Trial Outcomes & Findings for Changes in the Risk Factors of Coronary Heart Disease Observed After Scaling and Root Planing (NCT NCT02417376)

NCT ID: NCT02417376

Last Updated: 2017-02-24

Results Overview

Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2017-02-24

Participant Flow

Total 100 CHD patients recruited from Cardiology department of MY hospital, Indore, were evaluated at department of Periodontology, GDC Indore, for final selection.

Participant milestones

Measure	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	Control No periodontal intervention in any form.
Overall Study STARTED	35	35
Overall Study COMPLETED	30	25
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.	Total n=70 Participants Total of all reporting groups
Age, Continuous	60.43 years STANDARD_DEVIATION 10.31 • n=5 Participants	60.21 years STANDARD_DEVIATION 9.23 • n=7 Participants	60.30 years STANDARD_DEVIATION 9.56 • n=5 Participants
Gender Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Gender Male	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment India	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: All patients suffered from CHD and Periodontitis both.

Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in C-Reactive Protein Level at 6 Months	6.30 mg/L Standard Deviation 7.53	4.94 mg/L Standard Deviation 2.04

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in C-Reactive Protein Level at 1 Month	6.21 mg/L Standard Deviation 1.92	4.31 mg/L Standard Deviation 2.43

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in C-Reactive Protein Level at 3 Month	6.22 mg/L Standard Deviation 3.64	4.09 mg/L Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in lipid profile assessed at 1 month.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in Lipid Profile at 1 Month	35.67 mg/dl Standard Deviation 21.67	25.20 mg/dl Standard Deviation 6.48

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in lipid profile assessed at 3 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in Lipid Profile at 3 Months	33.70 mg/dl Standard Deviation 19.53	26.08 mg/dl Standard Deviation 7.14

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in lipid profile assessed at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline in Lipid Profile at 6 Months.	32.39 mg/dl Standard Deviation 18.43	26.24 mg/dl Standard Deviation 6.50

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in white blood cell profile assessed at 1 month.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline WBC Profile at 1 Month	8023.33 per cmm Standard Deviation 2463.06	7448.00 per cmm Standard Deviation 912.01

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in white blood cell profile assessed at 3 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline WBC Profile at 3 Months	7750 per cmm Standard Deviation 1727.62	8260 per cmm Standard Deviation 1830.76

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in white blood cell profile assessed at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline WBC Profile at 6 Months	7553.33 per cmm Standard Deviation 1634.91	8384.00 per cmm Standard Deviation 1171.07

SECONDARY outcome

Timeframe: 1 month

Systolic blood pressure at 1 month.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Systolic Blood Pressure at 1 Month	130.00 mmHg Standard Deviation 19.69	120.56 mmHg Standard Deviation 17.60

SECONDARY outcome

Timeframe: 3 months

Systolic blood pressure at 3 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Systolic Blood Pressure at 3 Months	125.47 mmHg Standard Deviation 16.27	118.56 mmHg Standard Deviation 14.23

SECONDARY outcome

Timeframe: 6 months

Systolic blood pressure at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Systolic Blood Pressure at 6 Months	123.70 mmHg Standard Deviation 15.72	120.88 mmHg Standard Deviation 14.56

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in periodontal parameter- periodontal probing depth at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months	1.78 mm Standard Deviation 0.54	1.86 mm Standard Deviation 0.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline Periodontal Parameter- Gingival Index at 6 Months	0.49 Scores on a scale Standard Deviation 0.19	1.32 Scores on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline Periodontal Parameter- Plaque Index at 6 Months	0.80 Scores on a scale Standard Deviation 0.62	1.15 Scores on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in periodontal parameter- bleeding on probing at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months	38.97 percentage of sites Standard Deviation 12.93	83.20 percentage of sites Standard Deviation 13.02

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in periodontal parameter- clinical attachment loss at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months	2.85 mm Standard Deviation 0.59	2.78 mm Standard Deviation 0.64

SECONDARY outcome

Timeframe: 1 month

Diastolic blood pressure at 1 month.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Diastolic Blood Pressure at 1 Month	83.87 mmHg Standard Deviation 10.51	76 mmHg Standard Deviation 9.98

SECONDARY outcome

Timeframe: 3 months

Diastolic blood pressure at 3 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Diastolic Blood Pressure at 3 Months	80.67 mmHg Standard Deviation 9.66	76.48 mmHg Standard Deviation 7.90

SECONDARY outcome

Timeframe: 6 months

Diastolic blood pressure at 6 months.

Outcome measures

Measure	Experimental n=35 Participants 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	Control n=35 Participants No periodontal intervention in any form.
Diastolic Blood Pressure at 6 Months	80.07 mmHg Standard Deviation 9.12	76.64 mmHg Standard Deviation 7.78

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Divya Singh Hada

GCD Indore

Phone: +918720898289

Email: dr_dshada@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place