Chronic Periodontitis, Diabetes Mellitus
Conditions
Keywords
fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement
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.
Interventions
DRUGPlacebo
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
DRUG3g 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
DRUGomega-3 plus aspirin before periodontal therapy
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodontal pockets with mean probing depth (PD) ≥5mm | Baseline, 90 days, 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth (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) |
| Gingival recession (mm) | Baseline, 90 days, 180 days | Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA) |
Other
| Measure | Time frame |
|---|---|
| Glycated hemoglobin | Baseline, 180 days |
Countries
Brazil
Contacts
Primary ContactNidia C Santos, MS
Backup ContactMauro P Santamaria, PhD
Outcome results
None listed