| CTRI Number |
CTRI/2024/10/074560 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of coronal flaring on the working length in mandibular molars |
|
Scientific Title of Study
|
Effect of coronal flaring on the working length of mesial root canals of mandibular molars using different orifice openers- 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 |
Khushi Patel |
| Designation |
PG Student |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9904070787 |
| Fax |
|
| Email |
khushipatel1901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Shah |
| Designation |
Professor and PG Guide |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376121229 |
| Fax |
|
| Email |
drshah16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Patel |
| Designation |
PG Student |
| Affiliation |
College of Dental Sciences and Research Centre |
| Address |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT
380058
India |
| Phone |
9904070787 |
| Fax |
|
| Email |
khushipatel1901@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 7,Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre,Manipur,Ahmedabad,380058,India |
|
|
Primary Sponsor
|
| Name |
Khushi Patel |
| Address |
Room no 7,Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre,Manipur,Ahmedabad,380058,India |
| 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 Khushi Patel |
College of Dental Sciences and Research Centre |
Room no. 7, Department of Conservative Dentistry and Endodontics,College of Dental Sciences and Research Centre, Manipur,Ghuma,Ahmedabad
Ahmadabad
GUJARAT |
9904070787
khushipatel1901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, College of Dental Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hylflex CM orifice opener |
Orifice opener which is heat treated with a taper of 8 % and 19mm length and used till 5mm of length reached |
| Comparator Agent |
Neoendo flex orifice opener |
Orifice opener with 8% taper and 19mm length and used till 5mm of length reached |
| Comparator Agent |
Rotary orifice opener |
Orifice opener with 8% taper and 19mm length and used till 5mm of length is reached |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Permanent mandibular molars having mesial roots with two(MB and ML) separate canals
Teeth with mesial root curvature of more than 25 degrees (Schneider’s Technique)
Teeth with intact mature apices
|
|
| ExclusionCriteria |
| Details |
Teeth with cracks , resorption and calcification
Teeth with restorations or previously treated teeth
Fractured teeth
Teeth with root caries
Teeth with fused mesial and distal roots or single mesial canal in mesial roots
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in working length before and after coronal flaring |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in working length with different orifice openers |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/10/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The long term success of the root canal treatment will improve if there is no change in working length before and after coronal flaring and with different orifice openers Comparing the different orifice openers, will provide us with the one which would help in preserving the maximum cervical dentin thickness , hence minimum cutting. |