Chronic Periodontitis
Conditions
Keywords
periodontal, disease, dendritic, cells, antibiotics
Brief summary
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.
Interventions
DRUGOral 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
PROCEDUREStandard Treatment
Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* generalized moderate to severe chronic periodontitis
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Serum Cytokine Response | 30 days | serum CCL20 in pg/ml by ELISA will be measured after 30 days |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | Oral Antibiotic and Oral Rinse | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 4 | 48 years STANDARD_DEVIATION 5 | 46 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 8 participants | 10 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
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)
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Antibiotic and Oral Rinse | Frequency of Blood Dendritic Cells From Baseline | 12 % MFI | Standard Deviation 4 |
| Standard Treatment | Frequency of Blood Dendritic Cells From Baseline | 14 % MFI | Standard Deviation 2 |
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 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
Time frame: 30 days
Population: gingival index at 3 sites per tooth
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Antibiotic and Oral Rinse | Gingival Index | 2 GI |
| Standard Treatment | Gingival Index | 3 GI |
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 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
Time frame: 30 days
Population: plaque index at 64 sites per mouth will be measured
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Antibiotic and Oral Rinse | Plaque Index | 2 pI index |
| Standard Treatment | Plaque Index | 3 pI index |
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
Time frame: 30 days
Population: The number of teeth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Antibiotic and Oral Rinse | Probing Attachment Levels | 4.2 mm | Standard Deviation 6 |
| Standard Treatment | Probing Attachment Levels | 4.6 mm | Standard Deviation 4 |
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
Time frame: 30 days
Population: Probing depths in mm at 192 sites per patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Antibiotic and Oral Rinse | Probing Depths | 4.2 mm | Standard Deviation 3 |
| Standard Treatment | Probing Depths | 4.7 mm | Standard Deviation 4 |
Secondary
Serum Cytokine Response
serum CCL20 in pg/ml by ELISA will be measured after 30 days
Time frame: 30 days
Population: CCL20 in pg/ml of serum will be measured by ELISA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Antibiotic and Oral Rinse | Serum Cytokine Response | 22 pg/ml | Standard Deviation 5 |
| Standard Treatment | Serum Cytokine Response | 32 pg/ml | Standard Deviation 5 |