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

Not Applicable

Completed

• Conditions: Coronary Heart Disease; Periodontitis
• Interventions: Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz); Device: Gracey curettes

• Registration Number: NCT02417376
• Lead Sponsor: Government College of Dentistry, Indore

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-04-04
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Results First Submitted: 2016-02-25
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-05
• Last Update Submitted: 2017-01-05
• Results First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Gracey curettes	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
Experimental	piezoelectric ultrasonic scaler (frequency of 28-36 KHz)	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Systolic Blood Pressure at 3 Months	3 months	Systolic blood pressure at 3 months.
Diastolic Blood Pressure at 6 Months	6 months	Diastolic blood pressure 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 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- 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 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.
Diastolic Blood Pressure at 3 Months	3 months	Diastolic blood pressure 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 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.
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 Periodontal Parameter- Periodontal Probing Depth at 6 Months	Baseline and 6 months	Change from baseline in periodontal parameter- periodontal probing depth at 6 months.
Systolic Blood Pressure at 6 Months	6 months	Systolic blood pressure at 6 months.
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.
Diastolic Blood Pressure at 1 Month	1 month	Diastolic blood pressure at 1 month.
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.