Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
Periodontal pockets with mean probing depth (PD) ≥5mm [ Time Frame: Baseline, 90 days, 180 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02800252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • Probing depth (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
  • Clinical attachment level (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
  • Gingival recession (mm) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
  • Bleeding on probing (%) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
  • Plaque index (%) [ Time Frame: Baseline, 90 days, 180 days ]
    Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • Probing depth [ Time Frame: Baseline, 90 days, 180 days ]
  • Clinical attachment level [ Time Frame: Baseline, 90 days, 180 days ]
  • Gingival recession [ Time Frame: Baseline, 90 days, 180 days ]
  • Bleeding on probing [ Time Frame: Baseline, 90 days, 180 days ]
  • Plaque index [ Time Frame: Baseline, 90 days, 180 days ]
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2016)
Glycated hemoglobin [ Time Frame: Baseline, 180 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Chronic Periodontitis
Intervention  ICMJE
  • Drug: Placebo
    One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    Full-mouth periodontal debridement and placebo
    Intervention: Drug: Placebo
  • Active Comparator: Test 1
    Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
    Intervention: Drug: 3g omega-3 plus 100mg aspirin daily for 60 days
  • Active Comparator: Test 2
    omega-3 plus aspirin before periodontal therapy
    Intervention: Drug: omega-3 plus aspirin before periodontal therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800252
Other Study ID Numbers  ICMJE NCSFOSJC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
Study Sponsor  ICMJE Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Study Director: Mauro P Santamaria, PhD UPECLIN HC FM Botucatu Unesp
PRS Account Universidade Estadual Paulista Júlio de Mesquita Filho
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP