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

Primary Purpose

Diabetes Mellitus, Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
3g omega-3 plus 100mg aspirin daily for 60 days
omega-3 plus aspirin before periodontal therapy
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control Group

Test 1

Test 2

Arm Description

Full-mouth periodontal debridement and placebo

Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy

omega-3 plus aspirin before periodontal therapy

Outcomes

Primary Outcome Measures

Periodontal pockets with mean probing depth (PD) ≥5mm

Secondary Outcome Measures

Probing depth (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Clinical attachment level (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Gingival recession (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Bleeding on probing (%)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Plaque index (%)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)

Full Information

First Posted
June 10, 2016
Last Updated
November 22, 2016
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02800252
Brief Title
Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Chronic Periodontitis
Keywords
fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Full-mouth periodontal debridement and placebo
Arm Title
Test 1
Arm Type
Active Comparator
Arm Description
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Arm Title
Test 2
Arm Type
Active Comparator
Arm Description
omega-3 plus aspirin before periodontal therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
Intervention Type
Drug
Intervention Name(s)
3g omega-3 plus 100mg aspirin daily for 60 days
Other Intervention Name(s)
omega-3 polyunsaturated fatty acids, acetylsalicylic acid
Intervention Description
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
Intervention Type
Drug
Intervention Name(s)
omega-3 plus aspirin before periodontal therapy
Other Intervention Name(s)
omega-3 polyunsaturated fatty acids, acetylsalicylic acid
Intervention Description
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
Primary Outcome Measure Information:
Title
Periodontal pockets with mean probing depth (PD) ≥5mm
Time Frame
Baseline, 90 days, 180 days
Secondary Outcome Measure Information:
Title
Probing depth (mm)
Description
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Time Frame
Baseline, 90 days, 180 days
Title
Clinical attachment level (mm)
Description
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Time Frame
Baseline, 90 days, 180 days
Title
Gingival recession (mm)
Description
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Time Frame
Baseline, 90 days, 180 days
Title
Bleeding on probing (%)
Description
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Time Frame
Baseline, 90 days, 180 days
Title
Plaque index (%)
Description
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Time Frame
Baseline, 90 days, 180 days
Other Pre-specified Outcome Measures:
Title
Glycated hemoglobin
Time Frame
Baseline, 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nidia C Santos, MS
Phone
5512991021346
Email
nidia.santos@ict.unesp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro P Santamaria, PhD
Phone
551239479379
Email
mauro.santamaria@ict.unesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Study Director
Facility Information:
Facility Name
UNESP
City
São José dos Campos
State/Province
SP
ZIP/Postal Code
12245-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nidia C Santos, MS
Phone
5512991021346
Email
nidia.santos@ict.unesp.br
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD
Phone
551239479379
Email
mauro.santamaria@ict.unesp.br
First Name & Middle Initial & Last Name & Degree
Cássia F Araujo, DDS
First Name & Middle Initial & Last Name & Degree
Nídia C Santos, MS
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20572767
Citation
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.
Results Reference
result
PubMed Identifier
32980834
Citation
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.
Results Reference
derived

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

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