| CTRI Number |
CTRI/2023/07/055397 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Gene Polymoprhism of a novel Biomarker in Symptomatic Irreversible Pulpitis and Chronic Apical Periodontitis |
|
Scientific Title of Study
|
Association of NLRP3 single nucleotide polymorphism in gingival crevicular fluid of patients diagnosed with Symptomatic Irreversible Pulpitis & Chronic Apical Periodontitis in a section of the North Indian population – A case-control 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. Saumya Verma |
| Designation |
post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room number 7 department of conservative dentistry and endodonticsnManav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Room number 7 department of conservative dentistry and endodonticsnManav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9724187569 |
| Fax |
|
| Email |
saumya.mrdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dax Abraham |
| Designation |
Professor and head of department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of conservative dentistry, room no.7, second floor, Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Department of conservative dentistry, room no.7, second floor, Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dax Abraham |
| Designation |
Professor and head of department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of conservative dentistry, room no.7, second floor, Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Department of conservative dentistry, room no.7, second floor, Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.mrdc@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saumya Verma |
| Address |
Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad |
| 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 |
| Dax Abraham |
Manav Rachna dental college |
Department of conservative dentistry, room no.7, second floor, Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Rd Faridabad
Faridabad
HARYANA |
9910433111
daxabraham.mrdc@mrei.ac |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with symptomatic irreversible pulpitis according to AAE guidelines.
Patients diagnosed with chronic apical periodontitis according to AAE guidelines
Patients with no relevant history and systemic diseases.
|
|
| ExclusionCriteria |
| Details |
Patients with multiple carious teeth.
Patients with any systemic condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Single nucleotide polymorphism of NLRP3 gene is sought to be detected |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of levels of NLRP3 levels in SIP patients, CAP patients & healthy controls. |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to investigate the potential association between NLRP3 single nucleotide polymorphism (SNP) and the occurrence of symptomatic irreversible pulpitis (SIP) and chronic apical periodontitis (CAP) in a section of the North Indian population.
The study will be a case-control study in which participants diagnosed with SIP and CAP will be compared to healthy controls. Gingival crevicular fluid (GCF) samples will be collected from all participants, and NLRP3 SNPs will be analyzed using PCR-based genotyping.
The rationale behind this study is that previous research has shown that NLRP3 inflammasome activation plays a critical role in the initiation and progression of inflammatory diseases, including SIP and CAP. Moreover, it has been suggested that NLRP3 SNPs may be associated with the development and severity of these diseases. However, no studies have investigated the potential relationship between NLRP3 SNPs and SIP and CAP in the North Indian population.
The study will recruit a total of 48 participants, including 16 patients diagnosed with SIP, 16 patients diagnosed with CAP, and 16 healthy controls. The inclusion criteria for the patients will be based on standard clinical and radiographic criteria, while the exclusion criteria will include the presence of any systemic disease. All participants will be asked to sign an informed consent form. Phenotyping will be done to maintain participant confidentiality, and data will be stored securely.
Statistical analysis will be performed to assess the association between NLRP3 SNPs and SIP and CAP. The results of this study may have important clinical implications, as the analysis of NLRP3 SNPs in GCF could potentially serve as a non-invasive diagnostic marker for SIP and CAP.
In summary, this case-control study aims to investigate the potential association between NLRP3 SNPs and the occurrence of SIP and CAP in a section of the North Indian population. The results of this study may contribute to our understanding of the pathogenesis of these diseases and may have important clinical implications for the diagnosis and treatment of SIP and CAP. |