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CTRI Number  CTRI/2025/08/092913 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing the time taken and pain after using different file techniques (hand, rotary, and special rotary) for cleaning primary molar teeth in children aged 6 to 8 years  
Scientific Title of Study   Comparative evaluation of the instrumentation time and post-operative pain of hand file, rotary file and controlled memory rotary file techniques in biomechanical preparation of primary molars: A randomized controlled 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  Nikita Kishor Jakhotiya 
Designation  Post graduate student 
Affiliation  Pacific Dental College And Hospital  
Address  Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital Debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India

Udaipur
RAJASTHAN
313024
India 
Phone  7588718610  
Fax    
Email  nikitajakhotiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao 
Designation  HOD Pg guide 
Affiliation  Pacific Dental College And Hospital  
Address  Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital Debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India

Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Nikita Kishor Jakhotiya 
Designation  Post graduate student 
Affiliation  Pacific Dental College And Hospital  
Address  Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India

Udaipur
RAJASTHAN
313024
India 
Phone  7588718610  
Fax    
Email  nikitajakhotiya@gmail.com  
 
Source of Monetary or Material Support  
Pacific Dental College And Hospital Debari Udaipur 313024 
 
Primary Sponsor  
Name  Nikita Kishor Jakhotiya 
Address  Pacific Dental College And Hospital Debari Udaipur 313024 
Type of Sponsor  Other [[Self]] 
 
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 Nikita Kishor Jakhotiya  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024 Udaipur RAJASTHAN
Udaipur
RAJASTHAN 
7588718610

nikitajakhotiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A409||Streptococcal sepsis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Controlled memory rotary files  Cleaning and shaping of primary molars using controlled memory rotary files (CM rotary system). Pre-instrumentation with K-file followed by CM rotary files using 300rpm and 2.4 Ncm torque. 
Comparator Agent  Hand Files  It will be used for cleaning and shaping of primary molars using hand file. Manual instrumentation will be done using NiTi K-Flex files (15–35),and irrigation with NaOCl and saline irrigation and EDTA lubrication. 
Intervention  Rotary files  Cleaning and shaping of primary molars will be done using rotary files (conventional NiTi rotary system). Utilization of pediatric rotary files, for biomechanical preparation of primary molars. Pre instrumentation of the canals will be done using no. 15 NiTi-K flex file followed by Kids-e rotary files at 300 rpm and 2.4 Ncm torque. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children aged 6 to 8 years with at least one mandibular primary molar requiring pulpectomy
Primary mandibular molars with asymptomatic irreversible pulpitis with a minimum of two third of root length remaining.
Preoperative radiograph revealing absence of periapical lesion or interradicular radiolucency.
Children who are cooperative and able to sit through treatment procedures.
Parental or guardian consent and child assent obtained for participation in the study.
 
 
ExclusionCriteria 
Details  Patient with any systemic diseases or disabilities or incompetent to understand instructions
Patient with history of taking analgesics 12 hour before and after the pulpectomy procedure.
Teeth with internal or external root resorption extending beyond one-third of the root.
Teeth with pathological mobility or advanced periodontal involvement.
Presence of periapical or furcal radiolucency exceeding 5 mm.
History of acute dental pain or abscess within the past 48 hours.
Teeth previously treated endodontically or with open apex.
Children with a known allergy to local anesthetics or endodontic materials.
Uncooperative behavior making it difficult to complete the procedure under routine clinical settings.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
time of instrumentation and postopertaive pain with rotary and control memory rotary  instrumrntation time and postoperative pain at an interval of 6 24 48 72 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Behavioral response of the child
Postoperative analgesic consumption incidence of intraoperative complications 
instrumentation time postoperative pain analgesic consumption at an interval of 6 24 48 72 hour 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3/ Phase 4 
Date of First Enrollment (India)   23/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/08/2025 
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)   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  

Preservation of primary teeth until their natural exfoliation is a key objective in paediatric dentistry. Primary molars are vital for maintaining arch length, guiding permanent tooth eruption, supporting mastication, and promoting overall oral health. When these teeth are compromised by extensive caries or pulpal pathology, pulpectomy is often the treatment of choice to retain them until natural exfoliation.

Pulpectomy involves the removal of necrotic or irreversibly inflamed pulp tissue, followed by biomechanical preparation, disinfection, and obturation. Among these, biomechanical preparation is crucial for cleaning and shaping the canals and eliminating microbial load. The success of this step is highly influenced by the instrumentation technique used.

Traditionally, stainless steel hand files have been employed for this purpose. While effective, they are time-consuming, technique-sensitive, and often difficult to use in uncooperative paediatric patients due to prolonged chair time. To address these challenges, rotary instrumentation systems which was originally designed for permanent teeth, know have been adapted for use in primary molars. These systems offer advantages such as uniform canal shaping, reduced operator fatigue, and significantly shorter instrumentation time. However, their limited flexibility poses challenges in navigating the narrow, curved canals of primary molars.

Recent innovations like controlled memory (CM) rotary files offer improved flexibility and resistance to cyclic fatigue, allowing safer navigation through complex canal anatomies with less apical debris extrusion. This is particularly important since debris extrusion can lead to post-operative pain, which is a significant factor in a child’s perception of dental treatment.

Despite the increasing adoption of rotary and CM rotary instrumentation in paediatric dentistry, limited clinical trials have directly compared these techniques with conventional hand files in primary molars, particularly focusing on both instrumentation time and post-operative pain. Most available studies are in vitro or observational, underscoring the need for well-designed randomized controlled clinical trials in this area.

This study aims to fill this gap by conducting a randomized controlled clinical trial to evaluate and compare the instrumentation time and post-operative pain associated with hand files, rotary files, and CM rotary files during biomechanical preparation of primary molars in children aged between 8 and 12 years. By assessing both clinical efficiency and patient-centered outcomes, this study seeks to identify the most suitable instrumentation technique for paediatric endodontic practice.

The findings of this study will contribute valuable insights into improving the quality of care, reducing treatment time, enhancing patient comfort, and ultimately supporting better treatment outcomes in paediatric dentistry.

 
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