Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis

Periodontitis Clinical Trial

— EAOFASRPDMCP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599401
• Other study ID #: PERIO
• Secondary ID: D159206042
• Status: Completed
• Phase: N/A
• Start date: October 15, 2016
• Est. completion date: March 21, 2017

Study information

• Verified date: July 2018
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 21, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Type2 Diabetes

Intervention

Other:
• Scaling and root planing
Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination.

Locations

Country	Name	City	State
India	Panineeya Mahavidhyalaya Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

Pradeep 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Base line and 3 months after scaling and root planning
Primary	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	Base line and 3 months after scaling and root planning
Secondary	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	Base line and 3 months after scaling and root planning
Secondary	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	Base line and 3 months after scaling and root planning
Secondary	Change in Clinical attachment level	The distance from the cemento-enamel junction to the alveolar crest was measured in millimeters using Williams periodontal probe.	Base line and 3 months after scaling and root planning