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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-15

Study Completion Date

2017-03-21

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

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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.

Conditions

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Periodontitis Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Sealed Envelopes

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type OTHER

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

.

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.

Group Type ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type OTHER

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

.

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.

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type OTHER

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

.

Interventions

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Scaling and root planing

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

.

Intervention Type OTHER

Other Intervention Names

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Nonsurgical periodontal therapy

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No