Clinical trial NCT03599401: Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Type2 Diabetes
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Plasma Pentraxin 3 levels
timeFrame: Base line and 3 months after scaling and root planning
measure: Change in Glycosylated Hemoglobin levels
timeFrame: Base line and 3 months after scaling and root planning
Secondary outcomes:
measure: Change in Gingival Index
timeFrame: Base line and 3 months after scaling and root planning
measure: Change in Pocket Probing Depth
timeFrame: Base line and 3 months after scaling and root planning
measure: Change in Clinical attachment level
timeFrame: Base line and 3 months after scaling and root planning
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Mahavidhyalaya Institute of Dental Sciences
state: Telangana
Study officials:
affiliation: Panineeya Mahavidhyalaya Institute of Dental Sciences
name: Prathyusha Rampally, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.