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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryFrequency of Blood Dendritic Cells From Baseline30 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)
SecondaryProbing Attachment Levels30 daysProbing 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
SecondarySerum Cytokine Response30 daysserum CCL20 in pg/ml by ELISA will be measured after 30 days
SecondaryProbing Depths30 daysProbing 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
SecondaryPlaque Index30 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
SecondaryGingival Index30 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

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYFrequency of Blood Dendritic Cells From Baseline30 days% MFIMEAN
SECONDARYProbing Attachment Levels30 daysThe number of teethmmMEAN
SECONDARYSerum Cytokine Response30 daysCCL20 in pg/ml of serum will be measured by ELISApg/mlMEAN
SECONDARYProbing Depths30 daysProbing depths in mm at 192 sites per patientmmMEAN
SECONDARYPlaque Index30 daysplaque index at 64 sites per mouth will be measuredpI indexMEDIAN
SECONDARYGingival Index30 daysgingival index at 3 sites per toothGIMEDIAN

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Frequency of Blood Dendritic Cells From BaselineOral Antibiotic and Oral Rinse12Standard Deviation 4% MFI
Frequency of Blood Dendritic Cells From BaselineStandard Treatment14Standard Deviation 2% MFI
Probing Attachment LevelsOral Antibiotic and Oral Rinse4.2Standard Deviation 6mm
Probing Attachment LevelsStandard Treatment4.6Standard Deviation 4mm
Serum Cytokine ResponseOral Antibiotic and Oral Rinse22Standard Deviation 5pg/ml
Serum Cytokine ResponseStandard Treatment32Standard Deviation 5pg/ml
Probing DepthsOral Antibiotic and Oral Rinse4.2Standard Deviation 3mm
Probing DepthsStandard Treatment4.7Standard Deviation 4mm
Plaque IndexOral Antibiotic and Oral Rinse290% Confidence Interval 0 to 3pI index
Plaque IndexStandard Treatment390% Confidence Interval 1 to 3pI index

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOral Antibiotic and Oral Rinse8
Overall StudySTARTEDStandard Treatment10
Overall StudyCOMPLETEDOral Antibiotic and Oral Rinse8
Overall StudyCOMPLETEDStandard Treatment10
Overall StudyNOT COMPLETEDOral Antibiotic and Oral Rinse0
Overall StudyNOT COMPLETEDStandard Treatment0

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.

TotalGroupAffectedAt risk
Total, all-cause mortalityOral Antibiotic and Oral Rinse08
Total, all-cause mortalityStandard Treatment08
Total, other adverse eventsOral Antibiotic and Oral Rinse08
Total, other adverse eventsStandard Treatment08
Total, serious adverse eventsOral Antibiotic and Oral Rinse08
Total, serious adverse eventsStandard Treatment08

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
20562309BACKGROUNDPubMed
21523219BACKGROUNDPubMed

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R21DE020916Peripheral blood dendritic cells and periodontitisCUTLER, CHRISTOPHER WILLIAMAUGUSTA UNIVERSITYNATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH2011 to 2012

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Oral Antibiotic and Oral Rinse vs Standard Treatment: deaths from any causeTrial comparisons
Oral Antibiotic and Oral Rinse vs Standard Treatment: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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