Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Aggressive Periodontitis

NCT03093246 | Completed Phase 2 Results

• 1 other identifier: HMT+UPD CFA
• Study Type: interventional
• Target: 38
• 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 non-surgical therapY of patients with generalized aggressive periodontitis. Probing depth, clinical attachment level, gingival index and concentration of microorganisms and cytokines at baseline, 3, and 6 12 months after the procedure will be evaluated.

Conditions

Aggressive Periodontitis

Keywords

Full-mouth ultrasonic debridement; Aspirin; Omega-3 polyunsaturated fatty acids; Non-surgical therapy

Outcome Measures

Primary Outcomes (1)

• Change in Probing Depth

  Evaluate the difference between baseline and 6 months PD measures.

  Baseline, 3 and 6 months

Secondary Outcomes (2)

• Change in Clinical Attachment Level

  Baseline, 3 and 6 months

• Change in Bleeding on Probe

  Baseline, 3 and 6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

In this group (n = 19), patients will take placebo pills and full-mouth ultrasonic debridement will be performed to treat diseased sites.

Other: Placebo; Procedure: Full-mouth ultrasonic debridement

Test Group

EXPERIMENTAL

In this group (n = 19), patients will take 3 g of omega-3 polyunsaturated fatty acids and 100 mg of aspirin daily over a period of 180 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.

Dietary Supplement: Omega-3 polyunsaturated fatty acids; Drug: Aspirin; Procedure: Full-mouth ultrasonic debridement

Interventions

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

Placebo OTHER

Placebo pills over a period of 180 days

Control group

Full-mouth ultrasonic debridement PROCEDURE

Full-mouth ultrasonic debridement will be performed in order to treat diseased sites

Also known as: Periodontal debridement

Control group; Test Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of GAgP (AAP, 1999);
• presence of ≥20 teeth;
• presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
• good general health;
• agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).

You may not qualify if:

• pregnancy or lactating;
• suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
• took antimicrobials in the previous 6 months;
• taking long-term anti-inflammatory drugs;
• previous periodontal treatment within the last 12 months;
• smoker ≥ 10 cigarettes.

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

Aggressive Periodontitis

Interventions

Docosahexaenoic Acids; Fish Oils; Aspirin; Periodontal Debridement

Condition Hierarchy (Ancestors)

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; Dental Prophylaxis; Periodontics; Dentistry

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: December 13, 2019
• Last Updated: December 28, 2021
• Results First Posted: July 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)