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

Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Coronary Heart Disease
• Intervention / Treatment: Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz); Device: Gracey curettes

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental; Periodontal intervention in the form of scaling and root planing by: ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and; 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	Device: 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.; Device: Gracey curettes; set of 7 instruments number #1-14
No Intervention: Control; No periodontal intervention in any form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Government College of Dentistry, Indore
• Investigators: Principal Investigator: Divya S. Hada, PG Student, Government College of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 4, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Coronary heart disease; Periodontitis; Blood pressure; C-reactive protein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Periodontitis
• Other Study ID Numbers: GCD-010/55/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO