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
Western Sydney Local Health District
60 participants
Jun 23, 2022
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
Inclusion Criteria4
- have coronary artery disease
- hsCRP >2mg/L
- have moderate-severe periodontitis
- are currently on statin therapy
Exclusion Criteria11
- Have received subgingival scaling and root planning in the last 6 months
- Are currently taking or have had antibiotic therapy in the last 3 months
- Are currently pregnant or planning pregnancy
- Are currently lactating/breastfeeding
- Have renal impairment
- Have hepatic impairment
- Have blood dyscrasias
- Are taking medications which interact with colchicine
- Have Type 1 Diabetes Mellitus
- Have moderate or severe periodontitis
- Have urgent and/or extensive dental therapy needs that will hinder periodontal treatment
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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 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)
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ACTRN12619001573145