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Trial registered on ANZCTR


Registration number
ACTRN12619001573145p
Ethics application status
Submitted, not yet approved
Date submitted
11/11/2019
Date registered
14/11/2019
Date last updated
14/11/2019
Date data sharing statement initially provided
14/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of gum disease to reduce cardiovascular risk
Scientific title
Reducing the systemic inflammation associated with periodontitis to reduce risk in patients with coronary artery disease and on statin therapy- a randomized feasibility study
Secondary ID [1] 299713 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 315061 0
Periodontitis 315062 0
Condition category
Condition code
Cardiovascular 313395 313395 0 0
Coronary heart disease
Oral and Gastrointestinal 313396 313396 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 dentist 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.
Intervention code [1] 315979 0
Prevention
Intervention code [2] 315980 0
Treatment: Drugs
Intervention code [3] 315981 0
Treatment: Other
Comparator / control treatment
Participants in the control arm (Arm 4) and participants in Arm 2 will be provided with periodontal treatment after the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 321879 0
high-sensitivity C-reactive protein (hsCRP) measured via blood sample assessment
Timepoint [1] 321879 0
Baseline and 8 weeks after intervention
Secondary outcome [1] 376569 0
Full lipid profile measured via blood sample assessment
Timepoint [1] 376569 0
Baseline and 8 weeks after intervention

Eligibility
Key inclusion criteria
- have coronary artery disease
- hsCRP >2mg/L
- have moderate-severe periodontitis
- are currently on statin therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 a PSR index of code 4 in all six sextants
• Have urgent and/or extensive dental therapy needs that will hinder periodontal treatment


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A power calculation was done using a study by Sun et al. (Sun, Chen, Zhang, Ren, & Qin, 2010) which showed that with a sample size of 15 participants per arm, it is possible to detect a difference of 0.73mg/L hsCRP between intervention and control arms with a beta error of 90%.

All the analyses will be performed via Statistical Package for Social Sciences (SPSS version 23 Inc., Chicago, IL, USA) software. Numeric data will be described using mean and standard deviation. Qualitative data will be described in the form of frequencies and percentages. ANOVA test will be used for group comparison in quantities variables and Chi-square in qualitative variables. Inter-group differences will be analyzed by Chi-Square Test. The level of statistical significance was set at p-value<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15101 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 28397 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 304187 0
University
Name [1] 304187 0
The University of Sydney
Address [1] 304187 0
Camperdown, NSW 2006
Country [1] 304187 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 304418 0
None
Name [1] 304418 0
Address [1] 304418 0
Country [1] 304418 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304658 0
Western Sydney Local Health Department Human Research Ethics Committee
Ethics committee address [1] 304658 0
WSLHD Research Office, Research and Education Network, Darcy Rd, Westmead NSW 2145
Ethics committee country [1] 304658 0
Australia
Date submitted for ethics approval [1] 304658 0
04/11/2019
Approval date [1] 304658 0
Ethics approval number [1] 304658 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97750 0
Dr Rahena Akhter
Address 97750 0
C24 Westmead Centre for Oral Health, Darcy Road, Westmead, NSW 2145
Country 97750 0
Australia
Phone 97750 0
+61299804348
Fax 97750 0
Email 97750 0
rahena.akhter@sydney.edu.au
Contact person for public queries
Name 97751 0
Dr Rahena Akhter
Address 97751 0
C24 Westmead Centre for Oral Health, Darcy Road, Westmead, NSW 2145
Country 97751 0
Australia
Phone 97751 0
+61299804348
Fax 97751 0
Email 97751 0
rahena.akhter@sydney.edu.au
Contact person for scientific queries
Name 97752 0
Prof Joerg Eberhard
Address 97752 0
Charles Perkins Centre, The University of Sydney, Camperdown, NSW 2006
Country 97752 0
Australia
Phone 97752 0
+61 437 487 452
Fax 97752 0
Email 97752 0
joerg.eberhard@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently undecided
What supporting documents are/will be available?
No other documents available
Summary results
No Results