Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001307190
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
25/09/2019
Date last updated
25/09/2019
Date data sharing statement initially provided
25/09/2019
Date results information initially provided
25/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The bacteria associated with periodontal disease before and after treatment.
Scientific title
Microbiome profile of responding and non-responding periodontal pockets after non-surgical periodontal treatment: A longitudinal study.
Secondary ID [1] 299193 0
Nil known
Universal Trial Number (UTN)
U1111-1239-7198
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 314296 0
Condition category
Condition code
Infection 312651 312651 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 312652 312652 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 312786 312786 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
Non-surgical periodontal treatment including subgingival debridement (removal of subgingival plaque and calculus). This treatment is the currently recognised best practice treatment for periodontitis. This treatment involves scraping the teeth with hand scalers, the use of an ultrasonic scaler to remove calculus, polishing the teeth with a professional polishing paste, and oral hygiene instructions.
The treatment will be performed by a registered dentist in a specialist-in-training program. The treatment will be carried out over 4 x 2 hr appointments over a 4-6 week period. The treatment will be carried out in the Periodontics department of the Royal Melbourne Dental Hospital.
All interventions will be recorded in the patient file by the practicing clinician and checked off the patient's treatment plan.
Intervention code [1] 315492 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321300 0
Periodontal pocket depth. Periodontal pocket depth will be measured to the nearest millimeter manually using a graduated periodontal probe.
Timepoint [1] 321300 0
Three months after completion of non-surgical periodontal treatment.
Secondary outcome [1] 374562 0
Bleeding on probing. This will be recorded visually as either present or absent by the clinician immediately after recording the periodontal pocket depth.
Timepoint [1] 374562 0
3 months following completion of the non-surgical periodontal treatment, at the same appointment as the periodontal pocket depth is recorded.
Secondary outcome [2] 374886 0
Microbial community profile of subgingival plaque.
Timepoint [2] 374886 0
The subgingival plaque will be collected 3 months post non-surgical therapy. Laboratory analysis of these samples will take 8 - 12 weeks for results.

Eligibility
Key inclusion criteria
Patients with periodontitis as determined by the presence of at least 4 diseases single-rooted teeth defined by >/= 1 site a the tooth with a probing pocket depth of >/= 5 mm with bleeding on probing.
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of antibiotics in the prior 3 months, pregnancy or lactation, systemic conditions which may affect the progression of periodontitis (eg diabetes), any condition requiring premedication prior to treatment, long-term therapy with non-steroidal anti-inflammatory drugs and history of periodontal treatment within the past 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/05/2018
Date of last participant enrolment
Anticipated
Actual
12/10/2018
Date of last data collection
Anticipated
Actual
15/02/2019
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303734 0
Charities/Societies/Foundations
Name [1] 303734 0
Australian Periodontology Research Foundation
Country [1] 303734 0
Australia
Primary sponsor type
Individual
Name
Samantha Byrne
Address
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton 3035
Victoria
Country
Australia
Secondary sponsor category [1] 303850 0
Individual
Name [1] 303850 0
Ivan Darby
Address [1] 303850 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton 3035
Victoria
Country [1] 303850 0
Australia
Secondary sponsor category [2] 303856 0
Individual
Name [2] 303856 0
Stuart Dashper
Address [2] 303856 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton 3035
Victoria
Country [2] 303856 0
Australia
Other collaborator category [1] 280942 0
Other Collaborative groups
Name [1] 280942 0
Oral Health CRC
Address [1] 280942 0

Level 6, 720 Swanston Street
Calton Vic 3053
Country [1] 280942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304258 0
Medicine and Dentistry Human Ethics Sub-Committee, The University of Melbourne
Ethics committee address [1] 304258 0
Alan Gilbert Building
Level 5, The University of Melbourne
161 Barry Street
Parkville 3010
Victoria
Ethics committee country [1] 304258 0
Australia
Date submitted for ethics approval [1] 304258 0
Approval date [1] 304258 0
11/05/2018
Ethics approval number [1] 304258 0
1750598

Summary
Brief summary
The aim of this project is to determine if there is a difference in microbial community between responsive and non-responsive sites. A secondary aim is to determine if there is a difference in microbial community between responded and healthy sites.

The objective is to establish the microbial community profile associated with sites that respond poorly to periodontal treatment.
The specific hypothesis tested is whether certain subgingival microbial profiles are associated with poor response to periodontal treatment in a prospective longitudinal clinical study in a Melbourne population.

Achieving the above aim may assist with a better understanding of the polymicrobial aetiology of chronic periodontitis and its effect on treatment. The establishment of a microbial community profile associated with sites that respond poorly to periodontal treatment may allow for the pre-operative identification and allow more targeted treatment of these sites.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96314 0
Dr Samantha Byrne
Address 96314 0
Melbourne Dental School
720 Swanston Street
Carlton 3053
Victoria
Country 96314 0
Australia
Phone 96314 0
+61 3 93411541
Fax 96314 0
Email 96314 0
[email protected]
Contact person for public queries
Name 96315 0
Dr Samantha Byrne
Address 96315 0
Melbourne Dental School
720 Swanston Street
Carlton 3053
Victoria
Country 96315 0
Australia
Phone 96315 0
+61 3 93411541
Fax 96315 0
Email 96315 0
[email protected]
Contact person for scientific queries
Name 96316 0
Dr Samantha Byrne
Address 96316 0
Melbourne Dental School
720 Swanston Street
Carlton 3053
Victoria
Country 96316 0
Australia
Phone 96316 0
+61 3 93411541
Fax 96316 0
Email 96316 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?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
For IPD meta-analysis.
How or where can data be obtained?
IPD data will be available following contact with the Principal investigator via email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4576Study protocol  [email protected]
4577Clinical study report  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMicrobiome profiles of non-responding and responding paired periodontitis sites within the same participants following non-surgical treatment.2022https://dx.doi.org/10.1080/20002297.2022.2043595
N.B. These documents automatically identified may not have been verified by the study sponsor.