Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Active Comparator | Periodontal intervention in the form of scaling and root planing by:
|
|
| Control | No Intervention | No periodontal intervention in any form. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| piezoelectric ultrasonic scaler (frequency of 28-36 KHz) | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Divya S. Hada, PG Student | Government College of Dentistry | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16644317 | Result | D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84. doi: 10.1016/j.ahj.2005.06.018. | |
| 22966824 | Result | Bokhari SA, Khan AA, Butt AK, Azhar M, Hanif M, Izhar M, Tatakis DN. Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial. J Clin Periodontol. 2012 Nov;39(11):1065-74. doi: 10.1111/j.1600-051X.2012.01942.x. Epub 2012 Sep 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Total 100 CHD patients recruited from Cardiology department of MY hospital, Indore, were evaluated at department of Periodontology, GDC Indore, for final selection.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Periodontal intervention in the form of scaling and root planing by:
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 |
| FG001 | Control | No periodontal intervention in any form. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All are CHD patients - never smoker, without any other systemic disease
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Periodontal intervention in the form of scaling and root planing by:
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 |
| 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 | 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. | All patients suffered from CHD and Periodontitis both. | Posted | Mean | Standard Deviation | mg/L | Baseline and 6 months |
|
6 months
Adverse events were not collected
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Periodontal intervention in the form of scaling and root planing by:
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 |
Not provided
Not provided
populations were taken only from a single center, the dropout, strict inclusion criteria, total number of patients to be included in the study was limited, influence of medical drug management of CHD not taken into consideration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Divya Singh Hada | GCD Indore | +918720898289 | dr_dshada@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gracey curettes | Device | set of 7 instruments number #1-14 |
|
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 |
| BG001 | Control | No periodontal intervention in any form. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | No periodontal intervention in any form. |
|
|
| 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. | Posted | Mean | Standard Deviation | mg/L | Baseline and 1 month |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/L | Baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in Lipid Profile at 1 Month | Change from baseline in lipid profile assessed at 1 month. | Posted | Mean | Standard Deviation | mg/dl | Baseline and 1 month |
|
|
|
| Secondary | Change From Baseline in Lipid Profile at 3 Months | Change from baseline in lipid profile assessed at 3 months. | Posted | Mean | Standard Deviation | mg/dl | Baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in Lipid Profile at 6 Months. | Change from baseline in lipid profile assessed at 6 months. | Posted | Mean | Standard Deviation | mg/dl | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline WBC Profile at 1 Month | Change from baseline in white blood cell profile assessed at 1 month. | Posted | Mean | Standard Deviation | per cmm | Baseline and 1 month |
|
|
|
| Secondary | Change From Baseline WBC Profile at 3 Months | Change from baseline in white blood cell profile assessed at 3 months. | Posted | Mean | Standard Deviation | per cmm | Baseline and 3 months |
|
|
|
| Secondary | Change From Baseline WBC Profile at 6 Months | Change from baseline in white blood cell profile assessed at 6 months. | Posted | Mean | Standard Deviation | per cmm | Baseline and 6 months |
|
|
|
| Secondary | Systolic Blood Pressure at 1 Month | Systolic blood pressure at 1 month. | Posted | Mean | Standard Deviation | mmHg | 1 month |
|
|
|
| Secondary | Systolic Blood Pressure at 3 Months | Systolic blood pressure at 3 months. | Posted | Mean | Standard Deviation | mmHg | 3 months |
|
|
|
| Secondary | Systolic Blood Pressure at 6 Months | Systolic blood pressure at 6 months. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months | Change from baseline in periodontal parameter- periodontal probing depth at 6 months. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months | Change from baseline in periodontal parameter- bleeding on probing at 6 months. | Posted | Mean | Standard Deviation | percentage of sites | Baseline and 6 months |
|
|
|
| Secondary | Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months | Change from baseline in periodontal parameter- clinical attachment loss at 6 months. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
|
|
|
| Secondary | Diastolic Blood Pressure at 1 Month | Diastolic blood pressure at 1 month. | Posted | Mean | Standard Deviation | mmHg | 1 month |
|
|
|
| Secondary | Diastolic Blood Pressure at 3 Months | Diastolic blood pressure at 3 months. | Posted | Mean | Standard Deviation | mmHg | 3 months |
|
|
|
| Secondary | Diastolic Blood Pressure at 6 Months | Diastolic blood pressure at 6 months. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | No periodontal intervention in any form. | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |