| CTRI Number |
CTRI/2024/04/066267 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lowering Inflammation And Reducing Post Root Canal Pain: Enlarging Tip Can Help |
|
Scientific Title of Study
|
Effect of Foraminal Enlargement on Postoperative Pain and Inflammatory Markers In Asymptomatic Single-Rooted Mandibular Teeth - An In Vivo 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 |
Pooja Gandhe |
| Designation |
Post Graduate |
| Affiliation |
Malla Reddy Dental College For Women |
| Address |
Room No.: 4, Department Of Conservative Dentistry And Endodontics, Malla Reddy Dental College For Women, Suraram, Hyderabad.
Hyderabad
TELANGANA
500055
India |
| Phone |
8074624851 |
| Fax |
|
| Email |
poojagandhe1702@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Swathi |
| Designation |
Head of the department, Professor |
| Affiliation |
Malla Reddy Dental College For Women |
| Address |
Room No.: 4, Department Of Conservative Dentistry And Endodontics, Malla Reddy Dental College For Women, Suraram, Hyderabad.
Hyderabad
TELANGANA
500055
India |
| Phone |
9866021672 |
| Fax |
|
| Email |
drswathi.endo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Gandhe |
| Designation |
Post Graduate |
| Affiliation |
Malla Reddy Dental College For Women |
| Address |
Room No.: 4, Department Of Conservative Dentistry And Endodontics, Malla Reddy Dental College For Women, Suraram, Hyderabad.
Hyderabad
TELANGANA
500055
India |
| Phone |
8074624851 |
| Fax |
|
| Email |
poojagandhe1702@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malla Reddy Dental College For Women, Suraram, Hyderabad-500055 |
|
|
Primary Sponsor
|
| Name |
G.POOJA |
| Address |
Malla Reddy Dental College For Women, Suraram, Hyderabad - 500055 |
| 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 Pooja Gandhe |
Malla Reddy Dental College For Women |
Room No.: 4, Department Of Conservative Dentistry And Endodontics, Malla Reddy Dental College For Women, Suraram, Hyderabad - 500055
Hyderabad
TELANGANA |
8074624851
poojagandhe1702@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Malla Reddy Dental College For Women, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enlargement Of Apical Foramen |
Enlargement Of Apical Foramen to decrease the microbial load |
| Comparator Agent |
Root canal treatment Without Enlarging apical foramen |
No enlargement of apical foramen |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic patients requiring dental treatment |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions which increase the inflammatory markers |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreasing the microbial load |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention Of Retreatment |
Baseline |
|
|
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 3 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="0"
Months="6"
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
|
Aim of the study: To assess the effect of Apical foraminal enlargement on inflammatory markers and pain in patients with asymptomatic single-rooted mandibular teeth with Apical Periodontitis (AP). Materials and Method: The study will include 60 patients based on inclusion and exclusion criteria. Before beginning root canal treatment, a blood sample will be obtained from the antecubital fossa to evaluate the inflammatory markers, CRP (C-Reactive Protein), and ESR (Erythrocyte Sedimentation Rate). Access opening will be done, and initial irrigation will be done. Working length will be determined with an EAL (Electronic Apex Locator) and will be verified with a radiograph. In the control group, the determined working length will be maintained, while in the experimental group, the working length will be set till the apical foramen. Biomechanical preparation will be done in both groups till F2 or F3 based on the initial apical file, followed by final irrigation and obturation based on the master apical file size. Patients will be given a visual analog scale to record pain sensations at 24, 48, and 72 hours post-operative. After 72 hours, patients will be recalled for follow-up appointments, and blood will be taken from the antecubital fossa again to evaluate inflammatory markers. Statistical Analysis : The obtained data will be subjected to statistical analysis |