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

NCT02417376 | Completed Results

• 1 other identifier: GCD-010/55/2013
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease; Periodontitis

Keywords

Coronary heart disease; Periodontitis; C-reactive protein; Blood pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (19)

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

  Baseline and 1 month

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

  Baseline and 3 months

• Change From Baseline in Lipid Profile at 1 Month

  Baseline and 1 month

• Change From Baseline in Lipid Profile at 3 Months

  Baseline and 3 months

• Change From Baseline in Lipid Profile at 6 Months.

  Baseline and 6 months

Study Arms (2)

Experimental

ACTIVE COMPARATOR

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

Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz); Device: Gracey curettes

Control

NO INTERVENTION

No periodontal intervention in any form.

Interventions

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.

Experimental

Gracey curettes DEVICE

set of 7 instruments number #1-14

Experimental

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government College of Dentistry, Indore: lead

Related Publications (2)

• 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.

  PMID: 16644317 RESULT

• 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.

  PMID: 22966824 RESULT

MeSH Terms

Conditions

Coronary Disease; Periodontitis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

populations were taken only from a single center, the dropout, strict inclusion criteria, total number of patients to be included in the study was limited, influence of medical drug management of CHD not taken into consideration.

Results Point of Contact

• Title: Dr Divya Singh Hada
• Organization: GCD Indore

dr_dshada@yahoo.com

+918720898289

Study Officials

• Divya S. Hada, PG Student

  Government College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate Student

Study Record Dates

• First Submitted: April 4, 2015
• First Posted: April 15, 2015
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 24, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share