PeriodontitisEAOFASRPDMCPNCT03599401
Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis
A study testing Scaling and root planing in people with Periodontitis and Type2 Diabetes, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
The main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontitis, Type2 Diabetes
- What is being tested?
- Scaling and root planing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 15 Oct 2016to 21 Mar 2017
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type II Diabetes
- Patients with Chronic periodontitis.
- Clinical attachment loss ≥ 4 mm
- Probing depths ≥ 5mm.
- 14 teeth should be present
- Diabetic patients having HbA1C levels ≥ 6%
Who cannot join
- Pregnant and lactating women
- Smokers
- Patients with any auto immune or systemic disorder other than type II Diabetes
- Use of Medicines or antibiotic 3 months before
- History of periodontal treatment within 12 months
- Suspected intolerance to Aspirin
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidhyalaya Institute of Dental Sciences
Hyderabad, Telangana, 500060
About this study
Official title: Comparison of Effectiveness of Low Dose Aspirin Vs Omega 3 Fatty Acids as Adjuvants to Non-surgical Periodontal Therapy in Type II Diabetic Patients With Chronic Periodontitis
The main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis
Read the detailed description
There is an established bi-directional relationship between diabetes mellitus and periodontitis. Periodontitis causes systemic inflammation by the entry of oral pathogens and their virulence factors that adversely affect diabetic control in terms of elevated HbA1c levels.
Host modulatory therapy (HMT) is a strategy prescribed as an adjunct to conventional periodontal treatment by downregulating inflammation and promoting protective or regenerative responses. Different drugs have been evaluated as HMT including NSAIDS, Doxycycline, Bisphosphonates.
Aspirin has the unique position as HMT drug. It inhibits prostanoid production and induces 15- epi- lipoxins which are bioactive than native lipoxins.
Omega 3 fatty acids including Docosahexaenoic acid and Eicosapentaenoic acid due to their anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the inflammatory mediators to levels of healthy tissues.
Pentraxins(PTX3) are classic acute phase proteins. They are a superfamily of evolutionarily conserved proteins considered to be the markers of acute phase inflammation. PTX3 is also known as TNF stimulated gene. It is produced abundantly in periodontal tissue by neutrophils, fibroblasts, monocytes and epithelial cells. The plasma levels of PTX3 is raised in inflammatory conditions. Hence it is taken as a biomarker.
- Conditions
- Periodontitis, Type2 Diabetes
- Being tested
- Scaling and root planing
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingOther
Also called Nonsurgical periodontal therapy
Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination.
.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Group (Group I) | Active comparator | 14 Patients in Group I underwent scaling and root planing using ultrasonic scalers after which 75 mgms of Aspirin was administered orally, once daily for 3 months Receives: Other: Scaling and root planing |
| Omega 3 Fatty acid Group (Group II) | Active comparator | 14 Patients in Group II were given 500 mgms of Omega 3 Fatty Acid orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers. Receives: Other: Scaling and root planing |
| Placebo Group (Group III) | Placebo comparator | 14 Patients in Group III was given Placebo, which was administered orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers. Receives: Other: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Pentraxin 3 levels
Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected. 1ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (plasma) was separated into storage vial for plasma pentraxin 3
Measured: Base line and 3 months after scaling and root planning
Change in Glycosylated Hemoglobin levels
Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected and was used for glycosylated hemoglobin (HbA1c) estimation
Measured: Base line and 3 months after scaling and root planning
Secondary outcomes (3)
Change in Gingival Index
The severity of gingivitis was scored on all surfaces of selected teeth with Williams periodontal probe.Index teeth- 16, 12, 24, 36, 32, 44 .
CALCULATION:
Score around each tooth was totaled and divided by 4- score of tooth Index score- total of all scores per tooth/no. of teeth examined Inference 0.1-1.0- mild gingivitis 1.1-2.0- moderate gingivitis 2.1- 3.0- severe gingivitis
Measured: Base line and 3 months after scaling and root planning
Change in Pocket Probing Depth
The distance from the gingival margin to the base of the pocket was measured in millimeters using Williams periodontal probe
Measured: Base line and 3 months after scaling and root planning
Change in Clinical attachment level
The distance from the cemento-enamel junction to the alveolar crest was measured in millimeters using Williams periodontal probe.
Measured: Base line and 3 months after scaling and root planning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Oct 2016
- Primary completion15 Jan 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Model description
- A total of 42 subjects participated in the study. All the subjects underwent scaling and root planning and were divided into 3 groups Group 1 - low dose aspirin ( 75 mg) once daily Group 2 - omega 3 fatty acids (500 mg) twice daily Group 3 - placebo once daily
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rampally Prathyusha, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Prathyusha Rampally, MDS, Principal investigator, Panineeya Mahavidhyalaya Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599401
- Sponsor's protocol ID
- PERIO
- Other IDs
- D159206042
- Acronym
- EAOFASRPDMCP
- Status last verified
- Jul 2018
- First submitted
- 10 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elwakeel NM, Hazaa HH. Effect of omega 3 fatty acids plus low-dose aspirin on both clinical and biochemical profiles of patients with chronic periodontitis and type 2 diabetes: a randomized double blind placebo-controlled study. J Periodontal Res. 2015 Dec;50(6):721-9. doi: 10.1111/jre.12257. Epub 2015 Jan 21.
PubMed 25604769Pradeep AR, Kathariya R, Raghavendra NM, Sharma A. Levels of pentraxin-3 in gingival crevicular fluid and plasma in periodontal health and disease. J Periodontol. 2011 May;82(5):734-41. doi: 10.1902/jop.2010.100526. Epub 2010 Nov 16.
PubMed 21080790
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Low Dose Aspirin Vs Omega 3 Fatty Acids as Adjuvants to Non-surgical Periodontal Therapy in Type II Diabetic Patients With Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03599401
- Acronym / sponsor ID
- EAOFASRPDMCP / PERIO
- Conditions
- Periodontitis, Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
The main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis
Detailed description
There is an established bi-directional relationship between diabetes mellitus and periodontitis. Periodontitis causes systemic inflammation by the entry of oral pathogens and their virulence factors that adversely affect diabetic control in terms of elevated HbA1c levels.
Host modulatory therapy (HMT) is a strategy prescribed as an adjunct to conventional periodontal treatment by downregulating inflammation and promoting protective or regenerative responses. Different drugs have been evaluated as HMT including NSAIDS, Doxycycline, Bisphosphonates.
Aspirin has the unique position as HMT drug. It inhibits prostanoid production and induces 15- epi- lipoxins which are bioactive than native lipoxins.
Omega 3 fatty acids including Docosahexaenoic acid and Eicosapentaenoic acid due to their anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the inflammatory mediators to levels of healthy tissues.
Pentraxins(PTX3) are classic acute phase proteins. They are a superfamily of evolutionarily conserved proteins considered to be the markers of acute phase inflammation. PTX3 is also known as TNF stimulated gene. It is produced abundantly in periodontal tissue by neutrophils, fibroblasts, monocytes and epithelial cells. The plasma levels of PTX3 is raised in inflammatory conditions. Hence it is taken as a biomarker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A total of 42 subjects participated in the study. All the subjects underwent scaling and root planning and were divided into 3 groups Group 1 - low dose aspirin ( 75 mg) once daily Group 2 - omega 3 fatty acids (500 mg) twice daily Group 3 - placebo once daily
| Arm | Type | Receives |
|---|---|---|
| Aspirin Group (Group I) | Active comparator | Other: Scaling and root planing14 Patients in Group I underwent scaling and root planing using ultrasonic scalers after which 75 mgms of Aspirin was administered orally, once daily for 3 months |
| Omega 3 Fatty acid Group (Group II) | Active comparator | Other: Scaling and root planing14 Patients in Group II were given 500 mgms of Omega 3 Fatty Acid orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers. |
| Placebo Group (Group III) | Placebo comparator | Other: Scaling and root planing14 Patients in Group III was given Placebo, which was administered orally, twice daily for 3 months after scaling and root planing using ultrasonic scalers. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Type II Diabetes
- Patients with Chronic periodontitis.
- Clinical attachment loss ≥ 4 mm
- Probing depths ≥ 5mm.
- 14 teeth should be present
Key exclusion criteria (6 listed)
- Pregnant and lactating women
- Smokers
- Patients with any auto immune or systemic disorder other than type II Diabetes
- Use of Medicines or antibiotic 3 months before
- History of periodontal treatment within 12 months
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 |
|---|---|---|
| Scaling and root planingAlso: Nonsurgical periodontal therapyScaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination. . | Other | Aspirin Group (Group I), Omega 3 Fatty acid Group (Group II), Placebo Group (Group III) |
Primary outcome
Change in Plasma Pentraxin 3 levels
Time frame: Base line and 3 months after scaling and root planning
Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected. 1ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (plasma) was separated into storage vial for plasma pentraxin 3
Change in Glycosylated Hemoglobin levels
Time frame: Base line and 3 months after scaling and root planning
Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected and was used for glycosylated hemoglobin (HbA1c) estimation
3 secondary outcomes
Change in Gingival Index
Time frame: Base line and 3 months after scaling and root planning
Change in Pocket Probing Depth
Time frame: Base line and 3 months after scaling and root planning
Change in Clinical attachment level
Time frame: Base line and 3 months after scaling and root planning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 25604769Elwakeel NM, Hazaa HH. Effect of omega 3 fatty acids plus low-dose aspirin on both clinical and biochemical profiles of patients with chronic periodontitis and type 2 diabetes: a randomized double blind placebo-controlled study. J Periodontal Res. 2015 Dec;50(6):721-9. doi: 10.1111/jre.12257. Epub 2015 Jan 21.
- Background: PubMed 21080790Pradeep AR, Kathariya R, Raghavendra NM, Sharma A. Levels of pentraxin-3 in gingival crevicular fluid and plasma in periodontal health and disease. J Periodontol. 2011 May;82(5):734-41. doi: 10.1902/jop.2010.100526. Epub 2010 Nov 16.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Prathyusha Rampally, MDS principal investigator
Panineeya Mahavidhyalaya Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Periodontitis and Type2 Diabetes, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jul 2018. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Pentraxin 3 levels (time frame: Base line and 3 months after scaling and root planning). The study lists 2 primary outcomes in all. 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 NCT03599401, which also lists 2 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 26 Jul 2018.