CTRI

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CTRI Number

CTRI/2023/07/055526 [Registered on: 24/07/2023] Trial Registered Prospectively

Last Modified On:

02/07/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

Gingival crevicular fluid levels of NLRP3 before and after endodontic treatment

Scientific Title of Study

Assessment of Endodontic treatment outcome based on Gingival crevicular fluid levels of NLRP3 & pain score in symptomatic irreversible pulpitis- 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	NEHA
Designation	Post Graduate student
Affiliation	Manav Rachna Dental College
Address	Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Faridabad HARYANA 121001 India
Phone	9910096337
Fax
Email	neha9910096337@gmail.com

Details of Contact Person
Scientific Query

Name	Dax Abraham
Designation	HOD AND PROFESSOR
Affiliation	Manav Rachna Dental College
Address	Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Faridabad HARYANA 121004 India
Phone	9910433111
Fax
Email	daxabraham.mrdc@mrei.ac.in

Details of Contact Person
Public Query

Name	Dax Abraham
Designation	HOD AND PROFESSOR
Affiliation	Manav Rachna Dental College
Address	Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 HARYANA 121004 India
Phone	9910433111
Fax
Email	daxabraham.mrdc@mrei.ac.in

Source of Monetary or Material Support

Department of Conservative Dentistry and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001

Primary Sponsor

Name	Neha
Address	Sector 43 Delhi Suraj Badkhal Road Faridabad Haryana
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

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 and Endodontics, Q block, Second Floor, Room number QS27 Manav Rachna Dental College,Sector 43 Delhi Surajkund Road,Faridabad, Haryana, 121001 Faridabad HARYANA	9910433111 daxabraham.mrdc@mrei.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee of Manav Rachna Dental College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K040\|\|Pulpitis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	GROUP 1 GCF sample collection of healthy individual	HEALTHY CONTROLS GCF sample collection through capillary tube method
Intervention	GROUP 2 GCF sample collection before and after root canal therapy	SYMPTOMATIC IRREVERSIBLE PULPITIS Record of pre-operative pain score will be done by using HP VAS GCF sample collection will be done after 1 week of oral prophylaxis before initiation of root canal therapy and the sample will be collected after 1 week of root canal therapy. NLRP3 level will be assessed by collecting GCF samples from patients with symptomatic irreversible pulpitis before and after root canal treatment. Comparison of NLRP3 levels will be done between healthy controls and symptomatic irreversible pulpitis patient

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	Patients diagnosed with symptomatic irreversible pulpitis as per the clinical and pulp sensibility tests and HP VAS score more than 54 Patients no relevant medical history or absence of any systemic conditions Non-smokers

ExclusionCriteria

Details

Patients with periodontitis
Patients with multiple carious teeth
Teeth with periapical radiolucencies and tender to percussion

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
NLRP3 levels in GCF may be increase & hence detectable in patients with Symptomatic Irreversible Pulpitis but will reduce after endodontic treatment	one year

Secondary Outcome

Outcome	TimePoints
Pain levels may be increase & hence detectable in patients with Symptomatic Irreversible Pulpitis but will reduce after endodontic treatment	one year

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30"

Phase of Trial

Phase 3

Date of First Enrollment (India)

01/08/2023

Date of Study Completion (India)

30/04/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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
Modification(s)

Objective: This cross-sectional study aimed to assess the outcome of endodontic treatment based on the levels of NLRP3 in gingival crevicular fluid and pain scores in patients with symptomatic irreversible pulpitis.

Methods: A total of 60 patients diagnosed with symptomatic irreversible pulpitis were included in the study. After obtaining informed consent, GCF samples were collected from the selected teeth before initiating endodontic treatment. The levels of NLRP3 in GCF were measured using enzyme-linked immunosorbent assay (ELISA). Pain scores were recorded using a visual analog scale (VAS) before and after the endodontic treatment. Descriptive statistics and correlation analysis were performed to assess the association between NLRP3 levels, pain scores, and treatment outcomes.

Results: The mean NLRP3 levels in GCF were found to be significantly higher in teeth with symptomatic irreversible pulpitis compared to healthy controls (p < 0.001). After endodontic treatment, significant reductions were observed in NLRP3 levels (p < 0.001) and pain scores (p < 0.001). Furthermore, a moderate positive correlation was found between NLRP3 levels and pain scores (r = 0.523, p < 0.001). The success rate of endodontic treatment was 86.3% based on clinical and radiographic criteria.

Conclusion: This cross-sectional study demonstrated that the levels of NLRP3 in GCF were elevated in patients with symptomatic irreversible pulpitis and showed a positive correlation with pain scores. Furthermore, the reduction in NLRP3 levels and pain scores following endodontic treatment suggests the potential role of NLRP3 as a biomarker for assessing treatment outcomes in symptomatic irreversible pulpitis. Further longitudinal studies are needed to validate these findings and explore the clinical utility of NLRP3 in endodontics.