FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105495 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 09/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Combined In vitro and In vivo Evaluation of five rotary file systems radiographically and clinically in primary molar teeth. 
Scientific Title of Study   "Clinical and Radiographical Evaluation o f Five Rotary File Systems in Primary Molar Teeth: An In Vivo and In Vitro Study." 
Trial Acronym  Randomised controlled trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Antra Singh 
Designation  PG student 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department number 5, Department of Pediatric and Preventive Dentistry
Raibareli Rd, Utrathia, Vrindavan Colony, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226029
India 
Phone  8173809928  
Fax    
Email  antrav540@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Saha 
Designation  Professor and director 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department number 5, Department of Pediatric and Preventive Dentistry
Raibareli Rd, Utrathia, Vrindavan Colony, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226029
India 
Phone  9889234995  
Fax    
Email  drsonalisaha24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Antra Singh 
Designation  PG student 
Affiliation  Sardar Patel Post Graduate institute of dental and medical sciences 
Address  Department number 5, Department of Pediatric and Preventive Dentistry
Raibareli Rd, Utrathia, Vrindavan Colony, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226029
India 
Phone  8173809928  
Fax    
Email  antrav540@gmail.com  
 
Source of Monetary or Material Support  
Department no 5, Pediatric and Preventive Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Raibareli Rd, Utrathia, Vrindavan Colony, Lucknow, Uttar Pradesh 226029 
 
Primary Sponsor  
Name  Dr Antra Singh 
Address  Department no 5, Pediatric and Preventive Dentistry, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Raibareli Rd, Utrathia, Vrindavan Colony, Lucknow, Uttar Pradesh 226029. 
Type of Sponsor  Private medical college 
 
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 Antra Singh  SARDAR PATEL POST GRADUATE INSTITUE OF DENTAL AND MEDICAL SCIENCES  Department no 5, Department of Paediatric and Preventive Dentistry
Lucknow
UTTAR PRADESH 
8173809928

antrav540@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient requiring pulpectomy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kedo SH hand file  To evaluate the instrumentation time, taper of the canal (clinical evaluation) and the quality of obturation (radiographic evaluation) using Kedo SH hand file system. 
Intervention  The aim of the study is to comparatively evaluate the instrumentation time, taper of the canal clinically and the quality of obturation radiographically following the cleaning and shaping using four different rotary file system and also to evaluate and compare the intracanal 3D shape, debris index and smoothness of the prepared canal using these file systems: A combined In vitro and In vivo study.  To evaluate the instrumentation time, taper of the canal (clinical evaluation) and the quality of obturation (radiographic evaluation) Kedo nano plus rotary file system, Kids e rotary file system, Pedoflex rotary file system and Prime pedo rotary file systems. To compare the instrumentation time, taper of the canal (clinical evaluation) and the quality of obturation (radiographic evaluation) Kedo nano plus rotary file system, Kids e rotary file system, Pedoflex rotary file system and Prime pedo rotary file systems. To compare the 3D shaping (In vitro) of the prepared root canal using Kedo SH hand file, Kedo nano plus rotary file system, Kids e rotary file system, Pedoflex rotary file system and Prime pedo rotary file systems. To evaluate and compare the debris index and smoothness index (In vitro) of the prepared root canal using the Kedo SH hand file, Kedo nano plus rotary file system, Kids e rotary file system, Pedoflex rotary file system and Prime pedo rotary file systems.  
 
Inclusion Criteria  
Age From  4.00 Day(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children between the ages of 4 and 7 who required pulpectomy treatment in any one of their necrotic posterior primary teeth.
Primary molars with at least a 2/3-inch root length
Teeth with adequate crown structure for rubber dam placement
Teeth having persistent and chronic irreversible pulpitis.
Presence of radiolucency in the peri-radicular or furcal region and patients with nocturnal pain.
 
 
ExclusionCriteria 
Details  Patients with a systemic illness.
Patients with clinically unrestorable teeth with perforated pulpal floor.
Teeth having abnormal mobility.
Patients having Extra-oral edema or the existence of a dentoalveolar abscess (presence of purulence in the canals)
Patients that have pathologic root resorption in more than one-third of their roots.
Parents who refused to sign the informed consent form.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The expected outcome of the study may be that out of all the five file systems used (sample size- 105) Kedo nano plus is highly effective clinically and radiographically in cleaning and shaping the root canals of primary teeth as compared to the other file systems used in the study.  2.5months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/03/2026 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
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)  

”Deciduous teeth” comes from the Latin phrase ”decidere,” which means ”to fall out.” Exfoliation occurs when teeth get soft and fall off, replacing them with permanent dentition, similar to how flower petals and leaves do. The most critical issue in pediatric dentistry is the early loss of primary molars that are necrotic due to caries or other factors, including trauma.

Primary teeth plays an indispensable role in the dental and facial development. The dentofacial skeletal complex is adversely affected in terms of soft tissue support, occlusion, full dentition development, and esthetics. Also, the most unpleasant consequence of untreated dental caries in children is pulp involvement.

Over and above, they guide the eruption of permanent teeth . Hence, preserving the primary teeth in its position without any infection is of utmost importance. For the management of necrotic primary teeth, pulpectomy remains as the first choice of treatment.

The main goals of root canal cleaning and shaping are to eradicate bacteria containing soft and hard tissue, create a conduit for irrigation to the apical third, create space for instrumentation, perform future obturation, and maintain the integrity of radicular structures. Therefore, cleaning and contouring the root canals will remove the irrigation pathway, which will ensure the success of the pulpectomy. Reamers, files, burs, sonic tools, mechanical tools, and nickel- titanium (Ni-Ti) rotary file systems are used to prepare root canals.

This endodontic treatment is done to debride the tortuous primary root canals and maintain it in a non- pathologic condition until exfoliation.

Rotary instrumentation has made a quantum leap in the field of endodontics. These changes lead to introduction of rotary endodontics in pediatric dentistry. 

Barr et al. (2000) carried out the first investigation to demonstrate the application of NiTi rotary files in primary molars. The most remarkable feature of using NiTi rotary instruments is that it produced a predefined conical shaped canals with exceptionally reduced instrumentation time.

With fewer appointments, Rotary has increased workability because a child’s behavior is significantly impacted by the length of each appointment.

It was also reported that it would be more effective if pulpectomy in primary tooth is performed with an exclusive paediatric rotary file system with revised length, taper and tip diameter.

Specialized pediatric rotary files with additional modifications, like gold-treated files, heat-treated files with a TiO coating, and files with CM, are now readily accessible for use in primary teeth that have a length from 16 to 18 mm.

Various rotary file systems are available in pediatric dentistry such as: Kedo S, Kedo SG, Kedo SG Blue, Kedo S Square, Pedo Flex, Pro AF Baby Gold, Prime Pedo endo kit.

In 2017, Jeevanandan introduced the Kedo-S rotary file created especially for primary teeth. Kedo-S files comprised five generations which are Kedo-S, Kedo- SG, Kedo-SG blue, Kedo-S-Square, and Kedo-S-Plus. The first generation is made up of three Nickel-titanium (Ni-Ti) files (D1, E1, U1) that have a 12 mm working length and a variable taper to allow effective root canal preparation without over-instrumenting the delicate primary root canal wall. In 2019, a single- file rotary system, Kedo-S-Square file, was invented which consists of two files, A1 for primary anterior teeth & P1 for posterior primary teeth. Kedo-S-Square file has a Ni-Ti heat-treated dual-core with a titanium-oxide coating. Also, it has a unique feature as a variably vari- able taper design and 16 mm working length with a non- cutting tip.

Kids-e-dental has introduced new rotary filing systems, notably the Kids-e-dental rainbow files. To make Kids-e-Files flexible and long-lasting, a nickel-titanium alloy is heat-treated and surface-treated. They can navigate through curved root canals due to their triangular cross section.

ProAF baby comprises five file sequences and is made of heat- treated nickel titanium-controlled memory wire. They maintain a constant taper of 4% and 6% depending on the file sequence used. These files were designed to be similar to the file sequence used for permanent teeth.

The Neoendo flex orifice enlarger measures 19mm in length and has a 8% taper. The use of files with appropriate characteristics such as length, taper, and tip size customized to the root canal morphology of primary teeth is crucial for achieving successful endodontic treatment.

Another paediatric rotary system, the Prime PedoTM, consists of four files: Starter, P1, P2, and Endosonic file. The Prime PedoTM file system includes the Starter file (8% taper, 16 mm), P1 file (#15, 6% taper, 18 mm), P2 file (#25, 6% taper, 18 mm), and endodontic file (2% taper, 18 mm). The length markings on the file are as follows: 12 mm up to the flutes, 13 mm stopper above the flutes, 14 mm marker ring present, and 15 mm above this mark, with a marker ring at 16 mm. As a result, a ruler or scale is not required to align the stopper for repeatedly setting the working length. The Prime PedoTM files have a gold treatment and controlled memory, which allows them to be centered in the curved canals of primary molars.

However, there is paucity in the studies on the comparison of rotary files that are used exclusively for primary teeth. Till date a few clinical trials have been conducted to demonstrate the efficacy of the various pediatric rotary file systems, and hand file systems.

However, there is no comparative study in literature, that have been conducted to evaluate the instrumentation time, taper and quality of obturation using pediatric rotary file systems and modified rotary file systems.

Hence, the present short study will be undertaken to comparatively evaluate the instrumentation time, taper of the canal clinically and the quality of obturation radiographically following the cleaning and shaping using four different rotary file system and also to evaluate and compare the intracanal 3D shape, debris index and smoothness of the prepared canal using these file systems.

Purpose of this research is to comparatively evaluate the instrumentation time, taper of the canal clinically and the quality of obturation radiographically. With an increasing number of clinicians using different rotary systems in primary tooth pulpectomy, it is important to know which rotary system provides the best clinical outcomes for obtaining good- quality obturation.

Therefore, this research will help the clinicians to choose the effective paediatric rotary file system  amongst the five different rotary file systems which will further improve the success rate of the management of the pulpal therapy of the deciduous teeth.

 

 
Close