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The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease
Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.
Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.
The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-Stage Full-Mouth Disinfection | Experimental | Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved) |
|
| Periodontal care | Active Comparator | Basic oral hygiene instructions Supragingival plaque removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Stage Full-Mouth Disinfection | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Flow-mediated Dilation | All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%). | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| High-sensitivity C-Reactive Protein | The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens). | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
| Total Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo Contreras, DDS, MS, PhD | Universidad del Valle | Principal Investigator |
| Jorge H Ramirez, MD, MS | Universidad del Valle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red de Salud de Ladera E.S.E. Servicio de Odontología | Cali | Valle del Cauca Department | Colombia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24495202 | Result | Ramirez JH, Parra B, Gutierrez S, Arce RM, Jaramillo A, Ariza Y, Contreras A. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study. Aust Dent J. 2014 Mar;59(1):29-36. doi: 10.1111/adj.12139. Epub 2014 Feb 4. | |
| 21324167 | Derived | Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46. |
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Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2).
rom April 2008 to March 2011 three hundred and six subjects were assessed for eligibility to participate in this randomized clinical trial. One hundred and two patients were randomized to the control (n=55) and treatment group (n=47). At 12 weeks of follow-up, 47 patients (control group) and 41 patients (treatment group) completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Periodontal Intervention (Experimental) | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
|
| FG001 | Periodontal Prophylaxis (Active Comparator) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Periodontal Intervention (Experimental) | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Brachial Artery Flow-mediated Dilation | All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%). | The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables. | Posted | Mean | Standard Deviation | Percentage of dilatation of brachial art | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
|
One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
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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 | Periodontal Intervention (Experimental) | One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motor vehicle traffic accident | Social circumstances | Non-systematic Assessment | Death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling | Surgical and medical procedures | Non-systematic Assessment | Visual examination of periodontal tissues 24 h after periodontal therapy. |
1. Patient recruitment take more time that previously expected, 2. Longer time than expected for the standardization for laboratory techniques, 3. Changes of the study personnel during patient recruitment and laboratory analysis of biological samples
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Hernán Ramírez and Adolfo Contreras (adolfo@yahoo.com). | Universidad del Valle | 5723753778 | jorge.h.ramirez00@gmail.com |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Periodontal care | Procedure |
|
|
| Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
| White Blood Cell Count | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
| Subgingival Microbiota | Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf). | 12 weeks post-periodontal therapy |
| LDL Cholesterol | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
| Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) | Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®). Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis. | 12 weeks post periodontal therapy |
| Intercellular Adhesion Molecule 1 (ICAM-1) | 12 weeks post periodontal therapy |
| Vascular Cell Adhesion Molecule 1 (VCAM-1) | 12 weeks post periodontal therapy |
| Myeloperoxidase (MPO) | 12 weeks post periodontal therapy |
| Matrix Metalloproteinase-9 (MMP-9) | 12 weeks post periodontal therapy |
| Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) | 12 weeks post periodontal therapy |
| Universidad del Valle, Facultad de Salud, Escuela de Odontología |
| Cali |
| Valle del Cauca Department |
| Colombia |
| Death |
|
| BG001 | Periodontal Prophylaxis (Active Comparator) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity self reported by the participant of this clinical trial. | Number | participants |
|
| Smoking status | Number | participants |
|
| Formal education | Number | participants |
|
| Family monthly income | Economic incomes are presented in United States Dollars (USD). Exchange rate used in this study for the conversion of Colombian Pesos (COP) to USD: 2000 COP = 1 USD. | Number | participants |
|
| Medical insurance | Number | participants |
|
| Endothelium-dependent brachial artery flow-mediated dilatation | Assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated endothelium dependent vasodilatation of the brachial artery (FMD) was determined using the technique previously described by Celermajer et al. (doi: 10.1016/0140-6736(92)93147-F.) and Coretti et al. ( doi: 10.1111/j.1399-302X.1996.tb00183.x.). FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure. | Mean | Standard Deviation | Percentage of dilation |
|
| Serum C-reactive protein (CRP) | Fasting plasma hs-CRP concentrations were determined using a solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens). Baseline serum samples were not collected for one patient randomized into the periodontal prophylaxis group because of inaccessible veins. Number of patients analyzed: Periodontal intervention (n=47); Periodontal prophylaxis (n=54); Total (n=101). | Mean | Standard Deviation | mg/L |
|
| Periodontal Intervention (Experimental) |
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
|
| OG001 | Periodontal Prophylaxis (Active Comparator) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal |
|
|
|
| Secondary | High-sensitivity C-Reactive Protein | The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens). | Posted | Mean | Standard Deviation | mg/L | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
|
|
|
| Secondary | Total Cholesterol | Posted | Mean | Standard Deviation | mg/dL | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
|
|
|
| Secondary | White Blood Cell Count | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
|
|
|
| Secondary | Subgingival Microbiota | Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf). | Posted | Number | participants | 12 weeks post-periodontal therapy |
|
|
|
| Secondary | LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dL | Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy |
|
|
|
| Secondary | Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin) | Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®). Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis. | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| Secondary | Intercellular Adhesion Molecule 1 (ICAM-1) | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| Secondary | Vascular Cell Adhesion Molecule 1 (VCAM-1) | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| Secondary | Myeloperoxidase (MPO) | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| Secondary | Matrix Metalloproteinase-9 (MMP-9) | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| Secondary | Tissue Plasminogen Activator Inhibitor-1 (tPAI-1) | Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis. | Posted | Mean | Standard Deviation | ng/ml | 12 weeks post periodontal therapy |
|
|
|
| 0 |
| 47 |
| 47 |
| 47 |
| EG001 | Periodontal Prophylaxis (Active Comparator) | Periodontal care: - Basic oral hygiene instructions - Supragingival plaque removal | 1 | 55 | 31 | 55 |
|
| Gingival erythema or bleeding | Surgical and medical procedures | Non-systematic Assessment | Visual examination and patient interview 24 h after therapy. These adverse effects are frequently reported together (erythema is frequently a sign of gingival bleeding). |
|
| Periodontal pain (low-intensity) | Surgical and medical procedures | Non-systematic Assessment | Pain intensity was assessed by patient interview 24 h after periodontal therapy. |
|
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| 12 weeks |
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| 12 weeks |
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| 12 weeks |
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| Participants positive for Tf |
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| Participants positive for Pg, Tf and Td |
|
| 12 weeks |
|