Clinical trial NCT02417376: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Periodontitis
Keywords: Coronary heart disease
Periodontitis
C-reactive protein
Blood pressure
Lead sponsor: Government College of Dentistry, Indore
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in C-Reactive Protein Level at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in C-Reactive Protein Level at 1 Month
timeFrame: Baseline and 1 month
measure: Change From Baseline in C-Reactive Protein Level at 3 Month
timeFrame: Baseline and 3 months
measure: Change From Baseline in Lipid Profile at 1 Month
timeFrame: Baseline and 1 month
measure: Change From Baseline in Lipid Profile at 3 Months
timeFrame: Baseline and 3 months
measure: Change From Baseline in Lipid Profile at 6 Months.
timeFrame: Baseline and 6 months
measure: Change From Baseline WBC Profile at 1 Month
timeFrame: Baseline and 1 month
measure: Change From Baseline WBC Profile at 3 Months
timeFrame: Baseline and 3 months
measure: Change From Baseline WBC Profile at 6 Months
timeFrame: Baseline and 6 months
measure: Systolic Blood Pressure at 1 Month
timeFrame: 1 month
measure: Systolic Blood Pressure at 3 Months
timeFrame: 3 months
measure: Systolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline Periodontal Parameter- Gingival Index at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline Periodontal Parameter- Plaque Index at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months
timeFrame: Baseline and 6 months
measure: Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months
timeFrame: Baseline and 6 months
measure: Diastolic Blood Pressure at 1 Month
timeFrame: 1 month
measure: Diastolic Blood Pressure at 3 Months
timeFrame: 3 months
measure: Diastolic Blood Pressure at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Government College of Dentistry
name: Divya S. Hada, PG Student
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.