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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093207
Recruitment Status : Completed
First Posted : March 28, 2017
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Condition or disease Intervention/treatment Phase
Residual Disease Aggressive Periodontitis Procedure: Open flap debridement Other: Placebo Dietary Supplement: Omega-3 polyunsaturated fatty acids Drug: Aspirin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Omega-3 Polyunsaturated Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : June 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
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
Open flap debridement will be performed to decontaminate root surface
Other Name: Surgical therapy

Other: Placebo
Placebo pills over a period of 180 days

Experimental: Test Group
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
Open flap debridement will be performed to decontaminate root surface
Other Name: Surgical therapy

Dietary Supplement: Omega-3 polyunsaturated fatty acids
3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days
Other Name: Fish oil

Drug: Aspirin
100 mg of aspirin daily supplementation over a period of 180 days
Other Name: acetylsalicylic acid




Primary Outcome Measures :
  1. Clinical Attachment Level at Baseline, 3 Months and 6 Months [ Time Frame: Baseline, 3 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.


Secondary Outcome Measures :
  1. Probing Depth at Baseline, 3 Months and 6 Months [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months PB measures. PB: distance from the bottom of sulcus/pocket to gingival margin.

  2. Percentage of Sites With Bleeding on Probe at Baseline, 3 Months and 6 Months [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months BoP measures. BoP: bleeding that is induced by gentle probing of the sulcus/pocket.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093207


Locations
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Brazil
College of Dentistry - São José dos Campos, Sao Paulo State University
Sao Jose dos Campos, SP, Brazil, 12245-310
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Mauro Santamaria, Professor Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
  Study Documents (Full-Text)

Documents provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Publications:
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Responsible Party: Mauro Pedrine Santamaria, PhD Adjunt professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03093207    
Other Study ID Numbers: HMT+OFD CFA
First Posted: March 28, 2017    Key Record Dates
Results First Posted: November 17, 2020
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Aggressive periodontitis
Aspirin
Omega-3 polyunsaturated fatty acids
Surgical therapy
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics