Clinical Trial: Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Generalized Aggressive Periodontitis: Randomized

Brief Summary: The aim of this randomized controlled clinical trial of superiority will be to evaluate the effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily supplementation over a period of 180 days as adjunct to surgical therapy of residual pockets from patients with generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6 12 months after the procedure will be evaluated.

Detailed Summary:

The study is designed as a prospective, interventional, parallel, blinded, randomized, controlled clinical trial clinical of superiority, with a 1-year follow-up. The methodology of the present study will follow the standards of CONSORT-STATEMENT 2010 (Moher et al., 2010) and SPIRIT 2013 (Chan et al., 2013) for randomized clinical trials.

Source of data The population will be composed of patients diagnosed with generalized aggressive periodontitis (GAgP) recruited at Institute of Science and Technology - Unesp, in São José dos Campos / SP, who have already undergone non-surgical periodontal treatment and still have pockets with probing depth ≥5 mm and bleeding on probe.

Sample size For this study, a population of 34 patients will be included. Considering α = 5% and β = 5% (power of 95%) to detect a difference of at least 1 mm in probing depth reduction between groups, to a standard deviation of 0.8 mm of a previous study evaluating the effect of daily supplementation of omega-3 fatty acids and low-dose aspirin in the treatment of patients with chronic periodontitis (El-Sharkawy, 2010), 17 patients will be required in each group.

Clinical Parameters All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before surgical therapy (baseline) and at 3, 6 ans 12 months after using a manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars.

The following clinical parameters will be evaluated: 1) Full-mouth plaque index (PI); 2) Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket to gingival margin; 4) Gingiva
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Current Primary Outcome: Change in clinical attachment level [ Time Frame: Baseline, 3, 6 and 12 months ]

Evaluate the difference between baseline and 6 months CAL measures


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in probing depth [ Time Frame: Baseline, 3, 6 and 12 months ]
    Evaluate the difference between baseline and 6 months PB measures
  • Change in bleeding on probe [ Time Frame: Baseline, 3, 6 and 12 months ]
    Evaluate the difference between baseline and 6 months BoP measures


Original Secondary Outcome: Same as current

Information By: Universidade Estadual Paulista Júlio de Mesquita Filho

Dates:
Date Received: March 22, 2017
Date Started: May 15, 2017
Date Completion: September 2018
Last Updated: May 15, 2017
Last Verified: May 2017