RecruitingNot ApplicableNCT07673185

Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis

Clinical and Biochemical Evaluation of the Effect of Omega-3 Fatty Acids Plus Low-Dose Aspirin as an Adjunct to Non-Surgical Periodontal Therapy in Smoker Patients With Stage III Periodontitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial


Sponsor

Al-Azhar University

Enrollment

40 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized double-blind placebo-controlled clinical trial aims to evaluate the clinical and biochemical effects of omega-3 fatty acids combined with low-dose aspirin as an adjunct to scaling and root planing (SRP) in smoker patients with Stage III periodontitis. The study compares test and control groups regarding periodontal clinical parameters and gingival crevicular fluid interleukin-1 beta (IL-1β) levels Or other inflammatory markers that will be determined later at baseline, 3 months, and 6 months following treatment


Eligibility

Min Age: 30 YearsMax Age: 50 Years

Inclusion Criteria6

  • \- Male or female smokers aged 30 to 50 years.
  • Diagnosed with Stage III periodontitis according to the 2017 World Workshop classification.
  • Probing pocket depth (PPD) ≥ 5 mm.
  • Clinical attachment loss (CAL) ≥ 5 mm.
  • Presence of at least 20 natural teeth.
  • Willing and able to provide written informed consent.

Exclusion Criteria8

  • \- Systemic diseases affecting periodontal health.
  • Pregnancy or lactation.
  • Periodontal treatment within the previous 6 months.
  • Use of antibiotics or anti-inflammatory drugs within the previous 6 months.
  • Allergy or hypersensitivity to omega-3 fatty acids or aspirin.
  • Long-term anticoagulant therapy.
  • History of gastric ulcer or bleeding disorders.
  • Participation in another clinical trial within the previous 3 month

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Interventions

DRUGOmega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin

participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning

DRUGPlacebo

matching placebo capsules administered orally once daily for 6 months following scaling and root planning


Locations(1)

Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, Egypt

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NCT07673185


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