Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorAl-Azhar University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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.
Disqualifiers
- 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin
Drugparticipants receive omega3 fatty acid (EPA640+DHA480) plus low dose aspirin (75mg) orally once for 6 months following scaling and root planning
Placebo
Drugmatching placebo capsules administered orally once daily for 6 months following scaling and root planning
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Omega-3 Plus Low-Dose AspirinExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 Months2
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 Months3
Change in Clinical Attachment Level (CAL)
Mean gain in clinical attachment level measured in millimeters.
Time frame
Baseline, 3 Months, and 6 MonthsSecondary outcomes
1
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 MonthsSponsors and contacts
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Source ClinicalTrials.gov