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CTRI Number  CTRI/2024/06/068673 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pulp therapy of milk teeth with new rotary instruments. 
Scientific Title of Study   Comparative efficacy of two rotary single file systems in pulpectomy of primary molars- A randomized 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 Minakshi Gogne 
Designation  PG Student 
Affiliation  SGT Dental College Hospital and Research Institute 
Address  Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  9654995089  
Fax    
Email  minakshigogne@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Anil Gupta 
Designation  HOD and Professor 
Affiliation  SGT University 
Address  Department of Pediatric and Preventive Dentistry,Faculty of Dental Sciences, SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  9899039805  
Fax    
Email  anil.gupta@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Minakshi Gogne 
Designation  PG Student 
Affiliation  SGT Dental College Hospital and Research Institute 
Address  Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana

Gurgaon
HARYANA
122505
India 
Phone  9654995089  
Fax    
Email  minakshigogne@yahoo.com  
 
Source of Monetary or Material Support  
SGT Dental College Hospital and Research Institute Hospital SGT University Budhera Gurugram Haryana 122505 
 
Primary Sponsor  
Name  SGT University Gurugram Haryana 
Address  Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT Dental College Hospital and Research Institute SGT University Budhera Gurugram Haryana 122505 India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Minakshi Gogne  SGT Dental College Hospital and Research Institute Hospital Gurugram Haryana  Room no 6 Department of Pediatric and Preventive Dentistry Faculty of Dental Sciences SGT Dental College Hospital and Research Institute Hospital SGT University Budhera Gurugram Haryana
Gurgaon
HARYANA 
9654995089

minakshigogne@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee -SGT Dental College Hospital and Research Institute(IEC-SGTDCHRI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kedo Nano Plus(Sixth generation)  Pulpectomy of primary molars will be done by using Kedo Nano Plus rotary single file system. 
Comparator Agent  Kedo-S Plus(Fifth generation)  Pulpectomy of primary molars will be done by using Kedo-S Plus rotary single file system. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Children Aged 3-9 years
2. Primary molars which are indicated for pulpectomy procedure.
3. Minimum 2/3 rd of root length remaining.
4. Teeth must be restorable.
5. Single visit pulpectomy.
 
 
ExclusionCriteria 
Details  1. Pulpal floor perforation
2. Excess tooth mobility or tooth near exfoliation stage
3. Teeth with internal or external resorption
4. Excessive root resorption involving more than half of root length
5. Teeth with sinus tract or abscess
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of time taken and quality of obturation for instrumentation between two types of rotary systems ,Kedo S Plus and Kedo Nano Plus.
 
Radiographic and clinical records will be taken at baseline, postoperative, 3 months,6 months and 12 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical & radiographic success of pulpectomy procedure.  Evaluation of clinical & radiographic success will be done at 6 months & 12 months. 
 
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   N/A 
Date of First Enrollment (India)   21/06/2024 
Date of Study Completion (India) 11/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Publication in process 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 

Pulpectomy has emerged as the preferred treatment modality over extraction, for primary teeth with irreversible pulpitis .While hand files have served as the traditional method for paediatric endodontics, rotary instruments offer advancements that can significantly impact treatment in terms of limited chair time thereby lesser operator fatigue, lesser risk of iatrogenic errors (like ledges, zipping canal perforations, etc ) improved canal shaping, reduced post operative pain . Owing to the shape memory and super elasticity of Nickel Titanium(NiTi) rotary files, the challenges faced during biomechanical preparation (BMP) of primary root canals, due to their complex tooth morphology, can now be addressed more effectively. The success of primary tooth pulpectomy relies on instrumentation technique. Recent research shows pediatric rotary systems can substantially shorten pulpectomy procedures. Consequently, rotary systems have contributed to the positive management of child behavior and acceptance towards such a complex and demanding procedure.  Studies have also claimed that uniform BMP by pediatric  NiTi rotary files has decreased  post endodontic pain. The recent shift in paediatric endodontics from sequential multifile rotary systems to single-file systems has facilitated the implementation of single-visit pulpectomy procedures. This innovation is associated with improved obturation quality and enhanced treatment efficiency as measured by reduced operative time. One such file system is the Rotary KEDO-S File System which has been developed exclusively for pulpectomy of primary teeth. This rotary system has evolved over 6 generations The objective of our study is to compare KEDO-S PLUS (fifth generation) and KEDO NANO PLUS(sixth generation) rotary files systems. The KEDO-S PLUS instrument facilitates conservative canal shaping and minimizes the risk of iatrogenic apical perforation during root canal preparation. The most recent rotary single file system is the KEDO NANO PLUS (sixth generation). This heat treated single rotary file with nano carbon coating has a  unique variably variable (VV) taper design which makes it a cutting edge rotary single file system. While many comparative studies have evaluated different paediatric rotary systems with manual K files, none of the studies have compared the efficacy of two different rotary single file systems till date. Also, parental attitudes towards dental procedures influence the behavior of the child undergoing dental treatment. Thus, the aim of our study is to evaluate the instrumentation time, quality of obturation and post-operative pain using two different single rotary file systems. We also aim to evaluate the association between parental anxiety and the child’s behavior during the pulpectomy procedure.


 
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