| CTRI Number |
CTRI/2025/02/081135 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare the effect of three different intracanal medicaments on occurence of Pain and Swelling in patients undergoing Root Canal Treatment |
|
Scientific Title of Study
|
To compare the influence of three different intracanal medicaments on
incidence of Interappointment Flare-ups in patients undergoing Root canal treatment – 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 |
Dr Dhruvi Doshi |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
S P Sahakar Vidyadham Ambaji Gandhinagar Link Road
Room Number 5 Department Of Conservative Dentistry And Endodontics
Narsinhbhai Patel Dental College And Hospital Sankalchand Patel University
Mahesana
GUJARAT
382440
India |
| Phone |
8140732535 |
| Fax |
|
| Email |
dhruvidoshi786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital sankalchand patel university visnagar mehasana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental College And Hospital |
| Address |
Room No 5 Department of conservative dentistry and endodontics
Narsinhbhai patel dental college and hospital sankalchand patel university visnagar mehasana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics Narsinhbhai Patel Dental College and Hospital Visnagar Gujarat India 384315 |
|
|
Primary Sponsor
|
| Name |
Dr Dhruvi Doshi |
| Address |
A 3 Vrajvihar Bunglows Opp Pavancity D P Road Modasa Gujarat India 383315 |
| 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 Dhruvi Doshi |
Narsinhbhai Patel Dental Colege And Hospital |
Room No 5 Department of Conservative Dentistry and Endodontics SPU Campus Visnagar
Mahesana
GUJARAT |
8140732535
dhruvidoshi786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No medicament |
To evaluate the incidence of interappointment flareups among the control group and medicament groups |
| Intervention |
Three different intracanal medicament |
To evaluate the incidence of interappointment flareups with placement of Propolis Modified Triple Antibiotic Paste and Bio C Temp intracanal medicament |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Non vital single rooted anteriors and premolars
No response on cold and electric pulp testing |
|
| ExclusionCriteria |
| Details |
Teeth with acute pulpal or periapical lesion
Patients with swelling and sinus tract
Teeth with cracks severe curvature calcification and immature apex
Pregnant and lactating women
patient requiring analgesics and antibiotics
Patient having allergy to honey and honey containing product
Patient having painful condition of more than one tooth ipsilaterally |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interappointment flareups would be lesser with placement of intracanal medicament |
It would be checked at first second third seventh day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of interappointment flareups would be lesser with triple antibiotic intracanal medicament placement |
It would be checked at first second third seventh day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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
|
Total sixty sample will be participating and will be divided into four groups Group A No intracanal medicament will be placed Group B Propolis intracanal medicament will be placed Group C Modified triple antibiotic intracanal medicament will be placed Group D Bio C Temp intracanal medicament will be placed |