| CTRI Number |
CTRI/2024/05/066690 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
NLRP3 biomarker levels before and after endodontic treatment in symptomatic apical periodontitis |
|
Scientific Title of Study
|
Comparison of gingival crevicular fluid levels of NLRP3 in patients diagnosed with pulp necrosis and symptomatic apical periodontitis before and after endodontic treatment |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karina |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room number-QS27, 2nd floor, Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS, Sector 43, Delhi, Surajkund-Badkal Road
Faridabad
HARYANA
121004
India |
| Phone |
7042676757 |
| Fax |
|
| Email |
karinasingal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dax Abraham |
| Designation |
Head of Department and Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room Number-QS21, 2nd Floor, Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS, Sector 43, Delhi, Surajkund-Badkal Road
Faridabad
HARYANA
121004
India |
| Phone |
9910433111 |
| Fax |
|
| Email |
daxabraham.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Karina |
| Designation |
Post graduate student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room Number-QS27, 2nd Floor, Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS, Sector 43, Delhi, Surajkund-Badkal Road
Faridabad
HARYANA
121004
India |
| Phone |
7042676757 |
| Fax |
|
| Email |
karinasingal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, Faridabad |
|
|
Primary Sponsor
|
| Name |
Karina |
| Address |
Room Number-QS27, 2nd Floor, Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS, Sector 43, Delhi, Surajkund-Badkal Road |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Karina |
Manav Rachna Dental College |
Room Number QS27, 2nd Floor, Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faculty of Dental Sciences, MRIIRS, Sector 43, Delhi, Surajkund Badkal Road
Faridabad
HARYANA |
7042676757
karinasingal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy controls |
healthy individuals with no evidence of caries and systemic disease |
| Intervention |
Root Canal Treatment |
Non surgical root canal treatment in maxillary and mandibular molars.
The levels of the biomarker NLRP3 shall be evaluated before and one week after completion of endodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with pulp necrosis and symptomatic apical periodontitis in a single tooth as per the clinical and pulp sensibility tests (according to the AAE guidelines)
2. Patients aged 18-40 years of age
3. Patients with no relevant medical history or absence of any systemic conditions
4. Non-smokers |
|
| ExclusionCriteria |
| Details |
1. Patients with periodontitis
2.Patients with multiple carious teeth
3. Patients with apical abscess (swelling) &/or sinus tract |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The NLRP3 levels in GCF may be increased and hence detectable in patients with Pulp Necrosis and Symptomatic Apical Periodontitis but will reduce after endodontic treatment |
One week after completion of endodontic treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="15" |
|
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
|
Patient’s consent will be obtained. Group 1 will constitute healthy individuals with no evidence of caries and systemic disease. Group 2 will constitute patient diagnosed with pulpal necrosis and symptomatic apical periodontitis (systemically healthy). 1. All subject will be diagnosed by using the standard and prescribed diagnostic tests and detailed medical history will be taken devoid of any systemic diseases. 2. The patient will be asked to get a consent form from a physician indicating that the results of both their blood and urine reports are normal to rule out any systemic condition of a patient. 3. Patient’s case history, oral examinations, oral health index will be carried out using artificial light, mouth mirror, and explorer. Pulp sensibility test will be carried out. Before the commencement of the study, the subject will receive detailed information about the study and written consent will be obtained. 4. Patient will be advised to get oral prophylaxis done by a dental surgeon one week prior to GCF collection in order to proceed for further steps. Patient will be asked to perform regular oral hygiene procedures. 5. Prevent them from eating and drinking 1 hour prior to sample collection. Using the capillary method 10 microliters capillary tube gently tapped near the involved tooth till the desired volume of GCF will be obtained through capillary action. 6. The sample will then transferred to an Eppendorf tube using air pressure till it will be collected at the bottom of the Eppendorf tube. 7. The tubes will be carefully sealed and stored at a temperature of -80 degree Celsius until the ELISA tests will be conducted. 8. Using similar method samples will be collected from the adjacent and the contralateral teeth and also from the caries-free individuals in the healthy group. 9. Samples that will be contaminated with blood and saliva will be discarded and would be reassessed or another sample will be chosen followed by endodontic treatment. 10. GCF sample will be collected 1 week after the completion endodontic treatment and ELISA test will be conducted.
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