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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417376
• Other study ID #: GCD-010/55/2013
• Status: Completed
• Phase: N/A
• First received: April 4, 2015
• Last updated: April 14, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Government College of Dentistry, Indore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Periodontitis

Intervention

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.
• Gracey curettes
set of 7 instruments number #1-14

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government College of Dentistry, Indore

References & Publications (2)

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.2012.01 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 6 months	No
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.	Baseline and 1 month	No
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.	Baseline and 3 months	No
Secondary	Change from baseline in lipid profile at 1 month	Change from baseline in lipid profile assessed at 1 month.	Baseline and 1 month	No
Secondary	Change from baseline in lipid profile at 3 months	Change from baseline in lipid profile assessed at 3 months.	Baseline and 3 months	No
Secondary	Change from baseline in lipid profile at 6 months.	Change from baseline in lipid profile assessed at 6 months.	Baseline and 6 months	No
Secondary	Change from baseline WBC profile at 1 month	Change from baseline in white blood cell profile assessed at 1 month.	Baseline and 1 month	No
Secondary	Change from baseline WBC profile at 3 months	Change from baseline in white blood cell profile assessed at 3 months.	Baseline and 3 months	No
Secondary	Change from baseline WBC profile at 6 months	Change from baseline in white blood cell profile assessed at 6 months.	Baseline and 6 months	No
Secondary	Change from baseline blood pressure at 1 month	Change from baseline in blood pressure (systolic and diastolic) at 1 month.	Baseline and 1 month	No
Secondary	Change from baseline blood pressure at 3 months	Change from baseline in blood pressure (systolic and diastolic) at 3 months.	Baseline and 3 months	No
Secondary	Change from baseline blood pressure at 6 months	Change from baseline in blood pressure (systolic and diastolic) at 6 months.	Baseline and 6 months	No
Secondary	Change from baseline periodontal parameters at 6 months	Change from baseline in periodontal parameters (gingival index, plaque index, bleeding on probing, periodontal probing depth and clinical attachment loss) at 6 months.	Baseline and 6 months	No