Clinical Trial: Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-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 Non-surgical Therapy to Treat Generalized Aggressive Periodontitis: Random

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 non-surgical therapY of 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 methodology is according to CONSORT-STATEMENT 2010 for randomized controlled clinical trials.

Study Design The study is designed as a prospective, interventional, parallel, blinded, randomized, controlled clinical trial of superiority.

Source of data The population of this study will be recruited among patients referred to the Science and Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, a population of 38 patients will be included. Considering α of 5% and 10% β-type error (90% power) to detect a difference of at least 1 mm in probing depth reduction of pockets ≥ 5 mm between groups, for a standard deviation of 0.94 from a previous study evaluating different antimicrobials in the treatment of GAgP (Xajigeorgiou et al., 2006), 19 patients will be needed in each group.

Clinical Parameters All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 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 (FMPI); 2) Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of sulcus/pocket
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Current Primary Outcome: Change in probing depth [ Time Frame: Baseline, 3 and 6 months ]

Evaluate the difference between baseline and 6 months PB measures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in clinical attachment level [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months CAL measures.
  • Change in bleeding on probe [ Time Frame: Baseline, 3 and 6 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