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Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Aggressive Periodontitis

NCT03093246 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-12-28

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 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.

Conditions

  • Aggressive Periodontitis

Interventions

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

OTHER

Placebo

Placebo pills over a period of 180 days

PROCEDURE

Full-mouth ultrasonic debridement

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

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
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2018-10-01
Completion
2019-12-13

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 NCT03093246 on ClinicalTrials.gov