Phase 3
N=34
Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis
Residual Disease · Aggressive Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT03093207 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Clinical Attachment Level at Baseline, 3 Months and 6 Months — 5.5; 5.29; 4.64; 4.73 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Open flap debridement (Procedure); Placebo (Other); Omega-3 polyunsaturated fatty acids (Dietary_supplement); Aspirin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Attachment Level at Baseline, 3 Months and 6 Months |
5.5; 5.29; 4.64; 4.73; 4.64; 4.97 | — |
| SECONDARY Probing Depth at Baseline, 3 Months and 6 Months |
5.17; 5.14; 4.08; 3.76; 4; 3.94 | — |
| SECONDARY Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months |
100; 100; 76.47; 100; 64.7; 64.7 | — |
Summary
The aim of this randomized controlled clinical trial of superiority will be to evaluate the effect of 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily supplementation over a period of 180 days as adjunct to surgical therapy of residual pockets from patients with generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6 months after the procedure will be evaluated.
Eligibility Criteria
Inclusion criteria
- Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
- Good general health;
- Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Exclusion Criteria
- Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- Have used antibiotics and anti-inflammatories in the last six months;
- Smoke ≥ 10 cigarettes/day;
- Pregnant or nursing;
- Chronic use of medications that may alter the response of periodontal tissues;
- Indication of antibiotic prophylaxis for dental procedures;
- History of allergic reaction to acetylsalicylic acid, fish or seafood.
Data sourced from ClinicalTrials.gov (NCT03093207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.