Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Government College of Dentistry, Indore
- Enrollment
- 70
- Primary Endpoint
- Change From Baseline in C-Reactive Protein Level at 6 Months
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Dr DIVYA SINGH HADA
Post-graduate Student
Government College of Dentistry, Indore
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change From Baseline in C-Reactive Protein Level at 6 Months
Time Frame: Baseline and 6 months
Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.
Secondary Outcomes
- Systolic Blood Pressure at 3 Months(3 months)
- Change From Baseline WBC Profile at 1 Month(Baseline and 1 month)
- Change From Baseline in C-Reactive Protein Level at 1 Month(Baseline and 1 month)
- Change From Baseline Periodontal Parameter- Gingival Index at 6 Months(Baseline and 6 months)
- Change From Baseline Periodontal Parameter- Plaque Index at 6 Months(Baseline and 6 months)
- Change From Baseline in C-Reactive Protein Level at 3 Month(Baseline and 3 months)
- Diastolic Blood Pressure at 3 Months(3 months)
- Change From Baseline in Lipid Profile at 6 Months.(Baseline and 6 months)
- Change From Baseline WBC Profile at 3 Months(Baseline and 3 months)
- Change From Baseline WBC Profile at 6 Months(Baseline and 6 months)
- Systolic Blood Pressure at 1 Month(1 month)
- Change From Baseline in Lipid Profile at 1 Month(Baseline and 1 month)
- Change From Baseline in Lipid Profile at 3 Months(Baseline and 3 months)
- Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months(Baseline and 6 months)
- Systolic Blood Pressure at 6 Months(6 months)
- Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months(Baseline and 6 months)
- Diastolic Blood Pressure at 1 Month(1 month)
- Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months(Baseline and 6 months)
- Diastolic Blood Pressure at 6 Months(6 months)