| CTRI Number |
CTRI/2024/05/066831 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain Assessment during and after Non-surgical Root Canal Treatment using XP-Endo Shaper Plus Sequence and Trunatomy Rotary Endodontic File: A Randomised Controlled Trial |
|
Scientific Title of Study
|
Per-operative and post-operative pain assessment after using XP-Endo Shaper Plus Sequence and Trunatomy rotary endodontic file for non-surgical root canal treatment: A randomised controlled 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 |
Suhina Roy Chowdhury |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,
2nd floor,
Guru Nanak Institute of Dental Sciences and Research,
157/F, Nilgunj Road, Sahid Colony, Panihati
Kolkata
WEST BENGAL
700114
India |
| Phone |
8420398205 |
| Fax |
|
| Email |
suhinaroychowdhury@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Paromita Mazumdar |
| Designation |
Head of the Department |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,
2nd floor,
Guru Nanak Institute of Dental Sciences and Research,
157/F, Nilgunj Road, Sahid Colony, Panihati,
Kolkata
Kolkata
WEST BENGAL
700114
India |
| Phone |
9831029606 |
| Fax |
|
| Email |
head_cons.gnidsr@jisgroup.org |
|
Details of Contact Person
Public Query
|
| Name |
Suhina Roy Chowdhury |
| Designation |
MDS Post Graduate Trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics,
2nd floor,
Guru Nanak Institute of Dental Sciences and Research,
157/F, Nilgunj Road, Sahid Colony, Panihati,
Kolkata
WEST BENGAL
700114
India |
| Phone |
8420398205 |
| Fax |
|
| Email |
suhinaroychowdhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute of Dental Sciences and Research,
157/F, Nilgunj Road, Sahid Colony, Panihati,
Kolkata- 700114 |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
157/F, Nilgunj Road, Sahid Colony, Panihati,
Kolkata- 700114
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 Suhina Roy Chowdhury |
Guru Nanak Institute of Dental Sciences and Research |
Department of Conservative Dentistry and Endodontics,
2nd floor,
PG Division,
157/F, Nilgunj Road, Sahid Colony, Panihati,
Kolkata-700114
Kolkata
WEST BENGAL |
8420398205
suhinaroychowdhury@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Trunatomy endodontic file system |
Speed: 500 rpm
Torque: 1.5Ncm
Frequency: 2-3 gentle strokes of 2-5 mm motions
Route of administration: Intracanal
Duration: 2 minutes |
| Intervention |
XP-Endo Shaper Plus Sequence Endodontic File |
Speed: 800 rpm
Torque: 1 Ncm
Frequency: 4-5 strokes
Route of administration: Intracanal
Duration: 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient without any systemic disease
2. Teeth with fully formed mature roots
3. Patient diagnosed with Symptomatic Irreversible Pulpitis in single rooted premolars
4. Teeth with canal curvature less than 30 degree
5. Teeth which are not tender on percussion
6. Teeth without any periapical lesion |
|
| ExclusionCriteria |
| Details |
1. Patient with uncontrolled systemic disease, co-morbidities
2. Patient with known allergies to local anaesthesia, sodium hypochlorite, analgesics
3. Pregnant and lactating patient
4. Patient with a history of medication (analgesic, antibiotic) 15 days before operation
5. Teeth with multiple roots, complex root canal anatomy, calcified canals
6. Teeth with root caries
7. Non-vital teeth
8. Case of previous endodontic treatment
9. Teeth with immature/open apex
10. Teeth showing root resorption
11. Teeth with periapical radiolucent lesion, sinus tract, abscess, facial cellulitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of pain following root canal instrumentation using XP-Endo Shaper Plus File
2. Incidence of pain following root canal instrumentation using TruNatomy file system
3. Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file system |
Pain will be assessed at following time intervals- immediately after biomechanical preparation, 24 hours, 3 days, 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative evaluation of pain experienced following root canal instrumentation using XP-Endo Shaper Plus and TruNatomy file system |
Immediately after BMP, 24 HOURS, 3 days, 7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
08/01/2025 |
| Date of First Enrollment (Global) |
15/05/2024 |
| Date of Study Completion (Global) |
08/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
AIM OF THE STUDY: To evaluate and compare incidence of pain during and after non-surgical endodontic treatment of teeth with symptomatic irreversible pulpitis using XP-Endo shaper plus and TruNatomy file system MATERIALS AND METHODS: The study is designed as a prospective, randomized, double blinded, clinical trial. 40 patients will be enrolled from the Department of Conservative Dentistry and Endodontics who are systemically healthy between 15-40 years of age and fulfilling the inclusion criteria of the study. Patient will be randomly assigned into two equal groups using Simple Random Sampling by rolling a dice. Odd number will be assigned to Group 1 (1,3,5) and even number will be assigned to Group 2 (2,4,6). Group 1: Instrumentation using XP-Endo Shaper plus sequence Group 2: Instrumentation using Trunatomy file sequence Patient and outcome assessor will be blinded to the groups of the study. The randomized order of instrumentation procedure will be enclosed in sealed, opaque envelopes. Treatment will be carried out in 2 visits. In first visit, root canal treatment will be performed upto biomechanical preparation. In group 1, instrumentation will be done with XP-Endo shaper plus and in group 2, instrumentation will be done with Trunatomy file system. In the 2nd visit, obturation will be done. Each of the 40 patients, will be taught how to use VAS scale. On a scale of 1-10, the patient will be asked to rate their pain. Pain will be evaluated at following time intervals: immediately after BMP, 24 hours, 3 days, 7 days. |