Trial · NCT01568944
Role of Infected Blood Dendritic Cells in Heart Disease Risk
NCT01568944, Not applicable, Completed, Augusta University; results first posted 2020-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Infected Blood Dendritic Cells in Heart Disease Risk. Trials, record NCT01568944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01568944
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Infected Blood Dendritic Cells in Heart Disease Risk
- NCT number
- NCT01568944
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 18 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Chronic Periodontitis
- Interventions
- Oral Antibiotic and Oral Rinse, Standard Treatment
- First posted
- 2012-04-02
- Last updated
- 2020-05-12
- Results first posted
- 2020-05-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Blood Dendritic Cells From Baseline | 30 days | The frequency of blood dendritic cells, i.e. % CCR6+CD1a+ DCs by flow cytometry 30 days after treatment with 7 day regimen of antibiotics, mouthrinse therapy and scaling and root planing (SRP) will be compared to those who did not receive the antibiotics, but did receive mouthrinse and scaling and root planing (SRP) |
| Secondary | Probing Attachment Levels | 30 days | Probing attachment levels (distance from the cemento-enamel junction to the base of the periodontal pocket in mm at 6 sites p\[er tooth) will be monitored after 30 days |
| Secondary | Serum Cytokine Response | 30 days | serum CCL20 in pg/ml by ELISA will be measured after 30 days |
| Secondary | Probing Depths | 30 days | Probing depths (distance from the free gingival margin to the base of the pocket in mm at six sites per tooth) will be monitored after 30 days |
| Secondary | Plaque Index | 30 days | Plaque index of Silness and Loe will be monitored at buccal and lingual surfaces of all teeth after 30 days: 0 no visible microbial plaque 1. thin film of visible microbial plaque in sulcus 2. moderate accumulation of plaque in sulcus 3. large amount of plaque in sulcus or along free gingival margin |
| Secondary | Gingival Index | 30 days | Gingival index of Loe and Silness on facial, lingual and mesial surfaces of all teeth will be monitored after 30 days: 0 Normal, no inflammation 1. Mild inflammation, slight color change and edema, no bleeding 2. Moderate inflammation, redness, edema, bleeds on probing 3. Severe inflammation, marked redness and edema ulceration, spontaneous bleeding |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Blood Dendritic Cells From Baseline | 30 days | % MFI | MEAN | |
| SECONDARY | Probing Attachment Levels | 30 days | The number of teeth | mm | MEAN |
| SECONDARY | Serum Cytokine Response | 30 days | CCL20 in pg/ml of serum will be measured by ELISA | pg/ml | MEAN |
| SECONDARY | Probing Depths | 30 days | Probing depths in mm at 192 sites per patient | mm | MEAN |
| SECONDARY | Plaque Index | 30 days | plaque index at 64 sites per mouth will be measured | pI index | MEDIAN |
| SECONDARY | Gingival Index | 30 days | gingival index at 3 sites per tooth | GI | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Blood Dendritic Cells From Baseline | Oral Antibiotic and Oral Rinse | 12 | Standard Deviation 4 | % MFI | |
| Frequency of Blood Dendritic Cells From Baseline | Standard Treatment | 14 | Standard Deviation 2 | % MFI | |
| Probing Attachment Levels | Oral Antibiotic and Oral Rinse | 4.2 | Standard Deviation 6 | mm | |
| Probing Attachment Levels | Standard Treatment | 4.6 | Standard Deviation 4 | mm | |
| Serum Cytokine Response | Oral Antibiotic and Oral Rinse | 22 | Standard Deviation 5 | pg/ml | |
| Serum Cytokine Response | Standard Treatment | 32 | Standard Deviation 5 | pg/ml | |
| Probing Depths | Oral Antibiotic and Oral Rinse | 4.2 | Standard Deviation 3 | mm | |
| Probing Depths | Standard Treatment | 4.7 | Standard Deviation 4 | mm | |
| Plaque Index | Oral Antibiotic and Oral Rinse | 2 | 90% Confidence Interval 0 to 3 | pI index | |
| Plaque Index | Standard Treatment | 3 | 90% Confidence Interval 1 to 3 | pI index |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Antibiotic and Oral Rinse | 8 | |
| Overall Study | STARTED | Standard Treatment | 10 | |
| Overall Study | COMPLETED | Oral Antibiotic and Oral Rinse | 8 | |
| Overall Study | COMPLETED | Standard Treatment | 10 | |
| Overall Study | NOT COMPLETED | Oral Antibiotic and Oral Rinse | 0 | |
| Overall Study | NOT COMPLETED | Standard Treatment | 0 |
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 | Oral Antibiotic and Oral Rinse | 0 | 8 |
| Total, all-cause mortality | Standard Treatment | 0 | 8 |
| Total, other adverse events | Oral Antibiotic and Oral Rinse | 0 | 8 |
| Total, other adverse events | Standard Treatment | 0 | 8 |
| Total, serious adverse events | Oral Antibiotic and Oral Rinse | 0 | 8 |
| Total, serious adverse events | Standard Treatment | 0 | 8 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DE020916 | Peripheral blood dendritic cells and periodontitis | CUTLER, CHRISTOPHER WILLIAM | AUGUSTA UNIVERSITY | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2011 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Antibiotic and Oral Rinse vs Standard Treatment: deaths from any cause | Trial comparisons |
| Oral Antibiotic and Oral Rinse vs Standard Treatment: serious adverse events | 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/NCT01568944
GET https://conductscience.org/api/trials/v1/NCT01568944/registered