None listed
Conditions
Brief 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.
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 w
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.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- have coronary artery disease - hsCRP >2mg/L - have moderate-severe periodontitis - are currently on statin therapy
Exclusion criteria
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
Outcome results
None listed