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

Primary Purpose

Coronary Heart Disease, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
piezoelectric ultrasonic scaler (frequency of 28-36 KHz)
Gracey curettes
Sponsored by
Government College of Dentistry, Indore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    Periodontal intervention in the form of scaling and root planing by: ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and 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

    No periodontal intervention in any form.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in C-Reactive Protein Level at 6 Months
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.

    Secondary Outcome Measures

    Change From Baseline in C-Reactive Protein Level at 1 Month
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.
    Change From Baseline in C-Reactive Protein Level at 3 Month
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.
    Change From Baseline in Lipid Profile at 1 Month
    Change from baseline in lipid profile assessed at 1 month.
    Change From Baseline in Lipid Profile at 3 Months
    Change from baseline in lipid profile assessed at 3 months.
    Change From Baseline in Lipid Profile at 6 Months.
    Change from baseline in lipid profile assessed at 6 months.
    Change From Baseline WBC Profile at 1 Month
    Change from baseline in white blood cell profile assessed at 1 month.
    Change From Baseline WBC Profile at 3 Months
    Change from baseline in white blood cell profile assessed at 3 months.
    Change From Baseline WBC Profile at 6 Months
    Change from baseline in white blood cell profile assessed at 6 months.
    Systolic Blood Pressure at 1 Month
    Systolic blood pressure at 1 month.
    Systolic Blood Pressure at 3 Months
    Systolic blood pressure at 3 months.
    Systolic Blood Pressure at 6 Months
    Systolic blood pressure at 6 months.
    Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months
    Change from baseline in periodontal parameter- periodontal probing depth at 6 months.
    Change From Baseline Periodontal Parameter- Gingival Index at 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.
    Change From Baseline Periodontal Parameter- Plaque Index at 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.
    Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months
    Change from baseline in periodontal parameter- bleeding on probing at 6 months.
    Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months
    Change from baseline in periodontal parameter- clinical attachment loss at 6 months.
    Diastolic Blood Pressure at 1 Month
    Diastolic blood pressure at 1 month.
    Diastolic Blood Pressure at 3 Months
    Diastolic blood pressure at 3 months.
    Diastolic Blood Pressure at 6 Months
    Diastolic blood pressure at 6 months.

    Full Information

    First Posted
    April 4, 2015
    Last Updated
    January 5, 2017
    Sponsor
    Government College of Dentistry, Indore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02417376
    Brief Title
    Changes in the Risk Factors of Coronary Heart Disease Observed After Scaling and Root Planing
    Official Title
    Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Government College of Dentistry, Indore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Heart Disease, Periodontitis
    Keywords
    Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Active Comparator
    Arm Description
    Periodontal intervention in the form of scaling and root planing by: ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and 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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No periodontal intervention in any form.
    Intervention Type
    Device
    Intervention Name(s)
    piezoelectric ultrasonic scaler (frequency of 28-36 KHz)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Gracey curettes
    Intervention Description
    set of 7 instruments number #1-14
    Primary Outcome Measure Information:
    Title
    Change From Baseline in C-Reactive Protein Level at 6 Months
    Description
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.
    Time Frame
    Baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in C-Reactive Protein Level at 1 Month
    Description
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.
    Time Frame
    Baseline and 1 month
    Title
    Change From Baseline in C-Reactive Protein Level at 3 Month
    Description
    Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.
    Time Frame
    Baseline and 3 months
    Title
    Change From Baseline in Lipid Profile at 1 Month
    Description
    Change from baseline in lipid profile assessed at 1 month.
    Time Frame
    Baseline and 1 month
    Title
    Change From Baseline in Lipid Profile at 3 Months
    Description
    Change from baseline in lipid profile assessed at 3 months.
    Time Frame
    Baseline and 3 months
    Title
    Change From Baseline in Lipid Profile at 6 Months.
    Description
    Change from baseline in lipid profile assessed at 6 months.
    Time Frame
    Baseline and 6 months
    Title
    Change From Baseline WBC Profile at 1 Month
    Description
    Change from baseline in white blood cell profile assessed at 1 month.
    Time Frame
    Baseline and 1 month
    Title
    Change From Baseline WBC Profile at 3 Months
    Description
    Change from baseline in white blood cell profile assessed at 3 months.
    Time Frame
    Baseline and 3 months
    Title
    Change From Baseline WBC Profile at 6 Months
    Description
    Change from baseline in white blood cell profile assessed at 6 months.
    Time Frame
    Baseline and 6 months
    Title
    Systolic Blood Pressure at 1 Month
    Description
    Systolic blood pressure at 1 month.
    Time Frame
    1 month
    Title
    Systolic Blood Pressure at 3 Months
    Description
    Systolic blood pressure at 3 months.
    Time Frame
    3 months
    Title
    Systolic Blood Pressure at 6 Months
    Description
    Systolic blood pressure at 6 months.
    Time Frame
    6 months
    Title
    Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months
    Description
    Change from baseline in periodontal parameter- periodontal probing depth at 6 months.
    Time Frame
    Baseline and 6 months
    Title
    Change From Baseline Periodontal Parameter- Gingival Index at 6 Months
    Description
    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.
    Time Frame
    Baseline and 6 months
    Title
    Change From Baseline Periodontal Parameter- Plaque Index at 6 Months
    Description
    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.
    Time Frame
    Baseline and 6 months
    Title
    Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months
    Description
    Change from baseline in periodontal parameter- bleeding on probing at 6 months.
    Time Frame
    Baseline and 6 months
    Title
    Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months
    Description
    Change from baseline in periodontal parameter- clinical attachment loss at 6 months.
    Time Frame
    Baseline and 6 months
    Title
    Diastolic Blood Pressure at 1 Month
    Description
    Diastolic blood pressure at 1 month.
    Time Frame
    1 month
    Title
    Diastolic Blood Pressure at 3 Months
    Description
    Diastolic blood pressure at 3 months.
    Time Frame
    3 months
    Title
    Diastolic Blood Pressure at 6 Months
    Description
    Diastolic blood pressure at 6 months.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Divya S. Hada, PG Student
    Organizational Affiliation
    Government College of Dentistry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16644317
    Citation
    D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84. doi: 10.1016/j.ahj.2005.06.018.
    Results Reference
    result
    PubMed Identifier
    22966824
    Citation
    Bokhari SA, Khan AA, Butt AK, Azhar M, Hanif M, Izhar M, Tatakis DN. Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial. J Clin Periodontol. 2012 Nov;39(11):1065-74. doi: 10.1111/j.1600-051X.2012.01942.x. Epub 2012 Sep 11.
    Results Reference
    result

    Learn more about this trial

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

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