Trial · NCT01929135
Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.
NCT01929135, Phase 2, Completed, Universidad de los Andes, Chile; results first posted 2014-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status. Trials, record NCT01929135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01929135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.
- NCT number
- NCT01929135
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Universidad de los Andes, Chile
- Conditions
- Chronic Periodontitis
- Interventions
- Medicated 2% atorvastatin dentifrice, Non-medicated dentifrice
- First posted
- 2013-08-27
- Last updated
- 2014-07-28
- Results first posted
- 2014-07-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Periodontal Inflammation Surface Area (PISA) | baseline and 1 month later of intervention | PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing. Change in PISA: baseline measure minus 1 month later measure. |
| Secondary | Change in Mean Pocket Depth (PD) | baseline and 1 month later | The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal). Change in mean PD: baseline measure minus 1 month later measure. |
| Secondary | Change in Clinical Attachment Level (CAL) | baseline and 1 month after intervention | The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual). Change in CAL: baseline measure minus 1 month later measure. |
| Secondary | Change in Bleeding on Probing Index (BOP) | baseline and 1 month after intervention | The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined. Change in BOP: baseline measure minus 1 month later measure. |
| Secondary | Change in Gingival Index | baseline and 1 month after intervention | Determined as score assigned to each site evaluated respect to clinical criteria as followed: Score Criteria: 0\. No inflammation 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding. Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated. The change was calculated as baseline measure minus 1 month later measure. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Periodontal Inflammation Surface Area (PISA) | baseline and 1 month later of intervention | square millimeters | MEAN | |
| SECONDARY | Change in Mean Pocket Depth (PD) | baseline and 1 month later | millimeters | MEAN | |
| SECONDARY | Change in Clinical Attachment Level (CAL) | baseline and 1 month after intervention | millimeters | MEAN | |
| SECONDARY | Change in Bleeding on Probing Index (BOP) | baseline and 1 month after intervention | percentage of BOP | MEAN | |
| SECONDARY | Change in Gingival Index | baseline and 1 month after intervention | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Periodontal Inflammation Surface Area (PISA) | Atorvastatin Toothpaste | 638.16 | Standard Deviation 398.74 | square millimeters | |
| Change in Periodontal Inflammation Surface Area (PISA) | Non Medicated Gel Toothpaste | 288.72 | Standard Deviation 168.20 | square millimeters | |
| Change in Mean Pocket Depth (PD) | Atorvastatin Toothpaste | 1.29 | Standard Deviation 0.45 | millimeters | |
| Change in Mean Pocket Depth (PD) | Non Medicated Gel Toothpaste | 0.70 | Standard Deviation 0.53 | millimeters | |
| Change in Clinical Attachment Level (CAL) | Atorvastatin Toothpaste | 0.89 | Standard Deviation 0.33 | millimeters | |
| Change in Clinical Attachment Level (CAL) | Non Medicated Gel Toothpaste | 0.49 | Standard Deviation 0.31 | millimeters | |
| Change in Bleeding on Probing Index (BOP) | Atorvastatin Toothpaste | 64.42 | Standard Deviation 18.08 | percentage of BOP | |
| Change in Bleeding on Probing Index (BOP) | Non Medicated Gel Toothpaste | 28.56 | Standard Deviation 15.56 | percentage of BOP | |
| Change in Gingival Index | Atorvastatin Group | 1.04 | Standard Deviation 0.54 | score on a scale | |
| Change in Gingival Index | Placebo Group | 0.54 | Standard Deviation 0.42 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin Group | 19 | |
| Overall Study | STARTED | Placebo Group | 19 | |
| Overall Study | COMPLETED | Atorvastatin Group | 18 | |
| Overall Study | COMPLETED | Placebo Group | 18 | |
| Overall Study | NOT COMPLETED | Atorvastatin Group | 1 | |
| Overall Study | NOT COMPLETED | Placebo Group | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Atorvastatin Group | 0 | 19 |
| Total, other adverse events | Placebo Group | 0 | 19 |
| Total, serious adverse events | Atorvastatin Group | 0 | 19 |
| Total, serious adverse events | Placebo Group | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atorvastatin Group vs Placebo Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01929135
GET https://conductscience.org/api/trials/v1/NCT01929135/registered