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Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics

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ClinicalTrials.gov Identifier: NCT02800252
Recruitment Status : Unknown
Verified November 2016 by Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Periodontitis Drug: Placebo Drug: 3g omega-3 plus 100mg aspirin daily for 60 days Drug: omega-3 plus aspirin before periodontal therapy Not Applicable

Detailed Description:
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2040, 642 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2015). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetic patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. As a host modulatory therapy (HMT), the daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin has been proposed as adjunct therapy to the treatment of chronic periodontitis, showing good clinical and metabolic results in normoglycemic patients. Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Omega-3 Polyunsaturated Fatty Acids Daily Supplementation Plus Low-dose Aspirin as Adjunct to Full-mouth Periodontal Ultrasonic Debridement for the Treatment of Chronic Periodontitis in Type 2 Diabetics: Randomized Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
Full-mouth periodontal debridement and placebo
Drug: Placebo
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention

Active Comparator: Test 1
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Drug: 3g omega-3 plus 100mg aspirin daily for 60 days
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Other Names:
  • omega-3 polyunsaturated fatty acids
  • acetylsalicylic acid

Active Comparator: Test 2
omega-3 plus aspirin before periodontal therapy
Drug: omega-3 plus aspirin before periodontal therapy
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
Other Names:
  • omega-3 polyunsaturated fatty acids
  • acetylsalicylic acid




Primary Outcome Measures :
  1. Periodontal pockets with mean probing depth (PD) ≥5mm [ Time Frame: Baseline, 90 days, 180 days ]

Secondary Outcome Measures :
  1. Probing depth (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)

  2. Clinical attachment level (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)

  3. Gingival recession (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)

  4. Bleeding on probing (%) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)

  5. Plaque index (%) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)


Other Outcome Measures:
  1. Glycated hemoglobin [ Time Frame: Baseline, 180 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a) Age ≥35 b) diagnosis of type 2 DM for ≥5 years c) DM treatment with oral hypoglycemic agents or insulin supplementation and diet d) glycated hemoglobin (HbA1c) levels from 6.5% to 11% e) at least 15 teeth (excluding third molars and teeth indicated for extraction) f) moderate to severe generalized chronic periodontitis (Armitage, 1999) g) agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who is not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).

Exclusion Criteria:

  • a) medical conditions that required prophylactic antimicrobial coverage b) scaling and root planing in the previous 6 months c) antimicrobial therapies in the previous 6 months d) anti-inflammatory therapies in the previous 6 months e) systemic conditions, other than DM, that could affect the progression of chronic periodontitis f) current use of medication that could interfere with periodontal response to treatment g) pregnancy or lactation h) smoking

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): NCT02800252


Contacts
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Contact: Nidia C Santos, MS 5512991021346 nidia.santos@ict.unesp.br
Contact: Mauro P Santamaria, PhD 551239479379 mauro.santamaria@ict.unesp.br

Locations
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Brazil
UNESP Recruiting
São José dos Campos, SP, Brazil, 12245-000
Contact: Nidia C Santos, MS    5512991021346    nidia.santos@ict.unesp.br   
Contact: Mauro P Santamaria, PhD    551239479379    mauro.santamaria@ict.unesp.br   
Sub-Investigator: Cássia F Araujo, DDS         
Principal Investigator: Nídia C Santos, MS         
Principal Investigator: Mauro P Santamaria, PhD         
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Mauro P Santamaria, PhD UPECLIN HC FM Botucatu Unesp

Publications of Results:
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Responsible Party: Nídia Cristina Castro dos Santos, DDS, MS, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02800252     History of Changes
Other Study ID Numbers: NCSFOSJC
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho:
fatty acids
aspirin
diabetes mellitus
chronic periodontitis
periodontal debridement
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
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