Evaluation of periodontal status among patients with coronary heart disease- effect of scaling and root planing on their periodontal and cardiovascular (clinical and biochemical) status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- C-reactive protein, lipid profile, blood pressure, WBC count
Study Overview
Brief Summary
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 CHD patients with periodontitis, were allocated into two groups- experimental and control. Scaling and root planing was provided as the intervention to the experimental group. The primary outcome are the changes in C-reactive level and systolic blood pressure at the end of 6 months. The secondary outcomes are blood pressure, pulse, respiratory rate, C-reactive protein, lipid profile, WBC profile at baseline, 1, 3, and 6 months. Periodontal parameters including PI, GI, BOP, PPD, and CAL is also assessed at baseline and 6 months. All these parameters were also compared with their corresponding values in the control group.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male/Female more than 35 yrs of age, clinically diagnosed stable CHD cases, including stable angina, non ST elevation myocardial infarction, ST elevation myocardial infarction, not suffering from any other systemic disease, non-smoker, more than 14 teeth (excluding third molars), with advanced chronic gingivitis and mild to moderate chronic periodontitis (more than or equal to 4 teeth with probing depth less than or equal to 5mm), not undergone any periodontal therapy in the last 12 months formed the basis of inclusion.
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, less than 14 teeth (excluding third molars), with advanced chronic periodontitis (probing depth > 5mm), received any periodontal therapy within last 12 months.
Outcomes
Primary Outcomes
C-reactive protein, lipid profile, blood pressure, WBC count
Time Frame: 6 months
Secondary Outcomes
- C reactive protein, WBC count, lipid profile, BP, periodontal parameters(Baseline, 01 month, 03 month)