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Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis (OASP)

6. juli 2026 opdateret af: Alaa hesham Mahmoud, Al-Azhar University

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

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
      • Cairo, Egypten, 11651
        • Rekruttering
        • Faculty of Dental Medicine for Girls, Al-Azhar University
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Omega-3 Plus Low-Dose Aspirin
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.
Medicin: 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
Placebo komparator: Placebo Control
Participants receive scaling and root planing followed by placebo capsules for 6 months.
Medicin: Placebo
matching placebo capsules administered orally once daily for 6 months following scaling and root planning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Probing Pocket Depth (PPD)
Tidsramme: Baseline, 3 Months, and 6 Months
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)
Tidsramme: Baseline, 3 Months, and 6 Months
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)
Tidsramme: Baseline, 3 Months, and 6 Months
Mean gain in clinical attachment level measured in millimeters.
Baseline, 3 Months, and 6 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Interleukin-1 Beta (IL-1β) Levels
Tidsramme: Baseline, 3 Months, and 6 Months
Changes in gingival crevicular fluid IL-1β levels assessed using ELISA.
Baseline, 3 Months, and 6 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Al-Azhar University

Efterforskere

  • Ledende efterforsker: naglaa M EL wakeel, professor, Faculty of Dental Medicine for Girls, Al-Azhar University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2025

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

30. oktober 2026

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OMPDR-105-1u

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study includes identifiable clinical and laboratory data collected for academic research purposes only.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Periodontal sygdom

Kliniske forsøg med Omega-3 Fatty Acids (EPA plus DHA) plus low dose aspirin

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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