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

NCT03093207 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-11-17

Study results available
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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.

Conditions

  • Residual Disease
  • Aggressive Periodontitis

Interventions

PROCEDURE

Open flap debridement

Open flap debridement will be performed to decontaminate root surface

OTHER

Placebo

Placebo pills over a period of 180 days

DIETARY_SUPPLEMENT

Omega-3 polyunsaturated fatty acids

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

DRUG

Aspirin

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

Sponsors & Collaborators

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    lead OTHER

Principal Investigators

  • Mauro Santamaria, Professor · Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2018-10-01
Completion
2020-06-29

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093207 on ClinicalTrials.gov