| CTRI Number |
CTRI/2024/10/074974 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
oral supplementation of Omega 3 fattyacids and low dose asprin in type-II diabetic patients |
|
Scientific Title of Study
|
Effect Of Omega 3 Fatty Acid and Low Dose Aspirin as An Adjunct to Periodontal Therapy in Chronic Periodontitis Patients with Type II Diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Katuri Kishore Kumar |
| Designation |
professor |
| Affiliation |
sibar institute of dental sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Gunturr
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| kishore kumar katuri
Department of Periodontology
Sibar Institute of Dental Sciences
Takellapadu
Guntur
Andhra Pradesh
India
522509 |
|
|
Primary Sponsor
|
| Name |
SIBAR Institute of dental sciences |
| Address |
department of periodontology,
sibar institute of dental sciences
takellapadu
Guntur, Andhra Pradesh. India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| katuri kishore kumar |
sibar institute of dental sciences |
department of periodontology,
sibar institute of dental sciences
takellapadu
Guntur, Andhra Pradesh. India.
Guntur
ANDHRA PRADESH |
9000534590
kishoreuga@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjunctive Effect of oral supplementation of placebo with periodontal therapy in type-II diabetic patients |
Serum CRP levels, total cholesterol, triglycerides, HDL, LDL, HbA1c and periodontal parameter will be evaluated after 3 months |
| Intervention |
Effect of oral supplementation of omega 3 fatty acid and low dose aspirin as an adjunct to periodontal therapy |
Serum CRP levels, total cholesterol, triglycerides, HDL, LDL, HbA1c and periodontal parameters will be evaluated after 3months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with age group of 30-60 years of either gender.
Stage II periodontitis with at least 6 sites with PD and CAL between 5 to 7 mm
Diagnosis of type 2 diabetes for ≥5 years
Patients under treatment for diabetes with oral hypoglycemic agents and/or insulin, with glycated hemoglobin (HbA1c) levels ≥6.5% to ≤11%
Patient who are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Smokers,
Scaling and root planing in the previous 6 months, Antimicrobial therapy in the previous 6 months; systemic conditions (other than diabetes) that could affect the progression of periodontitis
Long-term use of medication that could interfere with periodontal response
Pregnant and lactating women.
History of peptic ulcer
Allergy to fish/seafood or Low dose aspirin
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CRP levels, lipid profile, and HbA1C |
baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding on probing, probing pocket depth and clinical attachment level |
baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Omega-3 polyunsaturated fatty acids (ω-3 PUFA), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have been investigated for their therapeutic actions in rheumatoid arthritis, ulcerative colitis, atherosclerosis, cardiovascular diseases, cancer, psoriasis and periodontitis. Beneficial results were observed and attributed to the actions of specialized proresolving mediators (SPMs) biosynthesized from ω-3 PUFA (resolvins, protectins and maresins) and upregulation of endogenous SPMs (lipoxins). Studies also showed that low dose aspirin (LDA) triggers the synthesis of more potent SPMs, called aspirin-triggered resolvins, aspirin-triggered protectins, and aspirin-triggered lipoxins that have a longer half-life in blood. SPMs promote the resolution of inflammation by reducing neutrophil infiltration, regulating cytokine/chemokine synthesis, attenuating systemic C-reactive protein (CRP) and interleukin (IL)-1 production, decreasing the production of RANKL19, and regulating macrophage-secreted pro-inflammatory cytokines. Previous studies has highlighted the advantages of adjunctive oral administration of ω-3 PUFA with LDA in periodontal wound healing and inflammatory markers.
Very few studies have hypothesized that the combined treatment protocol would lead to improved periodontal and immunological outcomes when compared to periodontal debridement alone. No other study was carried out with similar observation in type -II diabetes patients till now. So, the aim of this study was to investigate periodontal and immunological effects of daily supplementation of ω-3 PUFA and 75mg LDA for 3 months as an adjunctive therapy to periodontal treatment in chronic periodontitis patients with type 2 diabetes. Total of 40 chronic periodontitis patients with type II diabetes will be recruited from the outpatient department of periodontology, Sibar institute of dental sciences, Guntur, Andhra Pradesh, India. Randomization will be carried out to divide the patients into 2 groups Group A (n=20)- oral supplementation of omega 3 fatty acid and low dose aspirin as an adjunct to periodontal therapy. Group B (n=20) oral supplementation of placebo in chronic periodontitis patients with type II diabetes. 1. Periodontal parameters (BOP,PPD,CAL) were recorded, and blood sample will be collected for measuring CRP levels, lipid profile, and HbA1C at baseline. 2. Scaling and root planning will be carried out for all the patients in both the groups 3. Oral hygiene instructions will be given. 4. Omega 3 fatty acid (100mg) and aspirin (75mg) or placebo will be given to Group A and placebo for Group B for 3months All the parameters will be recorded at baseline and 3 months.
|