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Omega-3 and Aspirin with Antibiotics to treat Gum Disease in people with Diabetes

Omega-3 and Aspirin associated with Systemic Antibiotics in the periodontal treatment of patients with type 2 Diabetes Mellitus: local and systemic effects, immunological actions, and impact on oral and gut microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10xprdbk
Enrollment
Unknown
Registered
2025-02-24
Start date
2021-10-06
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

Type 2 Diabetes

Interventions

It's a double-blind, three-arm parallel, randomized clinical trial. Experimental group 1: 41 participants with periodontitis and type 2 diabetes mellitus will receive non-surgical periodontal treatmen

Sponsors

Universidade Guarulhos
Lead Sponsor
Universidade Guarulhos
Collaborator

Eligibility

Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: Stages III and IV Periodontitis; Grades B and C Periodontitis; type 2 Diabetes Mellitus; at least 15 teeth; 30 years and over; males and females

Exclusion criteria

Exclusion criteria: Smokers; pregnant women; lactating women; history of periodontal treatment in the last 6 months; continuous use of oral antiseptics, use of systemic antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants, estrogen and estrogen receptor modulators, drugs that can influence the bone metabolism (Alendronate, Calcitonin and others) in the last 6 months; continuous use of medication; need for prophylactic medication for dental treatment (eg mitral valve prolapse); report of allergy to Metronidazole, Amoxicillin (as well as any other penicillin), Aspirin or fish/seafood; use of braces; extensive prosthetic rehabilitations; blood dyscrasias; gastritis or gastric ulcer

Design outcomes

Primary

MeasureTime frame
Comparison between the percentage of patients that achieved the endpoint for periodontal treatment and did not achieve the endpoint for periodontal treatment assessed through periodontal clinical examination.

Secondary

MeasureTime frame
Observe probing depth reduction, clinical attachment gain, mean bleeding on probing reduction, and mean plaque index reduction measured through periodontal clinical examination. And glycated hemoglobin levels reduction to assess the impact of periodontal treatment on diabetes control through biclinical exam.

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)