| CTRI Number |
CTRI/2025/04/085343 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Changes in proinflamatory marker before and after treatment of pyrea |
|
Scientific Title of Study
|
Evaluating Interleukin 21 Levels in Chronic Periodontitis Patients Before and After Periodontal Therapy A Clinical Study |
| 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 Mayank Awasthi |
| Designation |
post graduate |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Room no.223, Department of Periodontology,Institute of Dental sciences ,pilibhit bypass road,bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7457010115 |
| Fax |
|
| Email |
mayank94155@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences ,Bareilly |
| Address |
Room no.223, Department of Periodontology,Institute of Dental Sciences ,Pilibhit Bypass Road,Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rika Singh |
| Designation |
Professor |
| Affiliation |
Institute of dental sciences ,bareilly |
| Address |
Room no.223 Department of Periodontology,Institute of dental sciences ,pilibhit bypass road,bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
rikasingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences, BAREILLY, Pilibhit bypass road, bareilly, u.p. , 243006 |
|
|
Primary Sponsor
|
| Name |
Institute of dental sciences |
| Address |
Room no.223 Department of Periodontology,Institute of dental sciences ,pilibhit bypass road,bareilly |
| Type of Sponsor |
Other [Dental college] |
|
|
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 Rika singh |
Institute of dental sciences, bareilly |
room no 223 department of periodontology institute of dental sciences pilibhit bypass road bareilly
Bareilly
UTTAR PRADESH |
9458411133
rikasingh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IDS Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
interlukin 21 |
checking the level of interlukin 21 after 7 days of scaling |
| Intervention |
scaling & root planning |
Checking interlukin 21 before intervention |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ï‚·Age Group 20-60 with minimum 15 functional teeth
ï‚·Bleeding on probing at least 30 percent of the time.
ï‚·Periodontal pocket depth greater than equal to 5mm
ï‚·Clinical attachment level greater than equal to 4mm |
|
| ExclusionCriteria |
| Details |
pregnant or lactating
individuals with any type of systemic ailment
patient who have been taking alcohol or smoking tobacoo
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesing interlukin 21 level in saliva sample of chronic periodontitis patient before and after scaling and root planning |
0 day , 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
21/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The current study was intended to estimate IL-21 in the saliva samples of chronic periodontitis patients before and after periodontal therapy & determine its diagnostic utility aid in periodontal disease & systemic diseases.1 Hence, the present study will be undertaken to assess IL-21 levels in chronic periodontitis patients before & after periodontal therapy i.e; scaling & root planning.
|