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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Full-mouth periodontal debridement and placebo |
|
| Test 1 | Active Comparator | Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy |
|
| Test 2 | Active Comparator | omega-3 plus aspirin before periodontal therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal pockets with mean probing depth (PD) ≥5mm | Baseline, 90 days, 180 days |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Baseline, 180 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nidia C Santos, MS | Contact | 5512991021346 | nidia.santos@ict.unesp.br | |
| Mauro P Santamaria, PhD | Contact | 551239479379 | mauro.santamaria@ict.unesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Mauro P Santamaria, PhD | UPECLIN HC FM Botucatu Unesp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNESP | Recruiting | São José dos Campos | São Paulo | 12245-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20572767 | Result | 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. | |
| 40736087 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 22, 2019 | |
| Reset | Jul 12, 2019 |
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| 3g omega-3 plus 100mg aspirin daily for 60 days | Drug | Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy |
|
|
| omega-3 plus aspirin before periodontal therapy | Drug | Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy |
|
|
| 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 |
| Castro Dos Santos N, Mangussi A, Ribeiro T, Silva RNB, Santamaria MP, Feres M, VAN Dyke T, Lorena AC. Factors influencing the response to periodontal therapy in patients with diabetes: post hoc analysis of a randomized clinical trial using machine learning. J Appl Oral Sci. 2025 Jul 25;33:e20250211. doi: 10.1590/1678-7757-2025-0211. eCollection 2025. |
| 32980834 | Derived | Dos Santos NC, Araujo CF, Andere NMRB, Miguel MMV, Westphal MRA, Van Dyke T, Santamaria MP. Omega-3 Fatty Acids and Low-Dose Aspirin in the Treatment of Periodontitis and Metabolic Syndrome: Case Report. J Int Acad Periodontol. 2020 Oct 1;22(4):223-230. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 22, 2019 | Jul 12, 2019 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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