Periodontal Disease, Periodontitis (Stage 3), Smoking Behaviors
Conditions
Keywords
omega 3, smoker, stage 3
Brief 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
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
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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind placebo-controlled study. Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline, 3 Months, and 6 Months | Mean change in probing pocket depth measured in millimeters at six sites per tooth. |
| Change in Clinical Attachment Level (CAL) | Baseline, 3 Months, and 6 Months | Mean gain in clinical attachment level measured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin-1 Beta (IL-1β) Levels | Baseline, 3 Months, and 6 Months | Changes in gingival crevicular fluid IL-1β levels assessed using ELISA. |
Countries
Egypt
Contacts
CONTACTALAA hesham mah,oud, BDS, MSc Candidate
PRINCIPAL_INVESTIGATORnaglaa M EL wakeel, professor
Faculty of Dental Medicine for Girls, Al-Azhar University
Outcome results
None listed