Chronic PeriodontitisNCT01568944
Role of Infected Blood Dendritic Cells in Heart Disease Risk
A study testing Oral Antibiotic and Oral Rinse and Standard Treatment in people with Chronic Periodontitis, run by Augusta University at 1 site in United States.
Trial summary
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Oral Antibiotic and Oral Rinse and Standard Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generalized moderate to severe chronic periodontitis
Who cannot join
- diabetes
- antibiotics treatment within 3 months
- treatment with steroids, phenytoin, cyclosporin, coumadin
- presence of conditions requiring prophylactic antibiotics per AHA
- cancer, HIV, hepB, lupus, prediagnosed heart disease, renal disease
- smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
GHSU-CDM Clinical Research Center
Augusta, Georgia, 30912
About this study
Official title: Peripheral Blood Dendritic Cells and Periodontitis
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.
Read the detailed description
To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.
- Conditions
- Chronic Periodontitis
- Being tested
- Oral Antibiotic and Oral Rinse, Standard Treatment
- Keywords
- periodontal, disease, dendritic, cells, antibiotics
- Medical subject headings
- Chronic Periodontitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antibiotic and Oral RinseDrug
Also called Peridex/Flagyl/Amoxil/lansoprazole
PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard TreatmentProcedure or surgery
Also called Scaling, Root planing
Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotic and Oral Rinse | Experimental | Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg Receives: Drug: Oral Antibiotic and Oral Rinse; Procedure: Standard Treatment |
| Standard Treatment | Other | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers Receives: Procedure: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Blood Dendritic Cells From Baseline
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)
Measured: 30 days
Secondary outcomes (5)
Probing Attachment Levels
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
Measured: 30 days
Serum Cytokine Response
serum CCL20 in pg/ml by ELISA will be measured after 30 days
Measured: 30 days
Probing Depths
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
Measured: 30 days
Plaque Index
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
- thin film of visible microbial plaque in sulcus
- moderate accumulation of plaque in sulcus
- large amount of plaque in sulcus or along free gingival margin
Measured: 30 days
Gingival Index
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
- Mild inflammation, slight color change and edema, no bleeding
- Moderate inflammation, redness, edema, bleeds on probing
- Severe inflammation, marked redness and edema ulceration, spontaneous bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Christopher Cutler, Augusta University
- Investigators
- Christopher Cutler, DDS, Principal investigator, GHSU-College of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568944
- Sponsor's protocol ID
- R21DE020916
- Other IDs
- Pro00000394, R21DE020916
- Status last verified
- Apr 2020
- First submitted
- 28 Mar 2012
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zeituni AE, McCaig W, Scisci E, Thanassi DG, Cutler CW. The native 67-kilodalton minor fimbria of Porphyromonas gingivalis is a novel glycoprotein with DC-SIGN-targeting motifs. J Bacteriol. 2010 Aug;192(16):4103-10. doi: 10.1128/JB.00275-10. Epub 2010 Jun 18.
PubMed 20562309Zeituni AE, Carrion J, Cutler CW. Porphyromonas gingivalis-dendritic cell interactions: consequences for coronary artery disease. J Oral Microbiol. 2010 Dec 21;2. doi: 10.3402/jom.v2i0.5782.
PubMed 21523219
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Dendritic Cells and Periodontitis
- ClinicalTrials.gov ID
- NCT01568944
- Acronym / sponsor ID
- R21DE020916
- Conditions
- Chronic Periodontitis
- Keywords
- periodontal, disease, dendritic, cells, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.
Detailed description
To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotic and Oral Rinse | Experimental | Drug: Oral Antibiotic and Oral Rinse, Procedure: Standard TreatmentEach subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg |
| Standard Treatment | Other | Procedure: Standard TreatmentSubjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- generalized moderate to severe chronic periodontitis
Key exclusion criteria (6 listed)
- diabetes
- antibiotics treatment within 3 months
- treatment with steroids, phenytoin, cyclosporin, coumadin
- presence of conditions requiring prophylactic antibiotics per AHA
- cancer, HIV, hepB, lupus, prediagnosed heart disease, renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Antibiotic and Oral RinseAlso: Peridex/Flagyl/Amoxil/lansoprazolePO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID | Drug | Oral Antibiotic and Oral Rinse |
| Standard TreatmentAlso: Scaling, Root planingFull mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers | Procedure or surgery | Oral Antibiotic and Oral Rinse, Standard Treatment |
Primary outcome
Frequency of Blood Dendritic Cells From Baseline
Time frame: 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)
5 secondary outcomes
Probing Attachment Levels
Time frame: 30 days
Serum Cytokine Response
Time frame: 30 days
Probing Depths
Time frame: 30 days
Plaque Index
Time frame: 30 days
Gingival Index
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20562309Zeituni AE, McCaig W, Scisci E, Thanassi DG, Cutler CW. The native 67-kilodalton minor fimbria of Porphyromonas gingivalis is a novel glycoprotein with DC-SIGN-targeting motifs. J Bacteriol. 2010 Aug;192(16):4103-10. doi: 10.1128/JB.00275-10. Epub 2010 Jun 18.
- Background: PubMed 21523219Zeituni AE, Carrion J, Cutler CW. Porphyromonas gingivalis-dendritic cell interactions: consequences for coronary artery disease. J Oral Microbiol. 2010 Dec 21;2. doi: 10.3402/jom.v2i0.5782.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Cutler, DDS principal investigator
GHSU-College of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Antibiotic and Oral Rinse and Standard Treatment in people with Chronic Periodontitis, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Blood Dendritic Cells From Baseline (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01568944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.