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Trial registered on ANZCTR


Registration number
ACTRN12619001573145
Ethics application status
Approved
Date submitted
11/11/2019
Date registered
14/11/2019
Date last updated
13/10/2022
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
Targeting 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)
U1111-1267-9602
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 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.
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
Secondary outcome [2] 407021 0
Periodontal parameters (Probing pocket depth, clinical attachment loss, bleeding on probing) as measured by clinical assessment.
Timepoint [2] 407021 0
Baseline and 8 weeks after intervention
Secondary outcome [3] 407022 0
Feasibility measure: Recruitment conversion rate.
This data will be collected from the study records - a screening log will be maintained for this purpose.
Timepoint [3] 407022 0
Baseline
Secondary outcome [4] 407023 0
Feasibility measure: Completion rate. This data will be collected from the study records - a treatment log will be maintained for this purpose.
Timepoint [4] 407023 0
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
Sex
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 moderate or severe periodontitis
• 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
23/06/2022
Date of last participant enrolment
Anticipated
23/06/2023
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
60
Accrual to date
5
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
Country [1] 304187 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145.
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
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
25/11/2019
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
[email protected]
Contact person for public queries
Name 97751 0
Dr Shalinie King
Address 97751 0
C24 Westmead Centre for Oral Health, Darcy Road, Westmead, NSW 2145
Country 97751 0
Australia
Phone 97751 0
+61 402166671
Fax 97751 0
Email 97751 0
[email protected]
Contact person for scientific queries
Name 97752 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be made available. Other documents that will be available include the study protocol and statistical analysis plan.
When will data be available (start and end dates)?
The data will be available beginning 9 months and ending 5 years after article publication.
Available to whom?
To researchers who provide a methodologically sound proposal to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims stated in the approved proposal.
How or where can data be obtained?
Proposals should be directed to the lead researcher ([email protected]). To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at the University Research Data Storage. (\\shared.sydney.edu.au\research-data\PRJ-PDCD_Pilot_)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17352Study protocol  [email protected]
17353Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.