Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis

NCT03093207 | Completed Phase 2 Results

• 1 other identifier: HMT+OFD CFA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Residual Disease; Aggressive Periodontitis

Keywords

Aggressive periodontitis; Aspirin; Omega-3 polyunsaturated fatty acids; Surgical therapy

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level at Baseline, 3 Months and 6 Months

  Evaluate the difference between baseline and 6 months CAL measures. CAL: distance from bottom of sulcus/pocket to the cement-enamel junction (CEJ). The CEJ will be identified by careful probe on cervical area.

  Baseline, 3 and 6 months

Secondary Outcomes (2)

• Probing Depth at Baseline, 3 Months and 6 Months

  Baseline, 3 and 6 months

• Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months

  Baseline, 3 and 6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

In this group (n = 17), patients will take placebo pills and open flap debridement will be performed to treat residual pockets.

Procedure: Open flap debridement; Other: Placebo

Test Group

EXPERIMENTAL

In this group (n = 17), patients will take 3 g of omega-3 polyunsaturated fatty acids plus 100 mg of aspirin daily supplementation over a period of 180 days and open flap debridement will be performed to treat residual pockets.

Procedure: Open flap debridement; Dietary Supplement: Omega-3 polyunsaturated fatty acids; Drug: Aspirin

Interventions

Open flap debridement PROCEDURE

Open flap debridement will be performed to decontaminate root surface

Also known as: Surgical therapy

Control group; Test Group

Placebo OTHER

Placebo pills over a period of 180 days

Control group

Omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days

Also known as: Fish oil

Test Group

Aspirin DRUG

100 mg of aspirin daily supplementation over a period of 180 days

Also known as: acetylsalicylic acid

Test Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

College of Dentistry - São José dos Campos, Sao Paulo State University

São José dos Campos, São Paulo, 12245-310, Brazil

Location

Related Publications (1)

• 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: 20572767 BACKGROUND

MeSH Terms

Conditions

Neoplasm, Residual; Aggressive Periodontitis

Interventions

Docosahexaenoic Acids; Fish Oils; Aspirin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr Mauro Pedrine Santamaria
• Organization: São Paulo State University - Unesp

mauro.santamaria@unesp.br

+5516981937777

Study Officials

• Mauro Santamaria, Professor

  Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Adjunt professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: May 15, 2017
• Primary Completion: October 1, 2018
• Study Completion: June 29, 2020
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)