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
characterized by progressive destruction of the supporting structures of the teeth. Smoking is a major risk factor that increases disease severity and impairs periodontal healing. Host modulation therapy using omega-3 fatty acids and low-dose aspirin has been suggested as a promising adjunctive approach to conventional periodontal treatment due to its anti-inflammatory and pro-resolving effects. This study is a randomized, double-blind, placebo-controlled clinical trial conducted on smoker patients diagnosed with Stage III periodontitis. Participants are allocated into two groups. The test group receives scaling and root planing (SRP) followed by omega-3 fatty acids and low-dose aspirin, while the control group receives SRP and placebo. Clinical periodontal parameters including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL) are assessed at baseline, 3 months, and 6 months. Gingival crevicular fluid samples are collected for biochemical assessment of interleukin-1 beta (IL-1β) levels using ELISA Or other inflammatory markers that will be determined later. The primary objective is to evaluate changes in probing pocket depth and clinical attachment level. Secondary outcomes include changes in inflammatory biomarker levels and other periodontal clinical parameters. The findings may provide evidence regarding the efficacy of omega-3 fatty acids and low-dose aspirin as adjunctive host modulation therapy in smoker patients with Stage III periodontitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning
matching placebo capsules administered orally once daily for 6 months following scaling and root planning
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Egypt
RECRUITINGChange in Probing Pocket Depth (PPD)
Mean change in probing pocket depth measured in millimeters at six sites per tooth.
Time frame: Baseline, 3 Months, and 6 Months
Change in Probing Pocket Depth (PPD)
Mean reduction in periodontal probing pocket depth measured in millimeters at six sites per tooth.
Time frame: Baseline, 3 Months, and 6 Months
Change in Clinical Attachment Level (CAL)
Mean gain in clinical attachment level measured in millimeters.
Time frame: Baseline, 3 Months, and 6 Months
Change in Interleukin-1 Beta (IL-1β) Levels
Changes in gingival crevicular fluid IL-1β levels assessed using ELISA.
Time frame: Baseline, 3 Months, and 6 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.