Fish oil as adjunct therapy for periodontitis.

Not Applicable

• Conditions: Periodontitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Inflammatory and Immune System - Other inflammatory or immune system disorders; Public Health - Health promotion/education

• Registration Number: ACTRN12610000594022
• Lead Sponsor: Prof Mark Bartold

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-23
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probing pocket depth:<br>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).[Baseline (0mths), 4mths, 7mths, 10mths, 13 months.];Clinical attachment level (CAL):<br>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.[Baseline (0mths), 4mths, 7mths, 10mths, 13 mths]

Secondary Outcome Measures

Name	Time	Method
inflammatory biomarkers in gingival crevicular fluid[Baseline (0mths), 4mths, 7mths, 10mths, 13 mths];Biomarker of Omega-3 incorporation and bioavailability:-<br>Omega-3 fatty acids will be assessed by gas chromatography in erythrocytes isolated from venous blood samples.[Baseline (0mths), 4mths, 13mths.];Serum C-reactive protein will be assessed[Baseline (0mths), 4mths, 13mths.]