| CTRI Number |
CTRI/2025/04/083877 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Changes in saliva in skin diseases(psoriasis) patients with gum disease. |
|
Scientific Title of Study
|
ASSESSING INTERLEUKIN-1B LEVELS IN PSORIASIS PATIENTS WITH AND WITHOUT CHRONIC PERIODONTITIS: A CROSS-SECTIONAL 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 |
Arya Mishra |
| Designation |
Posgraduate student |
| Affiliation |
Institute of dental sciences |
| Address |
Room no 228 Department of periodontology and implantology Institute of dental sciences Pilibhit bypass road bareilly
Bareilly
UTTAR PRADESH
243001
India |
| Phone |
9534586262 |
| Fax |
|
| Email |
Arykmish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rika singh |
| Designation |
Head & professor Periodontology & Implantology |
| Affiliation |
Institute of dental sciences |
| Address |
Room no228 Department of periodontology and implantology Institute of dental sciences Pilibhit by paas road bareilly
Bareilly
UTTAR PRADESH
243001
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
Rikasingh22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rika singh |
| Designation |
Head & professor Periodontology & Implantology |
| Affiliation |
Institute of dental sciences |
| Address |
Room no228 Department of periodontology and implantology Institute of dental sciences Pilibhit by paas road bareilly
UTTAR PRADESH
243001
India |
| Phone |
9458411133 |
| Fax |
|
| Email |
Rikasingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Arya Mishra |
| Address |
Room no 228 Department of periodontology and implantology Institute of dental sciences Pilibhit bypass road bareilly 243006 |
| Type of Sponsor |
Other [self] |
|
|
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 Arya Mishra |
Institute of dental sciences bareilly |
Room no 228 Department of periodontology and implantology Institute of dental sciences Pilibhit bypass road bareilly
Bareilly
UTTAR PRADESH |
0581-2526244
Arykmish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Dental Sciences, Bareilly, UP |
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 |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient dignosed with psoriasis
Patitients with chronic periodontitis having psoriasis
Patients without chronic periodontitis having psoriasis
|
|
| ExclusionCriteria |
| Details |
Smokers suffer from psoriasis.
Patients with other systemic diseases & co- morbidities.
Patient received treatment for periodontitis in past 6-months.
Patients on systemic antibiotic therapy in past 6-months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| il-1B elevated in psoriasis patient with chronic periodontitis |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
07/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2025 |
| 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
|
In recent days, the potential links between periodontitis and immune-mediated inflammatory diseases have attracted increasing scrutiny. Studies suggests that bacterial growth in oral cavity could spark an overactive immune response in those prone to such conditions, leading to continuous inflammation associated with autoimmune disorders such as psoriasis. There are controversial studies regarding the role of IL-1β in pathogenesis of psoriasis & periodontitis & their association.in accordance with this, the goal of my study will be to evaluate and compare the levels of IL-1β in psoriasis patients with & without chronic periodontitis. |