| CTRI Number |
CTRI/2025/03/083116 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Instrumentation Time, Quality of Obturation and Postoperative Pain Between Two Single File Systems in Root Canal Treatment of Primary Mandibular Molars |
|
Scientific Title of Study
|
Comparative Evaluation Of Instrumentation Time, Quality Of Obturation And Postoperative Pain Using Two Different Single File Systems In Root Canal Preparation Of Primary Mandibular Molars: A Split Mouth Randomized 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 Isra Gulzar |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9667720906 |
| Fax |
|
| Email |
isra.mds24@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Prof & Head Department of Paediatric and Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Prof & Head Department of Paediatric and Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital and Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre 47, Knowledge Park-III Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Hospital and Research Centre, 47 Knowledge Park-III, Greater Noida, Uttar Pradesh, India PIN-201310 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre Greater Noida |
| Address |
Room Number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre 47, Knowledge Park-III Greater Noida, Uttar Pradesh, India PIN-201310 |
| 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 Isra Gulzar |
ITS Dental College Hospital and Research Centre, Greater Noida |
Room number 9, Department of Paediatric and Preventive Dentistry, ITS Dental College, Hospital and Research Centre 47, Knowledge Park-III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9667720906
isra.mds24@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental College, Hospital and Research Centre Institutional Ethics Committee |
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 |
| Comparator Agent |
Kedo Nano Plus Rotary Single File System |
Rotary Single File System For Root Canal Preparation |
| Comparator Agent |
WaveOne Gold Reciprocating Single File System |
Reciprocating Single File System For Root Canal Preparation |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1- Children in the age group of 4- 8 years
2- Bilateral Involvement of Primary mandibular molars with irreversible pulpitis
3- Teeth with 2/3rd Root length remaining
4- Children free from systemic disease
5- Children with Frankel behaviour rating of 3 and 4
6- Patients who give consent to participate in the research.
|
|
| ExclusionCriteria |
| Details |
1- Teeth close to exfoliation
2- Teeth with mobility
3- Patient present with Extraoral Swelling and Cellulitis
4- Children with special health care needs
5- Teeth with unrestorable crown structure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Instrumentation Time will be recorded using a stopwatch, Post operative radiograph to assess the quality of obturation will be done Using KEDOO Classification |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative Pain Will be checked using the Wong Baker FACES Pain Rating Scale after the Root Canal Treatment in Primary Mandibular Molars has been completed |
6 Hours, 24 Hours & 72 Hours |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="1"
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
|
Dental caries involving the pulp leads to irreversible pulpal inflammation, abscess formation or pulpal necrosis. In such cases Pulpectomy is the treatment of choice. This procedure addresses the issue by removing the infected pulp, followed by cleaning, shaping and drying the root canals and then filling them with a biocompatible material. Hand files are conventionally used for chemo-mechanical preparation during pulpectomy procedures. However, their use can be challenging in the narrow and curved canals of primary teeth that are undergoing physiological resorption, which may result in difficulty to achieve proper filling of the canals and also prolong the treatment duration. Patient cooperation is crucial for the success of paediatric endodontic treatment, as longer procedures can increase anxiety and uncooperative behaviour, negatively affecting treatment quality. Postoperative pain and swelling are common complications of pulpectomy, often caused by apical extrusion of obturating material. To address these challenges, NiTi rotary technique for primary teeth was introduced. Reciprocating movement for canal shaping and debridement has gained popularity in paediatric dentistry due to its improved speed, safety, and fewer errors compared to continuous rotation systems. The Kedo Nano Plus Rotary single file system, features a nanoparticle coating which offers enhanced flexibility and better resistance to torsional forces in curved canals, reducing the risk of file fractures. The newly introduced KEDOO classification divides mandibular molar canals into mesial and distal sections with each canal being assessed individually. Therefore this research aims to evaluate the efficiency of using Kedo Nano Plus rotary single file system and WaveOne Gold reciprocating single file system in root canal preparation of primary mandibular molars in the terms of Instrumentation time, Quality of obturation and postoperative pain. |