Changes in the Risk Factors of Coronary Heart Disease Observed After Scaling and Root Planing

Study Overview
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Brief Summary
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The purpose of this study is to determine whether scaling and root planing as a periodontal intervention helps in improving the overall health of patients suffering from coronary heart disease.

Detailed Description
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This study is a randomized, outcome assessor blinded, parallel group, trial to evaluate the effect of non surgical periodontal treatment in the form of scaling and root planing on coronary heart disease patients. 70 clinically defined coronary heart disease (CHD) patients with mild to moderate periodontitis, were allocated into two groups- experimental and control, in a ratio of 1:1. Scaling and root planing was provided as the intervention to the experimental group. To the control group no periodontal intervention in any form was provided. The primary outcome assessed is the changes in C-reactive protein level at baseline and after 1, 3, and 6 months of periodontal intervention. The secondary outcomes assessed are lipid profile, white blood cells (WBC) profile, and blood pressure (systolic and diastolic) at baseline and after 1, 3, and 6 months of periodontal intervention. Periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), periodontal probing depth (PPD), and clinical attachment loss (CAL) is also assessed at baseline and after 6 months. All these parameters were also compared with their corresponding values in the control group.

Official Title
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Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial

Conditions
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Coronary Heart Disease, Periodontitis

Intervention / Treatment
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* Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz)
* Device: Gracey curettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female > 35 yrs of age Clinically diagnosed stable CHD cases No other systemic disease Non-smoker Advanced chronic gingivitis and mild to moderate chronic periodontitis (≥ 4 teeth with probing depth ≤ 5 mm) and ≥ 14 teeth (excluding third molars) No periodontal therapy in the last 12 months. Exclusion Criteria: Not fulfilling criteria of the defined CHD case Present smoker Pregnant or lactating females Suffering from any other systemic disease like diabetes Taking systemic antibiotic therapy in the last 3 months Advanced chronic periodontitis (probing depth > 5mm) and <14 teeth (excluding third molars) Received any periodontal therapy within last 12 months.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental<br>Periodontal intervention in the form of scaling and root planing by: ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours | Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz)<br>* Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.<br>Device: Gracey curettes<br>* set of 7 instruments number #1-14<br>|
| No Intervention: Control<br>No periodontal intervention in any form. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in C-Reactive Protein Level at 6 Months | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in C-Reactive Protein Level at 1 Month | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month. | Baseline and 1 month | 
| Change From Baseline in C-Reactive Protein Level at 3 Month | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months. | Baseline and 3 months | 
| Change From Baseline in Lipid Profile at 1 Month | Change from baseline in lipid profile assessed at 1 month. | Baseline and 1 month | 
| Change From Baseline in Lipid Profile at 3 Months | Change from baseline in lipid profile assessed at 3 months. | Baseline and 3 months | 
| Change From Baseline in Lipid Profile at 6 Months. | Change from baseline in lipid profile assessed at 6 months. | Baseline and 6 months | 
| Change From Baseline WBC Profile at 1 Month | Change from baseline in white blood cell profile assessed at 1 month. | Baseline and 1 month | 
| Change From Baseline WBC Profile at 3 Months | Change from baseline in white blood cell profile assessed at 3 months. | Baseline and 3 months | 
| Change From Baseline WBC Profile at 6 Months | Change from baseline in white blood cell profile assessed at 6 months. | Baseline and 6 months | 
| Systolic Blood Pressure at 1 Month | Systolic blood pressure at 1 month. | 1 month | 
| Systolic Blood Pressure at 3 Months | Systolic blood pressure at 3 months. | 3 months | 
| Systolic Blood Pressure at 6 Months | Systolic blood pressure at 6 months. | 6 months | 
| Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months | Change from baseline in periodontal parameter- periodontal probing depth at 6 months. | Baseline and 6 months | 
| Change From Baseline Periodontal Parameter- Gingival Index at 6 Months | Change from baseline in periodontal parameter- gingival index at 6 months. Scale ranges for Total Gingival Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded. | Baseline and 6 months | 
| Change From Baseline Periodontal Parameter- Plaque Index at 6 Months | Change from baseline in periodontal parameter- plaque index at 6 months. Scale ranges for Total Plaque Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded. | Baseline and 6 months | 
| Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months | Change from baseline in periodontal parameter- bleeding on probing at 6 months. | Baseline and 6 months | 
| Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months | Change from baseline in periodontal parameter- clinical attachment loss at 6 months. | Baseline and 6 months | 
| Diastolic Blood Pressure at 1 Month | Diastolic blood pressure at 1 month. | 1 month | 
| Diastolic Blood Pressure at 3 Months | Diastolic blood pressure at 3 months. | 3 months | 
| Diastolic Blood Pressure at 6 Months | Diastolic blood pressure at 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure