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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Chronic Periodontitis

Intervention / Treatment
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* Drug: Placebo
* Drug: 3g omega-3 plus 100mg aspirin daily for 60 days
* Drug: omega-3 plus aspirin before periodontal therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Full-mouth periodontal debridement and placebo | Drug: Placebo<br>* One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention<br>|
| Active Comparator: Test 1<br>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<br>* Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy<br>* Other names: acetylsalicylic acid;|
| Active Comparator: Test 2<br>omega-3 plus aspirin before periodontal therapy | Drug: omega-3 plus aspirin before periodontal therapy<br>* Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy<br>* Other names: acetylsalicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal pockets with mean probing depth (PD) ≥5mm |  | Baseline, 90 days, 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth (mm) | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) | Baseline, 90 days, 180 days | 
| Clinical attachment level (mm) | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) | Baseline, 90 days, 180 days | 
| Gingival recession (mm) | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) | Baseline, 90 days, 180 days | 
| Bleeding on probing (%) | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) | Baseline, 90 days, 180 days | 
| Plaque index (%) | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) | Baseline, 90 days, 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement