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Completed

NCT Number: NCT02417376

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Mouth Diseases Myocardial Ischemia Periodontal Diseases Periodontitis Stomatognathic Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

piezoelectric ultrasonic scaler (frequency of 28-36 KHz)

Device

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

Device

set of 7 instruments number #1-14

Primary outcomes

  1. 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

  1. Change From Baseline in C-Reactive Protein Level at 1 Month

    Time frame: Baseline and 1 month

    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.

  2. Change From Baseline in C-Reactive Protein Level at 3 Month

    Time frame: Baseline and 3 months

    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.

  3. Change From Baseline in Lipid Profile at 1 Month

    Time frame: Baseline and 1 month

    Change from baseline in lipid profile assessed at 1 month.

  4. Change From Baseline in Lipid Profile at 3 Months

    Time frame: Baseline and 3 months

    Change from baseline in lipid profile assessed at 3 months.

  5. Change From Baseline in Lipid Profile at 6 Months.

    Time frame: Baseline and 6 months

    Change from baseline in lipid profile assessed at 6 months.

  6. Change From Baseline WBC Profile at 1 Month

    Time frame: Baseline and 1 month

    Change from baseline in white blood cell profile assessed at 1 month.

  7. Change From Baseline WBC Profile at 3 Months

    Time frame: Baseline and 3 months

    Change from baseline in white blood cell profile assessed at 3 months.

  8. Change From Baseline WBC Profile at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in white blood cell profile assessed at 6 months.

  9. Systolic Blood Pressure at 1 Month

    Time frame: 1 month

    Systolic blood pressure at 1 month.

  10. Systolic Blood Pressure at 3 Months

    Time frame: 3 months

    Systolic blood pressure at 3 months.

  11. Systolic Blood Pressure at 6 Months

    Time frame: 6 months

    Systolic blood pressure at 6 months.

  12. Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in periodontal parameter- periodontal probing depth at 6 months.

  13. Change From Baseline Periodontal Parameter- Gingival Index at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in periodontal parameter- gingival index at 6 months. Scale ranges for Total Gingival Index - Minimum score (0) and maximum score (3).

    Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded.

  14. Change From Baseline Periodontal Parameter- Plaque Index at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in periodontal parameter- plaque index at 6 months. Scale ranges for Total Plaque Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded.

  15. Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in periodontal parameter- bleeding on probing at 6 months.

  16. Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months

    Time frame: Baseline and 6 months

    Change from baseline in periodontal parameter- clinical attachment loss at 6 months.

  17. Diastolic Blood Pressure at 1 Month

    Time frame: 1 month

    Diastolic blood pressure at 1 month.

  18. Diastolic Blood Pressure at 3 Months

    Time frame: 3 months

    Diastolic blood pressure at 3 months.

  19. Diastolic Blood Pressure at 6 Months

    Time frame: 6 months

    Diastolic blood pressure at 6 months.

Sponsors and collaborators

Lead sponsor

Government College of Dentistry, Indore

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2015
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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