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

G

Government College of Dentistry, Indore

Status

Completed

Conditions

Periodontitis
Coronary Heart Disease

Treatments

Device: Gracey curettes
Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz)

Study type

Interventional

Funder types

Other

Identifiers

NCT02417376
GCD-010/55/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Experimental
Active Comparator group
Description:
Periodontal intervention in the form of scaling and root planing by: 1. ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and 2. 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
Treatment:
Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz)
Device: Gracey curettes
Control
No Intervention group
Description:
No periodontal intervention in any form.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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