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Trial registered on ANZCTR


Registration number
ACTRN12619000913178
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
28/06/2019
Date last updated
28/06/2019
Date data sharing statement initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Human lipidome analysis of healthy and disease gums before and after conventional treatments.
Scientific title
Lipidome analysis of gingival health, biofilm induced gingivitis, and stage III and IV periodontitis: A prospective clinical trial
Secondary ID [1] 296992 0
Nil known
Universal Trial Number (UTN)
U1111-1226-3673
Trial acronym
HLA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 310955 0
Gingivitis 310956 0
Gingival Health 310957 0
Condition category
Condition code
Oral and Gastrointestinal 309620 309620 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 309621 309621 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Visit 1 (Week 1):
Pre-Operative Periodontal Chart by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist)
- This provides allocation of participants into Gingival Health, Gingivitis and Periodontitis
- Charting is completed with the aid of an electronic probe (FLORIDAProbe TGA APPROVED) to provide information about how much bone is lost around the teeth and how inflamed the gingiva is.
- Saliva samples and Gingival Crevicular Fluid also collected at this point time.
ample Collection:
1. GCF samples will be collected from each patient at each time point using an established protocol (Barros, Williams et al. 2016), where paper points (PerioCol Paper Strips, #593530, Oraflow inc.) will be inserted into the deepest pocket per tooth with minimum of two teeth examined in each sextant.
2. Saliva samples will be collected from each patient as resting saliva using SialoPaper Strips (#593528, Oraflow inc.) at each time point.
3. GCF and saliva samples will be collected and immediately stored at minus 70 degrees till the assays are to be performed.
- Duration of 1 hour

Visit 2 (Week 4): (Depending on what category the participant falls in, either arm 1 or arm 2 the following occurs)
Arm 1: Supragingival Removal of Calculus and Dental Biofilm (Gingivitis Group)
- supragingival use of hand scalars and ultra sonic scalars by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist)
- all teeth treated for a duration of 30 minutes, single intervention
- Location is Metro North Oral Health Centre, Clinic 6.1 Specialist Suites
Arm 2: Non-surgical Periodontal Full Mouth Debridement (Periodontitis Group)
- supragingival and subgingival use of hand scalars and ultra sonic scalars by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist)
- all teeth treated for a duration of 2 hours, single intervention


Visit 3 (Week 10):
Participants will be recalled 9 weeks from the initial visit to re-assess periodontal parameters (full mouth chart) & saliva and GCF samples obtained. This will be compared to baseline measures and biomarkers will be mapped.
- Duration 60 minutes
Periodontal Disease patients placed into regular therapy as per the standard of care, involving routine non-surgical therapy and regular review of their gingival tissues.


All participants will have a total of 3 visits expected over a period of 10 weeks.


They key difference between the control group(healthy) and the disease groups is that there is no use of the ultra sonic hand scalar nor is there any subgingival instrumentation. The control group will utilise the prophylactic cup to remove plaque in a comfortable manner.


Upon review of the ANZCTR commentary it appears that due to the allocation of disease category this is not a randomised trial.
Intervention code [1] 313264 0
Prevention
Intervention code [2] 313265 0
Treatment: Other
Comparator / control treatment
The control treatment involves the following:
- Periodontal Gum Assessment and Charting (Using an electronic probe, the FLORIDAProbe the pockets around teeth are measured and recorded into a computer software)
- Saliva and Gingival Fluid Analysis (GCF)
Sample Collection:
1. GCF samples will be collected from each patient at each time point using an established protocol (Barros, Williams et al. 2016), where paper points (PerioCol Paper Strips, #593530, Oraflow inc.) will be inserted into the deepest pocket per tooth with minimum of two teeth examined in each sextant.
2. Saliva samples will be collected from each patient as resting saliva using SialoPaper Strips (#593528, Oraflow inc.) at each time point.
3. GCF and saliva samples will be collected and immediately stored at minus 70 degrees till the assays are to be performed.
These two steps above are the same as the intervention groups.
The third step below is how the treatment differs from the intervention group:
- Supragingival Removal of Calculus and Dental Biofilm using a high speed prophy hand piece and a sickle scalar by a registered dentist(Dr Akila Vithanage) who is training in Periodontics (Gum Specialist)
- all teeth treated for a duration of 30 minutes, single intervention
- Location is Metro North Oral Health Centre, Clinic 6.1 Specialist Suites.
No ultrasonic is used and no subgingival instrumentation is to occur.
Control group
Active

Outcomes
Primary outcome [1] 318593 0
Resolvin E1 level as assessed by saliva and gingival crevicular flow analysis
Timepoint [1] 318593 0
6 months from study commencement.
Primary outcome [2] 320583 0
Probing Depth as measured by the FLORIDAprobe
Timepoint [2] 320583 0
6 months from study commencement.
Secondary outcome [1] 365532 0
Composite outcome of pro-inflammatory lipid profiles measured by periodontal charting exam after non-surgical periodontal therapy. Components that will be assessed include prostaglandins E2 (PGE2), D2 (PGD2), F2a (PG F2a Glutathione peroxidase (GSHPx), and salivary malondialdehyde (MDA). These are measured during the periodontal chart and review chart appointment with the aid of the FLOIRDAProbe and saliva and GCF analysis.
Timepoint [1] 365532 0
6 months

Eligibility
Key inclusion criteria
Inclusion Criteria:
- Referred into the Periodontal Clinic for implant restoration or Periodontal Therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria & Adjustable Comorbidities:
- Smoking (this will be statistically adjusted and profiled according to the current periodontal grading criteria)
- Uncontrolled Diabetes (this will be statistically adjusted and profiled according to the current periodontal grading criteria)
- Controlled Diabetes will be deemed that of HbA1c of <6.5% (2018 ADA Definitions) at the time of data collection and will be considered the same as a non-diabetic.
- Age (this will be statistically adjusted and profiled according to the current periodontal grading criteria)
- Immunosuppressive Drugs (this will be statistically adjusted and profiled according to the current periodontal grading criteria)
- Anti-inflammatory Drugs & Supplements (this will be statistically adjusted and profiled according to the current periodontal grading criteria)
- Plaque control (this will be statistically adjusted and profiled according to the current periodontal grading criteria)

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)
nil applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be categorised by the following definitions:
- Periodontal health, less than 30% of sites Bleeding on Probing (BOP) and periodontal pocket depth (PPD) less than or equal to 3mm
- Gingivitis greater than 30% of sites BOP and PPD less than or equal to 3mm
- Periodontitis, greater than 10% of sites BOP and at least one site of PPD greater than or equal to 4mm.
Chapple et al. 2018
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Data Entry will be manual into Excel and then converted into R for statistical programming by the trained primary investigator.
Data Analysis Package – R Statistical Package
Outcome data and demographic data will be presented in the form of tables.
Choice of statistical test used is the Mann Whitney test, there is no assumption of normal distributions due to the varying degrees of periodontal disease, this will assess whether it is equally likely that a randomly selected value from one sample will be less than or greater than a randomly selected value from a second sample, as group variations it will compute lipidome variations and resolvin ratio variations. In the instance that data is normally distributed amongst the cohorts a student T test may be utilised.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12840 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25311 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 301562 0
University
Name [1] 301562 0
School of Dentistry and Oral Health - University of Queensland
Country [1] 301562 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Dentistry and Oral Health
288 Herston Road
Corner Bramston Tce and Herston Rd
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 301270 0
None
Name [1] 301270 0
Address [1] 301270 0
Country [1] 301270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302293 0
The Prince Charles Hospital Human Research Ethics Committee [EC00168]
Ethics committee address [1] 302293 0
Ethics committee country [1] 302293 0
Australia
Date submitted for ethics approval [1] 302293 0
27/03/2019
Approval date [1] 302293 0
13/06/2019
Ethics approval number [1] 302293 0
HREC/2019/QPCH/50790

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89726 0
Dr Akila Vithanage
Address 89726 0
DR AKILA VITHANAGE Doctor of Clinical Dent. Year 2 Student
University of Queensland
Metro North Oral Health Clinic
Room 6
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 89726 0
Australia
Phone 89726 0
+61466 592 791
Fax 89726 0
Email 89726 0
a.vithanage@uqconnect.edu.au
Contact person for public queries
Name 89727 0
Akila Vithanage
Address 89727 0
DR AKILA VITHANAGE Doctor of Clinical Dent. Year 2 Student
University of Queensland
Metro North Oral Health Clinic
Room 6
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 89727 0
Australia
Phone 89727 0
+61466 592 791
Fax 89727 0
Email 89727 0
a.vithanage@uqconnect.edu.au
Contact person for scientific queries
Name 89728 0
Akila Vithanage
Address 89728 0
DR AKILA VITHANAGE Doctor of Clinical Dent. Year 2 Student
University of Queensland
Metro North Oral Health Clinic
Room 6
6.1 Specialist Suites
Oral Health Centre, 288 Herston Road
Corner Bramston Terrace and Herston Road
Herston QLD 4006, Australia
Country 89728 0
Australia
Phone 89728 0
+61466 592 791
Fax 89728 0
Email 89728 0
a.vithanage@uqconnect.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
Due to ethical and confidentiality reasons this data will not be publicly available, if the data is published it will be de-identified of any patient identification.


What supporting documents are/will be available?

No Supporting Document Provided



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.