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Trial registered on ANZCTR


Registration number
ACTRN12610000594022
Ethics application status
Approved
Date submitted
7/07/2010
Date registered
23/07/2010
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil as adjunct therapy for periodontitis.
Scientific title
Clinical efficacy of fish oil as adjunct therapy for patients with chronic periodontitis
Secondary ID [1] 251736 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 257345 0
Condition category
Condition code
Oral and Gastrointestinal 257488 257488 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 257489 257489 0 0
Other inflammatory or immune system disorders
Public Health 257490 257490 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-blind, randomized, placebo-controlled intervention trial will be conducted in 126 patients with newly diagnosed severe but non aggressive periodontitis by a collaborating team from the Colgate Australian Clinical Dental Research Centre (CACDRC), University of Adelaide and the Nutritional Physiology Research Centre, University of South Australia.
Prior to the initial periodontal treatment, a blood sample will be collected from the antecubital vein and gingival crevicular fluid (GCF) will be collected from two distinct sites of infection.
A full periodontal exam will be conducted to determine the extent of clinical attachment and pocket depth. Patients will then undergo treatment using mechanical debridement of plaque and calculus once a week for 4 consecutive weeks.
Prior to the initial treatment, patients will be allocated to one of three treatment groups to consume supplementation daily for 13 months as follows:-

1. Fish oil rich in the long chain omega-3 fatty acid eicosapentaenoic acid (EPA).
2. Fish oil rich in long chain omega-3 fatty acid docosahexaenoic acid (DHA)
3. Soya oil (placebo)

Each treatment group will orally consume 6 x 500mg capsules per day. DHA rich capsules contain 258mg DHA and 66mg EPA , EPA rich capsules contain 27mg DHA and 277mg EPA. Placebo capsules contain soya oil.

Once the inital 1 month of treatment is completed, patients will have repeat single periodontal exams (including scaling and cleaning) conducted every 3 months for 1 year, during which GCF samples will be collected to evaluate local inflammation. Participants will be instructed not to brush or floss their teeth, not to eat, and not to drink anything but plain water within a period of 4 hours prior to crevicular fluid sampling.
Fasting blood samples (10ml) will be collected after 3 and 12 months. At each visit information will also be collected to monitor general health and use of medication
Intervention code [1] 256760 0
Treatment: Other
Comparator / control treatment
soya oil (6 x 500mg capsules per day consumed orally)
Control group
Placebo

Outcomes
Primary outcome [1] 258407 0
Probing pocket depth:
This will be measured from the gingival margin to the base of the periodontal pocket using a constant force automated periodontal probe (FP32, Florida Probe Corporation, Gainesville, FL, USA).
Timepoint [1] 258407 0
Baseline (0mths), 4mths, 7mths, 10mths, 13 months.
Primary outcome [2] 258740 0
Clinical attachment level (CAL):
This will be measured from the cemento-enamel junction or another fixed reference such as a crown margin to the base of the periodontal pocket with a dental probe.
Timepoint [2] 258740 0
Baseline (0mths), 4mths, 7mths, 10mths, 13 mths
Secondary outcome [1] 264158 0
inflammatory biomarkers in gingival crevicular fluid
Timepoint [1] 264158 0
Baseline (0mths), 4mths, 7mths, 10mths, 13 mths
Secondary outcome [2] 264159 0
Biomarker of Omega-3 incorporation and bioavailability:-
Omega-3 fatty acids will be assessed by gas chromatography in erythrocytes isolated from venous blood samples.
Timepoint [2] 264159 0
Baseline (0mths), 4mths, 13mths.
Secondary outcome [3] 264160 0
Serum C-reactive protein will be assessed
Timepoint [3] 264160 0
Baseline (0mths), 4mths, 13mths.

Eligibility
Key inclusion criteria
1) Advanced chronic periodontitis in accordance with the definition established by the Centre for Disease Control and Prevention and American Academy of Periodontology (Page and Eke, 2007). As such patients will have two or more interproximal sites with attachment loss greater than or equal to 6mm, not on the same tooth, and one or more interproximal sites with probing depths greater than or equal to 5mm, not on the same tooth.

2) Non-smoker
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol
2) Smokers and ex-smokers within the last 2 years
3) Fish oil consumption >1g/d or recently modified ie. within the last 3 months
4) Therapy for periodontitis in the past 6 months
5) Antibiotic therapy within the past 3 months
6) Anticoagulant therapy, anti-platelet agents
7) Taking other anti-platelet agents; bleeding disorders
8) Gastrointestinal disease, including peptic ulcers
9) Participation in another study within 30 days of commencement of the present study
10) Pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects meeting entry criteria at screening will be allocated to a treatment at random by the study code-holder who will remain blinded to their identities.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
ID numbers will be randomly allocated to treatment in blocks and there will be a rolling recruitment of participants. Doses will be allocated a letter A-C for identification and will not be decoded until all the data has been analysed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
26/07/2010
Actual
26/07/2010
Date of last participant enrolment
Anticipated
Actual
9/06/2017
Date of last data collection
Anticipated
Actual
9/07/2018
Sample size
Target
126
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3026 0
5001
Recruitment postcode(s) [2] 3027 0
5000

Funding & Sponsors
Funding source category [1] 256951 0
University
Name [1] 256951 0
University of South Australia
Country [1] 256951 0
Australia
Funding source category [2] 257257 0
University
Name [2] 257257 0
University of Adelaide
Country [2] 257257 0
Australia
Primary sponsor type
Individual
Name
Prof Mark Bartold
Address
Colgate Australian Clinical Dental Research Centre
University of Adelaide
Department of Dentistry
Frome Road
Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 256498 0
Individual
Name [1] 256498 0
Prof Peter Howe
Address [1] 256498 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country [1] 256498 0
Australia
Secondary sponsor category [2] 256499 0
Individual
Name [2] 256499 0
Dr Alison Coates
Address [2] 256499 0
Nutritional Physiology Reserach Centre
University of South Australia
GPO Box 2471,
Adelaide, South Australia 5001
Country [2] 256499 0
Australia
Secondary sponsor category [3] 256500 0
Individual
Name [3] 256500 0
Dr Toby Hughes
Address [3] 256500 0
Colgate Australian Clinical Dental Research Centre
University of Adelaide
Department of Dentistry
Frome Road
Adelaide, South Australia 5005
Country [3] 256500 0
Australia
Other collaborator category [1] 251369 0
Individual
Name [1] 251369 0
Prof Thomas van Dyke
Address [1] 251369 0
Clinical Research Centre
School of Dental Medicine
Boston University
100 East Newton Street room G-107
Boston, MA 02118
Country [1] 251369 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258951 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 258951 0
Ethics committee country [1] 258951 0
Australia
Date submitted for ethics approval [1] 258951 0
30/03/2010
Approval date [1] 258951 0
03/06/2010
Ethics approval number [1] 258951 0
H-037-2010
Ethics committee name [2] 259273 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 259273 0
Ethics committee country [2] 259273 0
Australia
Date submitted for ethics approval [2] 259273 0
03/06/2010
Approval date [2] 259273 0
09/06/2010
Ethics approval number [2] 259273 0
H-037-2010

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

Contacts
Principal investigator
Name 31149 0
Address 31149 0
Country 31149 0
Phone 31149 0
Fax 31149 0
Email 31149 0
Contact person for public queries
Name 14396 0
Prof Mark Bartold
Address 14396 0
The University of Adelaide
School of Dentistry
Frome Rd, Adelaide, SA 5005
Country 14396 0
Australia
Phone 14396 0
+61 8 8303 3435
Fax 14396 0
+61 8 8303 6429
Email 14396 0
mark.bartold@adelaide.edu.au
Contact person for scientific queries
Name 5324 0
Dr Alison Coates
Address 5324 0
Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001
Country 5324 0
Australia
Phone 5324 0
+61 8 8302 2313
Fax 5324 0
+61 8 8302 2178
Email 5324 0
alison.coates@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.