Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin, Placebo.
- Who it may be relevant to
- Registry conditions: Periodontal Disease, Periodontitis (Stage 3), Smoking Behaviors. Basic parameters: 30 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
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.
Interventions
- Drug Omega-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 - Drug Placebo
matching placebo capsules administered orally once daily for 6 months following scaling and root planning
Primary outcome measures
- Change in Probing Pocket Depth (PPD) [Time frame: Baseline, 3 Months, and 6 Months]
- Change in Probing Pocket Depth (PPD) [Time frame: Baseline, 3 Months, and 6 Months]
- Change in Clinical Attachment Level (CAL) [Time frame: Baseline, 3 Months, and 6 Months]
Secondary outcome measures (1)
- Change in Interleukin-1 Beta (IL-1β) Levels [Time frame: Baseline, 3 Months, and 6 Months]
Eligibility criteria
Inclusion criteria
- \- 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 criteria
- \- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dental Medicine for Girls, Al-Azhar University — Cairo
Identifiers
NCT: NCT07673185 · OMPDR-105-1u