| CTRI Number |
CTRI/2024/05/067948 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Post operative pain comparison using continuous and reciprocating file systems. |
|
Scientific Title of Study
|
Comparative Evaluation of Post-Operative Pain using
Continuous and Reciprocating Motion Rotary File Systems - A
Clinical Trial |
| 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 Sonal Mukhraiya |
| Designation |
MDS (Postgraduate) |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room NO 7
Department of Conservative Dentistry and Endodontics
ITS Dental College Hospital and Research Centre
Gautam Buddha Nagar
Uttar Pradesh
201310
India
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9149378269 |
| Fax |
|
| Email |
mukhraiyasonal01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room no 7
Department of Conservative Dentistry and Endodontics
ITS Dental College, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room no 7
Department of Conservative Dentistry and Endodontics
ITS Dental College, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College Hospital and Research Centre, Knowledge Park III, Greater Noida, Uttar Pradesh- 201310, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
Room No 7
Department of Conservative Dentistry and Endodontics
ITS Dental College
Greater Noida
Uttar Pradesh-201310
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sonal Mukhraiya |
ITS Dental College Hospital and Research Centre, Greater Noida |
Room No 7
Department of Conservative Dentistry and Endodontics
I.T.S Dental College Hospital and Research Centre
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
09149378269
mukhraiyasonal01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital and Research Centre Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
People Requiring Intentional Root Canal Treatment for the fabrication of Crown and Bridge |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand ProTaper Files |
Dentsply hand ProTaper Files will be used for the intentional root canal treatment. |
| Intervention |
Neo- endo reciprocation file. |
These files will be used in reciprocating motion 150 degrees counter-clockwise and 30 degrees in clockwise direction. It has S shaped cross section. Speed is 350 rpm and torque is 1.5-2 Ncm |
| Intervention |
ONE Reci reciprocation rotary files. |
These files will be used in reciprocating motion. They have a patented asymmetric cross section. They are made by C- wire heat treatment. It is used in 170 degrees counter- clockwise and 60 degrees clockwise direction. The speed is 300-400 rpm and maximum torque is 4 Ncm. |
| Intervention |
ProTaper Next rotary files |
These files will be used in continuous motion. THey have off-centered cross section. The speed is 300 rpm and torque is between 4-5.2 Ncm. |
| Intervention |
TruNatomy rotary files. |
These files will be used in continuous motion. They have off-centered cross section. Speed is 500 rpm and torque is 1.5 Ncm. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital teeth indicated for intentional RCT.
2. Age group- 20-50 years.
1. Single or multi rooted teeth (radiographically and clinically assessed).
2. Patients with completely formed roots(mature apex).
3. Teeth with only Vertucci Type 1 root canal morphology. Patients consenting to be a part of this study:
5. Medically fit patients (i.e no general
disease or pregnancy). |
|
| ExclusionCriteria |
| Details |
1. Teeth with wide or open apex
2. Non vital teeth.
3. Endodontic retreatment cases.
4. Third molars
5. Patients using analgesics, NSAIDs oranxiolytics during 7 days before the procedure.
6. Teeth with poor prognosis.
7. Teeth with complex root canal morphology.
8. Patients unwilling to participate in the study
9. Patients with active pain in any tooth.
10. Pregnant patients and nursing mothers. Presence of systemic diseases such as cardiovascular disease, renal disease and any bleeding disorders.
11. Patients with sinus tract, periapical abscess or facial cellulitis, known allergies or any contraindication to opioid or non-opioid analgesics including aspirin or NSAIDs.
12. Patients with known allergy to local anesthesia, sodium hypochlorite and chlorhexidine.
13. Presence of systemic diseases such as cardiovascular
disease,diabetes mellitus, renal disease and any bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate continuous and reciprocating motion rotary file systems for the incidence of post operative pain. |
Patients will be asked to record the pain at 8 hrs, 24 hrs, 48 hrs and 72 hrs using NRS Scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify a rotary fie system that minimizes the incidence of post operative pain. |
Pain will be recorded at 8 hrs, 24 hrs, 48 hrs and 72 hrs using NRS Scale. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is being done to comparatively evaluate post operative pain using ProTaper Next and TruNatomy rotary files in continuous motion and One RECI and Neo-endo reciprocation files in reciprocating motion. This clinical study will be conducted in the Department of Conservative Dentistry and Endodontics, I.T.S. Dental College, Hospital and Research Centre, Greater Noida (U.P). A total number of 100 patients reporting to the O.P.D. of Department of Conservative Dentistry and Endodontics will be selected according to the inclusion and exclusion criteria. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. 100 patients will be randomly allocated into 5 groups of 20 patients each :- Group 1(n=20): Control group (Hand ProTaper), Group 2(n=20): ProTaper Next rotary file, Group 3(n=20): TruNatomy rotary file, Group 4(n= 20): One RECI reciprocating rotary file, Group 5(n=20): Neo-endo reciprocation file. No intracanal medicament will be placed in all the patients. Post operative pain will be recorded after biomechanical preparation at baseline 8 hours, 24hours, 48 hours and 72 hours telephonically using NRS scale. Thereafter, the patients will be recalled for oburation. |