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

NCT03599401 | Completed DMC

• 2 other identifiers: PERIOD159206042
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis; Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Gingival Index

  Base line and 3 months after scaling and root planning

• Change in Pocket Probing Depth

  Base line and 3 months after scaling and root planning

• Change in Clinical attachment level

  Base line and 3 months after scaling and root planning

Study Arms (3)

Aspirin Group (Group I)

ACTIVE COMPARATOR

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

Omega 3 Fatty acid Group (Group II)

ACTIVE COMPARATOR

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

Placebo Group (Group III)

PLACEBO COMPARATOR

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

Interventions

Scaling and root planing OTHER

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

Also known as: Nonsurgical periodontal therapy

Aspirin Group (Group I); Omega 3 Fatty acid Group (Group II); Placebo Group (Group III)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Type II Diabetes
• Patients with Chronic periodontitis.
• Clinical attachment loss ≥ 4 mm
• Probing depths ≥ 5mm.
• teeth should be present
• Diabetic patients having HbA1C levels ≥ 6%

You may not qualify if:

• 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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineeya Mahavidhyalaya Institute of Dental Sciences

Hyderabad, Telangana, 500060, India

Location

Related Publications (2)

• 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.

  PMID: 25604769 BACKGROUND

• 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.

  PMID: 21080790 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Prathyusha Rampally, MDS

  Panineeya Mahavidhyalaya Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sealed Envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: 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

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 26, 2018
• Study Start: October 15, 2016
• Primary Completion: January 15, 2017
• Study Completion: March 21, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)