Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Phase: PHASE2
Conditions: Residual Disease, Aggressive Periodontitis
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

 
 
 
 
 
 
 
 
 
 
 
 
Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose 
Aspirin Daily Supplementation in Surgical Therapy to Treat Generalized 
Aggressive Periodontitis: Randomized Controlled Clinical Trial 
 
 
NCT03093207 
 
 
May 15, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
Periodontal destruction results mainly from the exacerbated host inflammatory 
response to the bacterial challenge. For this reason, research involving the 
modulation of host response has been developed aiming to facilitate the 
resolution of inflammation, as well as to promote tissue repair and periodontal 
stability. Recently, the use of omega-3 polyunsaturated fatty acids (Ω-3 PUFA) 
and low-dose acetylsalicylic acid (ASA) was related to the production of 
enhanced lipidic mediators and to better clinical outcomes in the treatment of 
chronic periodontitis. Thus, the aim of the present randomized controlled clinical 
trials was to evaluate the use of 900 mg Ω-3 PUFA and 100 mg ASA for 180 days 
as adjuvants to the treatment of generalized aggressive periodontitis (GAgP). 
Thirty-four GAgP patients previously submitted to NST with residual pockets were 
selected and underwent open flap debridement associated with Ω-3 PUFA 3 and 
ASA (n=17) or placebo (n=17). After 6 months, both therapies led to decreased 
PD (p>0.05), but only the test group had CAL gain in the intergroup comparison 
(p=0,02), as well as presented less gingival recession (p=0,03), decreased dentin 
hypersensitivity (p=0,01), lower consumption of analgesics (p=0,02) and 
significant intragroup reduction of IL-10 (p<0.05). The microbiological analysis of 
the residual pockets did not reveal significant changes compared to baseline. It 
was concluded that the proposed new therapy brought clinical benefits to the 
surgical treatment of GAgP patients. 
 
 
 
 
 
 
 
 
 
 
 
 

Statistical Analysis Plan 
 
Mean and standard deviation were calculated in each of the parameters. PI, BoP, 
PD, CAL, and GR were submitted to the Shapiro-Wilk test to evaluate the 
distribution of these data, and then subjected to the variance test for both intra- 
and intra-group comparison. In addition, the number of pockets ≥ 5mm, the 
frequency of closure of these pockets, the mean reduction in PS and the gain in 
CAL of these pockets were assessed before and after the therapy by performing 
intra- and inter-group analyzes. IBM SPSS software was used to data analyses. 
The concentration of each cytokine/microorganism were analyzed by test of 
variance for intra and intergroup comparison.