Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
Effects of Omega-3 Polyunsaturated Fatty Acids Daily Supplementation Plus Low-dose Aspirin as Adjunct to Full-mouth Periodontal Ultrasonic Debridement for the Treatment of Chronic Periodontitis in Type 2 Diabetics: Randomized Clinical Trial
1 other identifier
interventional
75
1 country
1
Brief Summary
Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jun 2016
Typical duration for not_applicable diabetes-mellitus
1 active site
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
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 23, 2016
November 1, 2016
2.5 years
June 10, 2016
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Periodontal pockets with mean probing depth (PD) ≥5mm
Baseline, 90 days, 180 days
Secondary Outcomes (5)
Probing depth (mm)
Baseline, 90 days, 180 days
Clinical attachment level (mm)
Baseline, 90 days, 180 days
Gingival recession (mm)
Baseline, 90 days, 180 days
Bleeding on probing (%)
Baseline, 90 days, 180 days
Plaque index (%)
Baseline, 90 days, 180 days
Other Outcomes (1)
Glycated hemoglobin
Baseline, 180 days
Study Arms (3)
Control Group
PLACEBO COMPARATORFull-mouth periodontal debridement and placebo
Test 1
ACTIVE COMPARATORFull-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Test 2
ACTIVE COMPARATORomega-3 plus aspirin before periodontal therapy
Interventions
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
Eligibility Criteria
You may qualify if:
- a) Age ≥35 b) diagnosis of type 2 DM for ≥5 years c) DM treatment with oral hypoglycemic agents or insulin supplementation and diet d) glycated hemoglobin (HbA1c) levels from 6.5% to 11% e) at least 15 teeth (excluding third molars and teeth indicated for extraction) f) moderate to severe generalized chronic periodontitis (Armitage, 1999) g) agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who is not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
You may not qualify if:
- a) medical conditions that required prophylactic antimicrobial coverage b) scaling and root planing in the previous 6 months c) antimicrobial therapies in the previous 6 months d) anti-inflammatory therapies in the previous 6 months e) systemic conditions, other than DM, that could affect the progression of chronic periodontitis f) current use of medication that could interfere with periodontal response to treatment g) pregnancy or lactation h) smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNESP
São José dos Campos, São Paulo, 12245-000, Brazil
Related Publications (3)
El-Sharkawy H, Aboelsaad N, Eliwa M, Darweesh M, Alshahat M, Kantarci A, Hasturk H, Van Dyke TE. Adjunctive treatment of chronic periodontitis with daily dietary supplementation with omega-3 Fatty acids and low-dose aspirin. J Periodontol. 2010 Nov;81(11):1635-43. doi: 10.1902/jop.2010.090628. Epub 2010 Jun 23.
PMID: 20572767RESULTCastro Dos Santos N, Mangussi A, Ribeiro T, Silva RNB, Santamaria MP, Feres M, VAN Dyke T, Lorena AC. Factors influencing the response to periodontal therapy in patients with diabetes: post hoc analysis of a randomized clinical trial using machine learning. J Appl Oral Sci. 2025 Jul 25;33:e20250211. doi: 10.1590/1678-7757-2025-0211. eCollection 2025.
PMID: 40736087DERIVEDDos Santos NC, Araujo CF, Andere NMRB, Miguel MMV, Westphal MRA, Van Dyke T, Santamaria MP. Omega-3 Fatty Acids and Low-Dose Aspirin in the Treatment of Periodontitis and Metabolic Syndrome: Case Report. J Int Acad Periodontol. 2020 Oct 1;22(4):223-230.
PMID: 32980834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mauro P Santamaria, PhD
UPECLIN HC FM Botucatu Unesp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, MS
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 15, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 23, 2016
Record last verified: 2016-11