N/A
N=70
Changes in the Risk Factors of Coronary Heart Disease Observed After Scaling and Root Planing
Coronary Heart Disease · Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT02417376 ↗Enrolled (actual)
70
Serious AEs
—
Results posted
Feb 2017
Primary outcome: Primary: Change From Baseline in C-Reactive Protein Level at 6 Months — 6.30; 4.94 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- piezoelectric ultrasonic scaler (frequency of 28-36 KHz) (Device); Gracey curettes (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Government College of Dentistry, Indore
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in C-Reactive Protein Level at 6 Months |
6.30; 4.94 | — |
| SECONDARY Change From Baseline in C-Reactive Protein Level at 1 Month |
6.21; 4.31 | — |
| SECONDARY Change From Baseline in C-Reactive Protein Level at 3 Month |
6.22; 4.09 | — |
| SECONDARY Change From Baseline in Lipid Profile at 1 Month |
35.67; 25.20 | — |
| SECONDARY Change From Baseline in Lipid Profile at 3 Months |
33.70; 26.08 | — |
| SECONDARY Change From Baseline in Lipid Profile at 6 Months. |
32.39; 26.24 | — |
| SECONDARY Change From Baseline WBC Profile at 1 Month |
8023.33; 7448.00 | — |
| SECONDARY Change From Baseline WBC Profile at 3 Months |
7750; 8260 | — |
| SECONDARY Change From Baseline WBC Profile at 6 Months |
7553.33; 8384.00 | — |
| SECONDARY Systolic Blood Pressure at 1 Month |
130.00; 120.56 | — |
| SECONDARY Systolic Blood Pressure at 3 Months |
125.47; 118.56 | — |
| SECONDARY Systolic Blood Pressure at 6 Months |
123.70; 120.88 | — |
| SECONDARY Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months |
1.78; 1.86 | — |
| SECONDARY Change From Baseline Periodontal Parameter- Gingival Index at 6 Months |
0.49; 1.32 | — |
| SECONDARY Change From Baseline Periodontal Parameter- Plaque Index at 6 Months |
0.80; 1.15 | — |
| SECONDARY Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months |
38.97; 83.20 | — |
| SECONDARY Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months |
2.85; 2.78 | — |
| SECONDARY Diastolic Blood Pressure at 1 Month |
83.87; 76 | — |
| SECONDARY Diastolic Blood Pressure at 3 Months |
80.67; 76.48 | — |
| SECONDARY Diastolic Blood Pressure at 6 Months |
80.07; 76.64 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02417376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.