RecruitingPhase 1ACTRN12619001573145

Treatment of gum disease to reduce cardiovascular risk

Targeting the systemic inflammation associated with periodontitis to reduce risk in patients with coronary artery disease and on statin therapy- a randomized feasibility study


Sponsor

Western Sydney Local Health District

Enrollment

60 participants

Start Date

Jun 23, 2022

Study Type

Interventional

Conditions

Summary

Health professionals have long established a link between gum disease and cardiovascular disease. However, whether the treatment of gum disease reduces the risk of having a cardiovascular incident, for example- a heart attack, remains a question mark. Colchicine is a drug that has been shown to reduce cardiovascular risk. This trial aims to help ascertain whether a combination of gum disease therapy and colchicine therapy will reduce the risk of having a cardiovascular incident.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

There is a well-established link between gum disease (periodontitis) and heart disease — people with moderate to severe gum disease have a higher risk of heart attacks and other cardiovascular events. Gum disease causes inflammation throughout the body, and inflammation is one of the key drivers of cardiovascular disease. Treating gum disease might therefore help reduce heart disease risk. This trial is combining two approaches to reducing cardiovascular risk: professional gum disease treatment (deep cleaning of the teeth and gums) and a low-dose anti-inflammatory medication called colchicine, which has been shown to reduce heart attack risk in people with existing heart disease. The study aims to find out whether this combined approach lowers markers of inflammation in the blood and reduces the overall risk of a cardiovascular event. You may be eligible if you have been diagnosed with coronary artery disease, are currently taking a statin medication, have elevated inflammation markers in your blood (hsCRP >2 mg/L), and have been diagnosed with moderate to severe periodontitis (gum disease). People who have had recent gum treatment, are pregnant or breastfeeding, or have kidney or liver impairment would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be allocated to one of four arms: 1) Periodontal treatment 2) Colchicine administration 3) Periodontal treatment + colchicine administration 4) No treatment Periodontal trea

Participants will be allocated to one of four arms: 1) Periodontal treatment 2) Colchicine administration 3) Periodontal treatment + colchicine administration 4) No treatment Periodontal treatment will involve scaling and root planing following the American Academy of Periodontology treatment guidelines. This will be performed over 3 separate appointments, beginning at baseline with a 1-2 week interval between appointments. Each appointment will be 30-60 minutes in duration and the treatment will be carried out by a registered oral health practitioner at the Westmead Centre for Oral Health. Colchicine will be administered via 0.5mg tablets to be taken by the participants once daily for 8 weeks. Participants will be asked to return unused tablets to ascertain adherence to the Colchicine.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12619001573145


Related Trials