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

NCT ID: NCT02417376

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-10-31

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.

Conditions

Coronary Heart Disease; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

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

Group Type: ACTIVE_COMPARATOR

piezoelectric ultrasonic scaler (frequency of 28-36 KHz)

Intervention Type: 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

Intervention Type: DEVICE

set of 7 instruments number #1-14

Control

No periodontal intervention in any form.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

piezoelectric ultrasonic scaler (frequency of 28-36 KHz)

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

Gracey curettes

set of 7 instruments number #1-14

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Government College of Dentistry, Indore

OTHER

Sponsor Role: lead

Responsible Party

Dr DIVYA SINGH HADA

Post-graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Divya S. Hada, PG Student

Role: PRINCIPAL_INVESTIGATOR

Government College of Dentistry

References

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.

Reference Type: RESULT

PMID: 16644317 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22966824 (View on PubMed)

Other Identifiers

GCD-010/55/2013

Identifier Type: -

Identifier Source: org_study_id