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
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
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
NCT ID
NCT02417376
First Posted
April 4, 2015
Last Updated
January 5, 2017
Sponsor
Government College of Dentistry, Indore
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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