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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
Date results information initially provided
5/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Fish oil as adjunct therapy for periodontitis.
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Scientific title
Clinical efficacy of fish oil as adjunct therapy for patients with chronic periodontitis
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Secondary ID [1]
251736
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Periodontitis
257345
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Condition category
Condition code
Oral and Gastrointestinal
257488
257488
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
257489
257489
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0
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Other inflammatory or immune system disorders
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Public Health
257490
257490
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
256760
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Treatment: Other
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Comparator / control treatment
soya oil (6 x 500mg capsules per day consumed orally)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
258407
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Timepoint [1]
258407
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Baseline (0mths), 4mths, 7mths, 10mths, 13 months.
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Primary outcome [2]
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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.
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Assessment method [2]
258740
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Timepoint [2]
258740
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Baseline (0mths), 4mths, 7mths, 10mths, 13 mths
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Secondary outcome [1]
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inflammatory biomarkers in gingival crevicular fluid
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Assessment method [1]
264158
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Timepoint [1]
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Baseline (0mths), 4mths, 7mths, 10mths, 13 mths
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Secondary outcome [2]
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Biomarker of Omega-3 incorporation and bioavailability:-
Omega-3 fatty acids will be assessed by gas chromatography in erythrocytes isolated from venous blood samples.
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Assessment method [2]
264159
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Timepoint [2]
264159
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Baseline (0mths), 4mths, 13mths.
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Secondary outcome [3]
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Serum C-reactive protein will be assessed
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Assessment method [3]
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Timepoint [3]
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Baseline (0mths), 4mths, 13mths.
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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
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Minimum age
25
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
26/07/2010
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Actual
26/07/2010
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Date of last participant enrolment
Anticipated
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Actual
9/06/2017
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Date of last data collection
Anticipated
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Actual
9/07/2018
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Sample size
Target
126
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
3026
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5001
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Recruitment postcode(s) [2]
3027
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5000
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Funding & Sponsors
Funding source category [1]
256951
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University
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Name [1]
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University of South Australia
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Address [1]
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Nutritional Physiology Research Centre
GPO Box 2471, Adelaide SA 5001
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Country [1]
256951
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Australia
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Funding source category [2]
257257
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University
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Name [2]
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University of Adelaide
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Address [2]
257257
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Colgate Australian Clinical Dental Research Centre
University of Adelaide
Department of Dentistry
Frome Road
Adelaide, South Australia 5005
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Country [2]
257257
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Australia
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Primary sponsor type
Individual
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Name
Prof Mark Bartold
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Address
Colgate Australian Clinical Dental Research Centre
University of Adelaide
Department of Dentistry
Frome Road
Adelaide, South Australia 5005
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Country
Australia
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Secondary sponsor category [1]
256498
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Individual
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Name [1]
256498
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Prof Peter Howe
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Address [1]
256498
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Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
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Country [1]
256498
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Australia
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Secondary sponsor category [2]
256499
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Individual
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Name [2]
256499
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Dr Alison Coates
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Address [2]
256499
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Nutritional Physiology Reserach Centre
University of South Australia
GPO Box 2471,
Adelaide, South Australia 5001
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Country [2]
256499
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Australia
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Secondary sponsor category [3]
256500
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Individual
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Name [3]
256500
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Dr Toby Hughes
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Address [3]
256500
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Colgate Australian Clinical Dental Research Centre
University of Adelaide
Department of Dentistry
Frome Road
Adelaide, South Australia 5005
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Country [3]
256500
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Australia
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Other collaborator category [1]
251369
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Individual
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Name [1]
251369
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Prof Thomas van Dyke
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Address [1]
251369
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Clinical Research Centre
School of Dental Medicine
Boston University
100 East Newton Street room G-107
Boston, MA 02118
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Country [1]
251369
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
258951
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University of Adelaide Human Research Ethics Committee
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Ethics committee address [1]
258951
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Research Ethics and Compliance Unit Research Branch, Level 7, 115 Grenfell St The University of Adelaide South Australia AUSTRALIA 5005
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Ethics committee country [1]
258951
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Australia
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Date submitted for ethics approval [1]
258951
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30/03/2010
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Approval date [1]
258951
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03/06/2010
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Ethics approval number [1]
258951
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H-037-2010
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Ethics committee name [2]
259273
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University of South Australia Human Research Ethics Committee
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Ethics committee address [2]
259273
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PO Box 2471
Adelaide SA 5001
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Ethics committee country [2]
259273
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Australia
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Date submitted for ethics approval [2]
259273
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03/06/2010
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Approval date [2]
259273
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09/06/2010
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Ethics approval number [2]
259273
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H-037-2010
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Summary
Brief summary
Periodontitis is a chronic inflammatory condition affecting 1 in 5 Australian adults. Current treatment involves intensive cleaning although treatment does not completely resolve the associated inflammation. The long chain omega-3 polyunsaturated fatty acids (omega-3) from fish oil help reduce inflammation in several chronic conditions.
Regular consumption of food rich in omega-3 may benefit periodontal health. Studies suggest that omega-3 metabolites may serve as “stop signals” for preventing neutrophil-mediated tissue damage, a key component of periodontal disease. Studies in rodents show a positive, modulating effect of omega-3 on gingival inflammation, which can be mediated through reduced expression of pro-inflammatory cytokines. Other reports that are less positive have used limited treatment periods which may have been insufficient to induce substantial incorporation of omega-3 into cell membranes.
The aim of this study is to see whether supplementation with different types of fish oil improves the efficacy of standard periodontal treatment (scaling and debridement) in patients with newly diagnosed, but not aggressive periodontitis. We will also investigate the involvement of anti-inflammatory mechanisms.
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Trial website
not applicable
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Trial related presentations / publications
not applicable
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Public notes
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Contacts
Principal investigator
Name
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Address
31149
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Country
31149
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Phone
31149
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Fax
31149
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Email
31149
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Contact person for public queries
Name
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Prof Mark Bartold
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Address
14396
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The University of Adelaide
School of Dentistry
Frome Rd, Adelaide, SA 5005
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Country
14396
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Australia
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Phone
14396
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+61 8 8303 3435
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Fax
14396
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+61 8 8303 6429
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Email
14396
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[email protected]
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Contact person for scientific queries
Name
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Dr Alison Coates
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Address
5324
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Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide,
South Australia, 5001
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Country
5324
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Australia
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Phone
5324
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+61 8 8302 2313
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Fax
5324
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+61 8 8302 2178
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Email
5324
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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