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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00000394 | Other Identifier | GHSU-HAC | |
| R21DE020916 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard Treatment | Other | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Antibiotic and Oral Rinse | Drug | PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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](streamdown:incomplete-link) | 30 days |
| Serum Cytokine Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cutler, DDS | GHSU-College of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHSU-CDM Clinical Research Center | Augusta | Georgia | 30912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20562309 | Background | 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. | |
| 21523219 | Background | Zeituni 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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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Antibiotic and Oral Rinse | 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 Oral Antibiotic and Oral Rinse: 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 Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
| FG001 | Standard Treatment | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Antibiotic and Oral Rinse | 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 Oral Antibiotic and Oral Rinse: 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 Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | % MFI | 30 days |
|
30 days
The antibiotic protocol is reported to induce gastric upset, diarrhea and/or vaginal candidiasis in some subjects. All subjects were asked if they had any of these symptoms and none were reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Antibiotic and Oral Rinse | 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 Oral Antibiotic and Oral Rinse: 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 Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| chairman | Dental College of Georgia | 706-7212442 | chcutler@augusta.edu |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D009067 | Mouthwashes |
| C010882 | chlorhexidine gluconate |
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Standard Treatment | Procedure | Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
|
|
serum CCL20 in pg/ml by ELISA will be measured after 30 days
| 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 | 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
| 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
| 30 days |
| BG001 | Standard Treatment | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Treatment | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers |
|
|
| Secondary | 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](streamdown:incomplete-link) | The number of teeth | Posted | Mean | Standard Deviation | mm | 30 days | tooth sites | tooth sites |
|
|
|
| Secondary | Serum Cytokine Response | serum CCL20 in pg/ml by ELISA will be measured after 30 days | CCL20 in pg/ml of serum will be measured by ELISA | Posted | Mean | Standard Deviation | pg/ml | 30 days |
|
|
|
| Secondary | 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 | Probing depths in mm at 192 sites per patient | Posted | Mean | Standard Deviation | mm | 30 days | sites per mouth | sites per mouth |
|
|
|
| Secondary | 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
| plaque index at 64 sites per mouth will be measured | Posted | Median | 90% Confidence Interval | pI index | 30 days | sites per mouth | sites per mouth |
|
|
|
| Secondary | 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
| gingival index at 3 sites per tooth | Posted | Median | 90% Confidence Interval | GI | 30 days | 3 sites per tooth | 3 sites per tooth |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Standard Treatment | Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers | 0 | 8 | 0 | 8 | 0 | 8 |
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| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001697 |
| Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |