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

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ClinicalTrials.gov Identifier: NCT03599401
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rampally Prathyusha, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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

Condition or disease Intervention/treatment Phase
Periodontitis Type2 Diabetes Other: Scaling and root planing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Sealed Envelopes
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Other: Scaling and root planing

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

.

Other Name: Nonsurgical periodontal therapy

Active Comparator: 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.
Other: Scaling and root planing

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

.

Other Name: Nonsurgical periodontal therapy

Placebo Comparator: 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.
Other: Scaling and root planing

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

.

Other Name: Nonsurgical periodontal therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599401


Locations
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India
Panineeya Mahavidhyalaya Institute of Dental Sciences
Hyderabad, Telangana, India, 500060
Sponsors and Collaborators
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Investigators
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Principal Investigator: Prathyusha Rampally, MDS Panineeya Mahavidhyalaya Institute of Dental Sciences

Publications:
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Responsible Party: Rampally Prathyusha, Student, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT03599401     History of Changes
Other Study ID Numbers: PERIO
D159206042 ( Other Identifier: Dr. N T R UNIVERSITY OF HEALTH SCIENCES )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspirin
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics