Coronary Heart Disease, Periodontitis
Conditions
Keywords
Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure
Brief summary
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
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.
Interventions
DEVICEpiezoelectric ultrasonic scaler (frequency of 28-36 KHz)
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.
DEVICEGracey curettes
set of 7 instruments number #1-14
Sponsors
Government College of Dentistry, Indore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in C-Reactive Protein Level at 6 Months | Baseline and 6 months | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in C-Reactive Protein Level at 3 Month | Baseline and 3 months | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months. |
| Change From Baseline in Lipid Profile at 1 Month | Baseline and 1 month | Change from baseline in lipid profile assessed at 1 month. |
| Change From Baseline in Lipid Profile at 3 Months | Baseline and 3 months | Change from baseline in lipid profile assessed at 3 months. |
| Change From Baseline in Lipid Profile at 6 Months. | Baseline and 6 months | Change from baseline in lipid profile assessed at 6 months. |
| Change From Baseline WBC Profile at 1 Month | Baseline and 1 month | Change from baseline in white blood cell profile assessed at 1 month. |
| Change From Baseline WBC Profile at 3 Months | Baseline and 3 months | Change from baseline in white blood cell profile assessed at 3 months. |
| Change From Baseline WBC Profile at 6 Months | Baseline and 6 months | Change from baseline in white blood cell profile assessed at 6 months. |
| Systolic Blood Pressure at 1 Month | 1 month | Systolic blood pressure at 1 month. |
| Systolic Blood Pressure at 3 Months | 3 months | Systolic blood pressure at 3 months. |
| Change From Baseline in C-Reactive Protein Level at 1 Month | Baseline and 1 month | Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month. |
| Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months | Baseline and 6 months | Change from baseline in periodontal parameter- periodontal probing depth at 6 months. |
| Change From Baseline Periodontal Parameter- Gingival Index at 6 Months | Baseline and 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. |
| Change From Baseline Periodontal Parameter- Plaque Index at 6 Months | Baseline and 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. |
| Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months | Baseline and 6 months | Change from baseline in periodontal parameter- bleeding on probing at 6 months. |
| Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months | Baseline and 6 months | Change from baseline in periodontal parameter- clinical attachment loss at 6 months. |
| Diastolic Blood Pressure at 1 Month | 1 month | Diastolic blood pressure at 1 month. |
| Diastolic Blood Pressure at 3 Months | 3 months | Diastolic blood pressure at 3 months. |
| Diastolic Blood Pressure at 6 Months | 6 months | Diastolic blood pressure at 6 months. |
| Systolic Blood Pressure at 6 Months | 6 months | Systolic blood pressure at 6 months. |
Participant flow
Recruitment details
Total 100 CHD patients recruited from Cardiology department of MY hospital, Indore, were evaluated at department of Periodontology, GDC Indore, for final selection.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Periodontal intervention in the form of scaling and root planing by:
1. ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and
2. 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
piezoelectric ultrasonic scaler (frequency of 28-36 KHz): 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.
Gracey curettes: set of 7 instruments number #1-14 | 35 |
| Control No periodontal intervention in any form. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Continuous | 60.43 years STANDARD_DEVIATION 10.31 | 60.21 years STANDARD_DEVIATION 9.23 | 60.30 years STANDARD_DEVIATION 9.56 |
| Gender Female | 12 Participants | 9 Participants | 21 Participants |
| Gender Male | 23 Participants | 26 Participants | 49 Participants |
| Region of Enrollment India | 35 participants | 35 participants | 70 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: All patients suffered from CHD and Periodontitis both.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in C-Reactive Protein Level at 6 Months | 6.30 mg/L | Standard Deviation 7.53 |
| Control | Change From Baseline in C-Reactive Protein Level at 6 Months | 4.94 mg/L | Standard Deviation 2.04 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in C-Reactive Protein Level at 1 Month | 6.21 mg/L | Standard Deviation 1.92 |
| Control | Change From Baseline in C-Reactive Protein Level at 1 Month | 4.31 mg/L | Standard Deviation 2.43 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in C-Reactive Protein Level at 3 Month | 6.22 mg/L | Standard Deviation 3.64 |
| Control | Change From Baseline in C-Reactive Protein Level at 3 Month | 4.09 mg/L | Standard Deviation 1.82 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in Lipid Profile at 1 Month | 35.67 mg/dl | Standard Deviation 21.67 |
| Control | Change From Baseline in Lipid Profile at 1 Month | 25.20 mg/dl | Standard Deviation 6.48 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in Lipid Profile at 3 Months | 33.70 mg/dl | Standard Deviation 19.53 |
| Control | Change From Baseline in Lipid Profile at 3 Months | 26.08 mg/dl | Standard Deviation 7.14 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline in Lipid Profile at 6 Months. | 32.39 mg/dl | Standard Deviation 18.43 |
| Control | Change From Baseline in Lipid Profile at 6 Months. | 26.24 mg/dl | Standard Deviation 6.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months | 38.97 percentage of sites | Standard Deviation 12.93 |
| Control | Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months | 83.20 percentage of sites | Standard Deviation 13.02 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months | 2.85 mm | Standard Deviation 0.59 |
| Control | Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months | 2.78 mm | Standard Deviation 0.64 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline Periodontal Parameter- Gingival Index at 6 Months | 0.49 Scores on a scale | Standard Deviation 0.19 |
| Control | Change From Baseline Periodontal Parameter- Gingival Index at 6 Months | 1.32 Scores on a scale | Standard Deviation 0.13 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months | 1.78 mm | Standard Deviation 0.54 |
| Control | Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months | 1.86 mm | Standard Deviation 0.31 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline Periodontal Parameter- Plaque Index at 6 Months | 0.80 Scores on a scale | Standard Deviation 0.62 |
| Control | Change From Baseline Periodontal Parameter- Plaque Index at 6 Months | 1.15 Scores on a scale | Standard Deviation 0.14 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline WBC Profile at 1 Month | 8023.33 per cmm | Standard Deviation 2463.06 |
| Control | Change From Baseline WBC Profile at 1 Month | 7448.00 per cmm | Standard Deviation 912.01 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline WBC Profile at 3 Months | 7750 per cmm | Standard Deviation 1727.62 |
| Control | Change From Baseline WBC Profile at 3 Months | 8260 per cmm | Standard Deviation 1830.76 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Change From Baseline WBC Profile at 6 Months | 7553.33 per cmm | Standard Deviation 1634.91 |
| Control | Change From Baseline WBC Profile at 6 Months | 8384.00 per cmm | Standard Deviation 1171.07 |
Secondary
Diastolic Blood Pressure at 1 Month
Diastolic blood pressure at 1 month.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Diastolic Blood Pressure at 1 Month | 83.87 mmHg | Standard Deviation 10.51 |
| Control | Diastolic Blood Pressure at 1 Month | 76 mmHg | Standard Deviation 9.98 |
Secondary
Diastolic Blood Pressure at 3 Months
Diastolic blood pressure at 3 months.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Diastolic Blood Pressure at 3 Months | 80.67 mmHg | Standard Deviation 9.66 |
| Control | Diastolic Blood Pressure at 3 Months | 76.48 mmHg | Standard Deviation 7.9 |
Secondary
Diastolic Blood Pressure at 6 Months
Diastolic blood pressure at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Diastolic Blood Pressure at 6 Months | 80.07 mmHg | Standard Deviation 9.12 |
| Control | Diastolic Blood Pressure at 6 Months | 76.64 mmHg | Standard Deviation 7.78 |
Secondary
Systolic Blood Pressure at 1 Month
Systolic blood pressure at 1 month.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Systolic Blood Pressure at 1 Month | 130.00 mmHg | Standard Deviation 19.69 |
| Control | Systolic Blood Pressure at 1 Month | 120.56 mmHg | Standard Deviation 17.6 |
Secondary
Systolic Blood Pressure at 3 Months
Systolic blood pressure at 3 months.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Systolic Blood Pressure at 3 Months | 125.47 mmHg | Standard Deviation 16.27 |
| Control | Systolic Blood Pressure at 3 Months | 118.56 mmHg | Standard Deviation 14.23 |
Secondary
Systolic Blood Pressure at 6 Months
Systolic blood pressure at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Systolic Blood Pressure at 6 Months | 123.70 mmHg | Standard Deviation 15.72 |
| Control | Systolic Blood Pressure at 6 Months | 120.88 mmHg | Standard Deviation 14.56 |