CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 34 enrolled
Drug / intervention
Aspirin +3 moredrug
Likely dose
Omega-3 polyunsaturated fatty acids 3g daily plus aspirin 100mg daily over 180 daysAI-extracted
Key inclusion· 4
  • Diagnosis of generalized aggressive periodontitis per Armitage 1999 or AAP 2015 criteria
  • Prior full-mouth ultrasonic debridement completed (first-line periodontal treatment)
  • At least one residual probing depth ≥5 mm with bleeding on probe (not in furcation)
  • Good general health status
Key exclusion· 7
  • ASA Class III-V (serious systemic disease: cardiovascular alterations, blood dyscrasias, immunodeficiency)
  • Antibiotic or anti-inflammatory use in prior 6 months
  • Smoking ≥10 cigarettes per day
  • Pregnant or lactating women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093207
NCT03093207Phase 3Completed

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

Universidade Estadual Paulista Júlio de Mesquita Filho·interventional·Posted Mar 28, 2017·Updated Nov 17, 2020

In Brief

A Phase 3 clinical trial evaluating Open flap debridement, Placebo, and 2 other interventions for Residual Disease and Aggressive Periodontitis. Completed, enrolled 34 participants across 1 site.

Detailed 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 months after the procedure will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartMay 15, 2017
Primary CompletionOct 1, 2018
Study CompletionJun 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.3 years ago

Interventions

Open flap debridementprocedure

Open flap debridement will be performed to decontaminate root surface

Placeboother

Placebo pills over a period of 180 days

Omega-3 polyunsaturated fatty acidsdietary

3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days

Aspirindrug

100 mg of aspirin daily supplementation over a period of 180 days