| CTRI Number |
CTRI/2018/08/015263 [Registered on: 09/08/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of omega 3 fatty acid in gum disease |
|
Scientific Title of Study
|
"efficacy of omega 3 fatty acid as an adjunct in managing chronic moderate periodontitis compared to subgingival scaling and root planning ";a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr shirish kumar kujur |
| Designation |
Junior resident |
| Affiliation |
govt dental college trivandrum |
| Address |
Depsrtment of periodontics,govt dental college trivandrum,kerala 695011 india
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7736592927 |
| Fax |
|
| Email |
shirishtirkey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BinduRNayar |
| Designation |
professor and head |
| Affiliation |
govt dental college trivandrum |
| Address |
Department of periodontics,govt dental college,room no 32,trivandrum,kerala 695011 india
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7736592927 |
| Fax |
|
| Email |
brnsai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shirish kumar kujur |
| Designation |
Junior resident |
| Affiliation |
govt dental college trivandrum |
| Address |
Depsrtment of periodontics,govt dental college trivandrum,kerala 695011 india
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7736592927 |
| Fax |
|
| Email |
shirishtirkey@gmail.com |
|
|
Source of Monetary or Material Support
|
| INLIFE PHARMACEUTICALS PVT. LIMITED HYDERABAD |
|
|
Primary Sponsor
|
| Name |
Dr shirish kumar kujur |
| Address |
Department of periodontics,govt dental college trivandrum,kerala 695011 |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| dr shirish kumar kujur |
government dental college trivandrum |
department of periodontics,room no 32.
Thiruvananthapuram
KERALA |
9399093749
shirishtirkey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee govt dental college trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
scaling and root planning |
scaling and root planning |
| Intervention |
omega 3 fatty acid ethyl esters |
omega 3 fatty acid ethyl esters containing eicosapentanoic acid and docasahexanoic acid for one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with chronic moderate periodontitis having probing pocket depth (3 - 5 mm) |
|
| ExclusionCriteria |
| Details |
1.pregnancy and lactation
2.history of any drug intake |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcome is the reduction in pocket depth upto 1mm in 3 month |
outcome is the reduction in pocket depth upto 1mm in 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| n/a |
n/a |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/07/2014 |
| Date of Study Completion (India) |
14/10/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients with chronic moderate periodontitis having probing pocket depth (3 -5mm) will be taken for study. They will be randomly allocated into two groups, case and control group.. scaling and root planning followed by medication (omega 3 fatty acid for 1 month) will be given to the patients of case group and control group will be provided scaling and root planning only. follow up will be done at 1 and 4 month to check periodontal measurements.
|