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NCT Number: NCT03599401

Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing 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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases Type2 Diabetes

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panineeya Mahavidhyalaya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and root planing

Other

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

.

Other names: Nonsurgical periodontal therapy

Primary outcomes

  1. Change in Plasma Pentraxin 3 levels

    Time frame: Base line and 3 months after scaling and root planning

    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

  2. Change in Glycosylated Hemoglobin levels

    Time frame: Base line and 3 months after scaling and root planning

    Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected and was used for glycosylated hemoglobin (HbA1c) estimation

Secondary outcomes

  1. Change in Gingival Index

    Time frame: Base line and 3 months after scaling and root planning

    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

  2. Change in Pocket Probing Depth

    Time frame: Base line and 3 months after scaling and root planning

    The distance from the gingival margin to the base of the pocket was measured in millimeters using Williams periodontal probe

  3. Change in Clinical attachment level

    Time frame: Base line and 3 months after scaling and root planning

    The distance from the cemento-enamel junction to the alveolar crest was measured in millimeters using Williams periodontal probe.

Sponsors and collaborators

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Other

Registry information

Official study 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

Acronym: EAOFASRPDMCP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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