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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Plus Low-Dose Aspirin | Experimental | 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. |
|
| Placebo Control | Placebo Comparator | Participants receive scaling and root planing followed by placebo capsules for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin | Drug | participants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Mean change in probing pocket depth measured in millimeters at six sites per tooth. | 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. | Baseline, 3 Months, and 6 Months |
| Change in Clinical Attachment Level (CAL) | Mean gain in clinical attachment level measured in millimeters. | Baseline, 3 Months, and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-1 Beta (IL-1β) Levels | Changes in gingival crevicular fluid IL-1β levels assessed using ELISA. | Baseline, 3 Months, and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ALAA hesham mah,oud, BDS, MSc Candidate | Contact | +201146816128 | +2 | alaahesham419@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| naglaa M EL wakeel, professor | Faculty of Dental Medicine for Girls, Al-Azhar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine for Girls, Al-Azhar University | Recruiting | Cairo | 11651 | Egypt |
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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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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This is a randomized double-blind placebo-controlled clinical trial. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. The test group receives omega-3 fatty acids plus low-dose aspirin following scaling and root planing, while the control group receives placebo following scaling and root planing.
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Double-blind placebo-controlled study. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
| Placebo | Drug | matching placebo capsules administered orally once daily for 6 months following scaling and root planning |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |