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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
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.
set of 7 instruments number #1-14
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.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: Baseline and 3 months
Change From Baseline in Lipid Profile at 1 Month
Change from baseline in lipid profile assessed at 1 month.
Time frame: Baseline and 1 month
Change From Baseline in Lipid Profile at 3 Months
Change from baseline in lipid profile assessed at 3 months.
Time frame: Baseline and 3 months
Change From Baseline in Lipid Profile at 6 Months.
Change from baseline in lipid profile assessed at 6 months.
Time frame: Baseline and 6 months
Change From Baseline WBC Profile at 1 Month
Change from baseline in white blood cell profile assessed at 1 month.
Time frame: Baseline and 1 month
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Change From Baseline WBC Profile at 3 Months
Change from baseline in white blood cell profile assessed at 3 months.
Time frame: Baseline and 3 months
Change From Baseline WBC Profile at 6 Months
Change from baseline in white blood cell profile assessed at 6 months.
Time frame: Baseline and 6 months
Systolic Blood Pressure at 1 Month
Systolic blood pressure at 1 month.
Time frame: 1 month
Systolic Blood Pressure at 3 Months
Systolic blood pressure at 3 months.
Time frame: 3 months
Systolic Blood Pressure at 6 Months
Systolic blood pressure at 6 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
Diastolic Blood Pressure at 1 Month
Diastolic blood pressure at 1 month.
Time frame: 1 month
Diastolic Blood Pressure at 3 Months
Diastolic blood pressure at 3 months.
Time frame: 3 months
Diastolic Blood Pressure at 6 Months
Diastolic blood pressure at 6 months.
Time frame: 6 months