Effects of Omega-3 and Aspirin, with or without Antibiotics, in the treatment of Severe Gum Disease

Clinical and microbiological effects of Immune modulation, with or without Systemic Antibiotics, in the treatment of Periodontitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7nh566t

Enrollment

Unknown

Registered

2025-02-24

Start date

2021-09-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Interventions

This is a four-arm, double-blind, randomized controlled clinical trial. Randomization was performed as follows: a random sequence was computer generated to randomly allocate patients into groups.This

(ii) Test Group 1: 50 patients with periodontitis will receive SRP in 2 sessions in combination with 400mg metronidazole (MTZ) and 500mg amoxicillin (AMX) for 14 days (Test Group 1) (n=50)

(iii) Test Group 2: 50 patients with periodontitis will receive SRP in 2 sessions in combination with 3g omega (?) -3 and 100mg aspirin (ASA) for 6 months

(iv) Test Group 3: 50 patients with periodontitis will receive SRP in 2 sessions in combination with 400mg MTZ and 500mg AMX for 14 days associated with 3g ?-3 and 100mg ASA for 6 months. All voluntee

D10.251

D02.455.426.559.389.657.410.595.176

Eligibility

Age

30 Years to No maximum

Inclusion criteria

Inclusion criteria: Severe periodontitis; at least 15 teeth; aged over 29 years; males and females

Exclusion criteria

Exclusion criteria: Smokers; former smokers for at least 5 years; pregnant or lactating women; history of periodontal treatment in last 6 months; continuous use of oral antiseptics; use of systemic antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants, estrogen, and estrogen receptor modulators; medicines that may influence bone metabolism, such as alendronate, calcitonin, and others, in the last 6 months; continuous use of medications; a systemic disease that may alter the response to periodontal or requiring prophylactic medication for dental treatment; report of allergy to metronidazole or amoxicillin, aspirin or fish and seafood; use of orthodontic appliances; prostheses; blood dyscrasias, gastritis or gastric ulcer

Design outcomes

Primary

Measure	Time frame
Percentage of volunteers who achieve at most 4 periodontal pockets at 6 months after treatment.	—

Secondary

Measure	Time frame
Clinical attachment gain in the periodontal pockets of at least 1mm 6 months after the treatment.;Reduction of the pocket depth of at least 1 mm 6 months after the treatment.	—

Countries

Brazil

Contacts

Public ContactNidia Castro dos Santos

Universidade Guarulhos

nidia.castro@ymail.com+55 (12) 99102-1346

Outcome results

None listed

Source: REBEC (via WHO ICTRP)