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

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

Study Overview

• Status: Completed
• Conditions: Periodontitis; Type2 Diabetes
• Intervention / Treatment: Other: Scaling and root planing

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500060
      • Panineeya Mahavidhyalaya Institute of Dental Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin Group (Group I); 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	Other: Scaling and root planing; Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination. .; Other Names: Nonsurgical periodontal therapy
Active Comparator: Omega 3 Fatty acid Group (Group II); 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.	Other: Scaling and root planing; Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination. .; Other Names: Nonsurgical periodontal therapy
Placebo Comparator: Placebo Group (Group III); 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.	Other: Scaling and root planing; Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination. .; Other Names: Nonsurgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Investigators: Principal Investigator: Prathyusha Rampally, MDS, Panineeya Mahavidhyalaya Institute of Dental Sciences

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Actual): January 15, 2017
• Study Completion (Actual): March 21, 2017

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PERIO; D159206042 (Other Identifier: Dr. N T R UNIVERSITY OF HEALTH SCIENCES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No