Coronary Heart DiseaseNCT02417376

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

A study testing piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and Gracey curettes in people with Coronary Heart Disease and Periodontitis, run by Government College of Dentistry, Indore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Coronary Heart Disease, Periodontitis
What is being tested?: piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and Gracey curettes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: May 2013to Oct 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial

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.

Read the 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
Being tested: piezoelectric ultrasonic scaler (frequency of 28-36 KHz), Gracey curettes
Keywords: Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure
Medical subject headings: Coronary Disease, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Gracey curettesDevice
set of 7 instruments number #1-14

Study groups in NCT02417376
Study group	Role	What they receive
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 Receives: Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz); Device: Gracey curettes
Control	No intervention	No periodontal intervention in any form.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 6 months

Secondary outcomes (19)

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.
Measured: Baseline and 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.
Measured: Baseline and 3 months
Change From Baseline in Lipid Profile at 1 Month
Change from baseline in lipid profile assessed at 1 month.
Measured: Baseline and 1 month
Change From Baseline in Lipid Profile at 3 Months
Change from baseline in lipid profile assessed at 3 months.
Measured: Baseline and 3 months
Change From Baseline in Lipid Profile at 6 Months.
Change from baseline in lipid profile assessed at 6 months.
Measured: Baseline and 6 months
Change From Baseline WBC Profile at 1 Month
Change from baseline in white blood cell profile assessed at 1 month.
Measured: Baseline and 1 month
Change From Baseline WBC Profile at 3 Months
Change from baseline in white blood cell profile assessed at 3 months.
Measured: Baseline and 3 months
Change From Baseline WBC Profile at 6 Months
Change from baseline in white blood cell profile assessed at 6 months.
Measured: Baseline and 6 months
Systolic Blood Pressure at 1 Month
Systolic blood pressure at 1 month.
Measured: 1 month
Systolic Blood Pressure at 3 Months
Systolic blood pressure at 3 months.
Measured: 3 months
Systolic Blood Pressure at 6 Months
Systolic blood pressure at 6 months.
Measured: 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.
Measured: Baseline and 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.
Measured: Baseline and 6 months
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.
Measured: Baseline and 6 months
Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months
Change from baseline in periodontal parameter- bleeding on probing at 6 months.
Measured: Baseline and 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.
Measured: Baseline and 6 months
Diastolic Blood Pressure at 1 Month
Diastolic blood pressure at 1 month.
Measured: 1 month
Diastolic Blood Pressure at 3 Months
Diastolic blood pressure at 3 months.
Measured: 3 months
Diastolic Blood Pressure at 6 Months
Diastolic blood pressure at 6 months.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Oct 2014

First posted15 Apr 2015 (estimated)
Study startMay 2013
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02417376
Sponsor's protocol ID: GCD-010/55/2013
Status last verified: Jan 2017
First submitted: 4 Apr 2015
Last updated: 24 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 16644317
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.
PubMed 22966824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Nonsurgical Periodontal Treatment on Systemic Risk Markers of Cardiovascular Disease Clinically and Biochemically: A Randomized Trial
ClinicalTrials.gov ID: NCT02417376
Acronym / sponsor ID: GCD-010/55/2013
Conditions: Coronary Heart Disease, Periodontitis
Keywords: Coronary heart disease, Periodontitis, C-reactive protein, Blood pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Government College of Dentistry, IndoreUniversity, hospital or other
Study start: May 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 15 Apr 2015 (estimated)
Results: Posted 24 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Active comparator	Device: piezoelectric ultrasonic scaler (frequency of 28-36 KHz), Device: Gracey curettesPeriodontal 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
Control	No intervention	–No periodontal intervention in any form.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Experimental
Gracey curettesset of 7 instruments number #1-14	Device	Experimental

Primary outcome

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

19 secondary outcomes

Change From Baseline in C-Reactive Protein Level at 1 Month
Time frame: Baseline and 1 month
Change From Baseline in C-Reactive Protein Level at 3 Month
Time frame: Baseline and 3 months
Change From Baseline in Lipid Profile at 1 Month
Time frame: Baseline and 1 month
Change From Baseline in Lipid Profile at 3 Months
Time frame: Baseline and 3 months
Change From Baseline in Lipid Profile at 6 Months.
Time frame: Baseline and 6 months
Change From Baseline WBC Profile at 1 Month
Time frame: Baseline and 1 month
Change From Baseline WBC Profile at 3 Months
Time frame: Baseline and 3 months
Change From Baseline WBC Profile at 6 Months
Time frame: Baseline and 6 months
Systolic Blood Pressure at 1 Month
Time frame: 1 month
Systolic Blood Pressure at 3 Months
Time frame: 3 months
Systolic Blood Pressure at 6 Months
Time frame: 6 months
Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months
Time frame: Baseline and 6 months
Change From Baseline Periodontal Parameter- Gingival Index at 6 Months
Time frame: Baseline and 6 months
Change From Baseline Periodontal Parameter- Plaque Index at 6 Months
Time frame: Baseline and 6 months
Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months
Time frame: Baseline and 6 months
Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months
Time frame: Baseline and 6 months
Diastolic Blood Pressure at 1 Month
Time frame: 1 month
Diastolic Blood Pressure at 3 Months
Time frame: 3 months
Diastolic Blood Pressure at 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 24 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	35	30
Control	35	25

Primary outcome: Change From Baseline in C-Reactive Protein Level at 6 Months

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: mg/L

Measure	Experimental n = 35	Control n = 35
Value	6.30 (7.53)	4.94 (2.04)

Population analysed: All patients suffered from CHD and Periodontitis both.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	0 of 0	0 of 0	Not reported
Control	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16644317D'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 publication: PubMed 22966824Bokhari 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Divya S. Hada, PG Student principal investigator

Government College of Dentistry

Questions about this trial

What is this clinical trial studying?

A study testing piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and Gracey curettes in people with Coronary Heart Disease and Periodontitis, run by Government College of Dentistry, Indore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in C-Reactive Protein Level at 6 Months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02417376, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.