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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Periodontitis, Type2 Diabetes

Intervention / Treatment
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* Other: Scaling and root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

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

What is the study measuring?
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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 |