Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis (EAOFASRPDMCP)
Primary Purpose
Periodontitis, Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
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
Sites / Locations
- Panineeya Mahavidhyalaya Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Aspirin Group (Group I)
Omega 3 Fatty acid Group (Group II)
Placebo Group (Group III)
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in Gingival Index
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
Change in Pocket Probing Depth
The distance from the gingival margin to the base of the pocket was measured in millimeters using Williams periodontal probe
Change in Clinical attachment level
The distance from the cemento-enamel junction to the alveolar crest was measured in millimeters using Williams periodontal probe.
Full Information
NCT ID
NCT03599401
First Posted
July 10, 2018
Last Updated
July 23, 2018
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT03599401
Brief Title
Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis
Acronym
EAOFASRPDMCP
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2016 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
March 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Sealed Envelopes
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin Group (Group I)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Omega 3 Fatty acid Group (Group II)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group (Group III)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
Nonsurgical periodontal therapy
Intervention Description
Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination.
.
Primary Outcome Measure Information:
Title
Change in Plasma Pentraxin 3 levels
Description
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
Time Frame
Base line and 3 months after scaling and root planning
Title
Change in Glycosylated Hemoglobin levels
Description
Blood samples were collected by venepuncture of anti-cubital vein. 1ml of blood was collected and was used for glycosylated hemoglobin (HbA1c) estimation
Time Frame
Base line and 3 months after scaling and root planning
Secondary Outcome Measure Information:
Title
Change in Gingival Index
Description
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
Time Frame
Base line and 3 months after scaling and root planning
Title
Change in Pocket Probing Depth
Description
The distance from the gingival margin to the base of the pocket was measured in millimeters using Williams periodontal probe
Time Frame
Base line and 3 months after scaling and root planning
Title
Change in Clinical attachment level
Description
The distance from the cemento-enamel junction to the alveolar crest was measured in millimeters using Williams periodontal probe.
Time Frame
Base line and 3 months after scaling and root planning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prathyusha Rampally, MDS
Organizational Affiliation
Panineeya Mahavidhyalaya Institute of Dental Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panineeya Mahavidhyalaya Institute of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25604769
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.
Results Reference
background
PubMed Identifier
21080790
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.
Results Reference
background
Learn more about this trial
Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis
We'll reach out to this number within 24 hrs