None listed
Conditions
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.
Interventions
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
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
Sponsors
Prof Mark Bartold
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
25 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed