CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
Aspirin +3 moredrug
Likely dose
Omega-3 polyunsaturated fatty acids 3 g daily and aspirin 100 mg daily for 180 daysAI-extracted
Key inclusion· 5
  • Diagnosis of generalized aggressive periodontitis (GAgP) per AAP 1999 classification
  • At least 20 teeth present
  • At least 6 sites with probing depth ≥5mm and bleeding on probing, plus ≥2 sites with probing depth ≥7mm (including incisors and first molars plus two other non-contiguous teeth)
  • Good general health
Key exclusion· 6
  • Pregnancy or lactating
  • Systemic disease (cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) that could alter periodontal disease course
  • Antimicrobial use within the previous 6 months
  • Current long-term anti-inflammatory drug use

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

Search/NCT03093246
NCT03093246Phase 3Completed

Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial

Universidade Estadual Paulista Júlio de Mesquita Filho·interventional·Posted Mar 28, 2017·Updated Dec 28, 2021

In Brief

A Phase 3 clinical trial evaluating Omega-3 polyunsaturated fatty acids, Aspirin, and 2 other interventions for Aggressive Periodontitis. Completed, enrolled 38 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 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.

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 CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.3 years ago

Interventions

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

Placeboother

Placebo pills over a period of 180 days

Full-mouth ultrasonic debridementprocedure

Full-mouth ultrasonic debridement will be performed in order to treat diseased sites