Diabetes MellitusNCT02800252
Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
A study testing 3g omega-3 plus 100mg aspirin daily for 60 days and omega-3 plus aspirin before periodontal therapy in people with Diabetes Mellitus and Chronic Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Chronic Periodontitis
- What is being tested?
- 3g omega-3 plus 100mg aspirin daily for 60 days and omega-3 plus aspirin before periodontal therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UNESP
São José dos Campos, São Paulo, 12245-000
Nidia C Santos, MS, 5512991021346, nidia.santos@ict.unesp.br
Mauro P Santamaria, PhD, 551239479379, mauro.santamaria@ict.unesp.br
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Being tested
- Placebo, 3g omega-3 plus 100mg aspirin daily for 60 days, omega-3 plus aspirin before periodontal therapy
- Keywords
- fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement
- Medical subject headings
- Diabetes Mellitus, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
3g omega-3 plus 100mg aspirin daily for 60 daysDrug
Also called omega-3 polyunsaturated fatty acids, acetylsalicylic acid
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
omega-3 plus aspirin before periodontal therapyDrug
Also called omega-3 polyunsaturated fatty acids, acetylsalicylic acid
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Full-mouth periodontal debridement and placebo Receives: Drug: Placebo |
| Test 1 | Active comparator | Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy Receives: Drug: 3g omega-3 plus 100mg aspirin daily for 60 days |
| Test 2 | Active comparator | omega-3 plus aspirin before periodontal therapy Receives: Drug: omega-3 plus aspirin before periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pockets with mean probing depth (PD) ≥5mm
Measured: Baseline, 90 days, 180 days
Secondary outcomes (5)
Probing depth (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Measured: Baseline, 90 days, 180 days
Clinical attachment level (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Measured: Baseline, 90 days, 180 days
Gingival recession (mm)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Measured: Baseline, 90 days, 180 days
Bleeding on probing (%)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Measured: Baseline, 90 days, 180 days
Plaque index (%)
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
Measured: Baseline, 90 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, PhD, Study director, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800252
- Sponsor's protocol ID
- NCSFOSJC
- Status last verified
- Nov 2016
- First submitted
- 10 Jun 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20572767Castro 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.
PubMed 40736087Dos 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.
PubMed 32980834
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02800252
- Acronym / sponsor ID
- NCSFOSJC
- Conditions
- Diabetes Mellitus, Chronic Periodontitis
- Keywords
- fatty acids, aspirin, diabetes mellitus, chronic periodontitis, periodontal debridement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboFull-mouth periodontal debridement and placebo |
| Test 1 | Active comparator | Drug: 3g omega-3 plus 100mg aspirin daily for 60 daysFull-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy |
| Test 2 | Active comparator | Drug: omega-3 plus aspirin before periodontal therapyomega-3 plus aspirin before periodontal therapy |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOne-stage full-mouth periodontal ultrasonic debridement plus placebo intervention | Drug | Control Group |
| 3g omega-3 plus 100mg aspirin daily for 60 daysAlso: omega-3 polyunsaturated fatty acids, acetylsalicylic acidFull-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy | Drug | Test 1 |
| omega-3 plus aspirin before periodontal therapyAlso: omega-3 polyunsaturated fatty acids, acetylsalicylic acidFull-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy | Drug | Test 2 |
Primary outcome
Periodontal pockets with mean probing depth (PD) ≥5mm
Time frame: Baseline, 90 days, 180 days
5 secondary outcomes
Probing depth (mm)
Time frame: Baseline, 90 days, 180 days
Clinical attachment level (mm)
Time frame: Baseline, 90 days, 180 days
Gingival recession (mm)
Time frame: Baseline, 90 days, 180 days
Bleeding on probing (%)
Time frame: Baseline, 90 days, 180 days
Plaque index (%)
Time frame: Baseline, 90 days, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Results publication: PubMed 20572767El-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.
- Derived from this study: PubMed 40736087Castro 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.
- Derived from this study: PubMed 32980834Dos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro P Santamaria, PhD study director
UPECLIN HC FM Botucatu Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3g omega-3 plus 100mg aspirin daily for 60 days and omega-3 plus aspirin before periodontal therapy in people with Diabetes Mellitus and Chronic Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nidia C Santos, MS (5512991021346, nidia.santos@ict.unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pockets with mean probing depth (PD) ≥5mm (time frame: Baseline, 90 days, 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.