| CTRI Number |
CTRI/2023/11/060163 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate presence of Pain after single visit root canal treatment in back teeth region using two types of files and to check the breakage of files |
|
Scientific Title of Study
|
Comparison of Post operative pain and fracture resistance of rotary and reciprocating files treated in Molar teeth |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajay Krishna S |
| Designation |
MDS First Year |
| Affiliation |
CSI college of Dental Sciences and Research |
| Address |
CSI college of Dental Sciences and Research,Department Of Conservative Dentistry and Endodontics,Room Number 6,129 CMH compound,old kuvayarpalayam Road,East Veli street,Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9092223778 |
| Fax |
|
| Email |
ajayjaya2551998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay Krishna S |
| Designation |
MDS First Year |
| Affiliation |
CSI college of Dental Sciences and Research |
| Address |
CSI college of Dental Sciences and Research,Department Of Conservative Dentistry and Endodontics,Room Number 6,129 CMH compound,old kuvayarpalayam Road,East Veli street,Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9092223778 |
| Fax |
|
| Email |
ajayjaya2551998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
Professor and Head Of The Department |
| Affiliation |
CSI college of Dental Sciences and Research |
| Address |
Department Of Conservative Dentistry and Endodontics,Room Number 6,129 CMH compound,old kuvayarpalayam Road,East Veli street,Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajay krishna S |
| Address |
Room No 6 129,CMH Compound,Old Kuvayarpalayam Road,East Veli Street,Madurai |
| 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 |
| DrAjay krishna s |
CSI college of Dental Sciences and Research |
Department of Conservative
Dentistry and
Endodontics,Room No 6,129 CMH
Compound, East Veli
Street, Madurai,
Tamil nadu 625001
Madurai
TAMIL NADU
Madurai
TAMIL NADU |
9092223778
ajayjaya2551998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AND INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Device: root canal rotary files |
Post operative pain evaluation
using different rotary file system |
| Comparator Agent |
Rotary and reciprocation files |
Evaluation of post operative
pain and fracture resistance between rotary and
reciprocation files |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Maxillary and mandibular molar teeth with radio-graph evidence of decay approximating the pulp |
|
| ExclusionCriteria |
| Details |
Teeth not amenable to post-endodontic restoration
Teeth with periapical radiolucencies, presence of additional roots
or canal variations
Absence of occlusal contact |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluation of Post operative pain using different
rotary and reciprocating instrument followed by testing the fracture resistance of used instrument |
48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing the post operative analgesics intake
among participants |
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/12/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 present clinical evaluation was planned for comparing the post-operative pain incidence in molar teeth with acute irreversible pulpitis treated by rotary and
reciprocation files in single-visit root canal treatment and to test the fracture resistance of files used for treatment
|