Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
- Conditions
- Diabetes MellitusChronic Periodontitis
- Interventions
- Drug: PlaceboDrug: 3g omega-3 plus 100mg aspirin daily for 60 days
- Registration Number
- NCT02800252
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Placebo Full-mouth periodontal debridement and placebo Test 1 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 Test 2 omega-3 plus aspirin before periodontal therapy omega-3 plus aspirin before periodontal therapy
- Primary Outcome Measures
Name Time Method Periodontal pockets with mean probing depth (PD) ≥5mm Baseline, 90 days, 180 days
- Secondary Outcome Measures
Name Time Method Probing depth (mm) Baseline, 90 days, 180 days Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Gingival recession (mm) Baseline, 90 days, 180 days Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Clinical attachment level (mm) Baseline, 90 days, 180 days Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Bleeding on probing (%) Baseline, 90 days, 180 days Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Plaque index (%) Baseline, 90 days, 180 days Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Trial Locations
- Locations (1)
UNESP
🇧🇷São José dos Campos, SP, Brazil