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

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Status: Completed

Conditions: Periodontitis; Type2 Diabetes

Treatments: Other: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT03599401

PERIO

D159206042 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

Aspirin Group (Group I)

Active Comparator group

Description:

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

Treatment:

Other: Scaling and root planing

Omega 3 Fatty acid Group (Group II)

Active Comparator group

Description:

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.

Treatment:

Other: Scaling and root planing

Placebo Group (Group III)

Placebo Comparator group

Description:

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.

Treatment:

Other: Scaling and root planing