NCT07385300

Brief Summary

Background: Smoking reduces the effect of non-surgical periodontal therapy, a host modulation regimen consisting of omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation with low-dose aspirin (ASA) with or without systemic doxycycline has been proposed to improve treatment response. The Aim of the study is to explore the clinical effects of orally administered omega-3 PUFA and ASA with or without systemic doxycycline with periodontal debridement in treatment of smoker individuals with stage III periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

PeriodontitisDiabete Mellitus

Outcome Measures

Primary Outcomes (2)

  • change in probing depth

    the distance (in millimeters) from the gingival margin to the base of the gingival sulcus or periodontal pocket.

    baseline (t0) and at 3 (t1) and 6 months (t2)

  • change in clinical attachment level

    the distance (in millimeters) from the cemento-enamel junction (CEJ) to the base of the periodontal pocket.

    baseline (t0) and at 3 (t1) and 6 months (t2)

Secondary Outcomes (2)

  • change in gingival index

    baseline (t0) and at 3 (t1) and 6 months (t2)

  • change in bleeding on probing

    baseline (t0) and at 3 (t1) and 6 months (t2)

Study Arms (3)

Omega-3 PUFA and Aspirin

EXPERIMENTAL
Other: Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP)

Omega-3 PUFA and Aspirin and doxycycline

EXPERIMENTAL
Other: Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP)

Conventional

ACTIVE COMPARATOR
Other: scaling and root planning (SRP)

Interventions

Omega-3 PUFA and Aspirin and doxycycline as adjunctive therapy to (SRP)OTHER

fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) and oral dosage of doxycycline (100mg every 12 hours on day 1, then 100 mg once daily for 6 days) after periodontal debridement (TG2)

Omega-3 PUFA and Aspirin and doxycycline
scaling and root planning (SRP)OTHER

fifteen patients will receive periodontal debridement (CG)

Conventional
Omega-3 PUFA and Aspirin as adjunctive therapy to (SRP)OTHER

fifteen patients will receive ω-3 PUFA + ASA (1g of fish oil/day + 75mg ASA/day for 2 months) after periodontal debridement (TG1)

Omega-3 PUFA and Aspirin

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoker patients who smoke ≥ 10 cigarettes per day.
  • Stages III, Grades C periodontitis with at least one site with PD≥6 and CAL ≥5 mm.

You may not qualify if:

  • Scaling and root planning in the previous 6 months(that may confound the effect of treatment)
  • Antimicrobial therapy in the previous 6 months(that may confound the effect of treatment)
  • Chronic systemic diseases that may have an impact on periodontitis progression (diabetes mellitus).
  • Systemic diseases that may contraindicate aspirin or doxycycline taking (kidney and liver diseases)
  • Allergy to doxycycline
  • Long-term usage of medications that may impair periodontal health
  • Allergy to fish/seafood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

MeSH Terms

Conditions

PeriodontitisDiabetes Mellitus

Interventions

Docosahexaenoic AcidsAspirinDoxycyclineTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

August 20, 2023

Primary Completion

August 22, 2024

Study Completion

August 22, 2024

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

EG(1)