Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093246
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : June 4, 2019
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 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.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Dietary Supplement: Omega-3 polyunsaturated fatty acids Drug: Aspirin Other: Placebo Procedure: Full-mouth ultrasonic debridement Phase 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 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 Non-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
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
In this group (n = 19), patients will take placebo pills and full-mouth ultrasonic debridement will be performed to treat diseased sites.
Other: Placebo
Placebo pills over a period of 180 days

Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement

Experimental: Test Group
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
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

Procedure: Full-mouth ultrasonic debridement
Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
Other Name: Periodontal debridement




Primary Outcome Measures :
  1. Change in probing depth [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months PB measures.


Secondary Outcome Measures :
  1. Change in clinical attachment level [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months CAL measures.

  2. Change in bleeding on probe [ Time Frame: Baseline, 3 and 6 months ]
    Evaluate the difference between baseline and 6 months BoP measures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

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): NCT03093246


Contacts
Layout table for location contacts
Contact: Cássia Araujo, DDS, MS 55 12 99635-0655 cassia.araujo@gmail.com

Locations
Layout table for location information
Brazil
College of Dentistry - São José dos Campos, Sao Paulo State University Recruiting
Sao Jose dos Campos, SP, Brazil, 12245-310
Contact: Cássia F Araujo, DDS, MS    55 12 99635-0655    cassia.araujo@gmail.com   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
Layout table for investigator information
Principal Investigator: Mauro Santamaria, Professor Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Publications:
Layout table for additonal information
Responsible Party: Mauro Pedrine Santamaria, PhD Adjunt professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03093246     History of Changes
Other Study ID Numbers: HMT+UPD CFA
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Full-mouth ultrasonic debridement
Aspirin
Omega-3 polyunsaturated fatty acids
Non-surgical therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
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