means, variability, treatment contrasts, and uncertainty are necessary to evaluate the magnitude and precision of a comparison. Their absence limits what can be learned from this registry record, even though the intended outcome and treatment procedures are described.
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.
Numerical primary outcome results are not reported in the registry record. This prevents assessment of the direction, magnitude, and precision of the treatment comparison. The registry also lists zero analyses, but does not explain why analysis results are absent or whether results were submitted elsewhere.
The design is described using both a parallel model label and a split-mouth population description. The record does not clarify how these labels relate, how teeth were allocated within participants, or what unit was used for the primary analysis. It does not report the statistical approach used to account for related teeth from the same participant.
Important operational details are also not reported, including eligibility criteria, allocation concealment, the parties included in triple masking, and how masking was maintained. The registry does not describe the analysis population, handling of missing data, or sensitivity analyses. Whether multiplicity was addressed is also not reported.
The primary outcome is defined as change between baseline and 180 days, but numerical summaries and an explicit direction convention for the reported change are not available. The registry record does not provide a sample-size justification or details of the trial’s own statistical plan. These limitations restrict both interpretation of the intended methods and assessment of the clinical comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cyanoacrylate and Laser and Dentin Sensitivity — NCT01111474.
- Registry record last updated 2020-08-17; status last verified 2020-08.
- Results first posted 2020-08-17.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed randomized trial is listed as a comparison of cyanoacrylate and low intensity laser treatment for dentin sensitivity. The registry describes triple masking and a parallel model; its primary outcome population description specifies a split-mouth design in which 62 participants contributed 434 teeth.
The primary endpoint was change in pain sensitivity from baseline to 180 days, measured on a numerical scale from 0, no pain, to 10, worst possible pain. The record lists quality of life improvement as a secondary outcome. It does not report numerical results for either outcome or describe the statistical analysis used.
Adverse-event entries record zero serious and zero other events for each treatment listing; death counts are not reported in the registry record. The absent outcome estimates mean that the posted results do not establish the direction or precision of the primary treatment comparison.