An interventional study of Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin and Placebo in Periodontal Disease, Periodontitis (Stage 3) and Smoking Behaviors, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
Among 12 studies in Periodontitis by Al-Azhar University — 2 open to participants now, 4 under way, 1 of them phase 3. Periodontitis · Al-Azhar University.
Among the 12 studies in Periodontitis by Al-Azhar University, this one is the 2nd largest by planned enrollment of the 10 interventional ones, is one of 5 that started in 2025, is one of 5 with no phase, and was the 9th registered.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 40 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →2 of the 12 studies in Periodontitis by Al-Azhar University are open now, in 1 country. Each count lists the studies.
Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.
This study: 30 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2025.
Median enrollment 33 across the 10 interventional studies, 220 across the 2 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Periodontitis by Al-Azhar University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 40 is close to the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periodontal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive scaling and root planing followed by omega-3 fatty acids (EPA 640 mg and DHA 480 mg daily) plus low-dose aspirin (75 mg daily) for 6 months.
Drug: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
Participants receive scaling and root planing followed by placebo capsules for 6 months.
Drug: Placebo
Drug pages: Omega-3 fatty acid · Aspirin
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
Change 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
Plan to share: No — Individual participant data will not be shared because the study includes identifiable clinical and laboratory data collected for academic research purposes only.
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Studies of the drugs tested here: Omega-3 fatty acid · Aspirin