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CTRI Number  CTRI/2024/11/077079 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing efficacy of pediatric hand protaper and rotary file. 
Scientific Title of Study   Comparative assessment of quality of obturation and instrumentation time using pediatric hand protaper and pediatric rotary file in primary mandibular molars: an in vivo study 
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 Sachin Parmar 
Designation  PG STUDENT 
Affiliation  Government College of Dentistry, Indore 
Address  Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India

Indore
MADHYA PRADESH
452001
India 
Phone  7415606931  
Fax    
Email  drsachinparmar96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuradha Agrawal 
Designation  Associate Professor 
Affiliation  Government College of Dentistry, Indore 
Address  Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India

Indore
MADHYA PRADESH
452001
India 
Phone  9826436460  
Fax    
Email  anupiyush1@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Parmar 
Designation  PG STUDENT 
Affiliation  Government College of Dentistry, Indore 
Address  Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt College of Dentistry, Sardar Patel Marg, opposite MY hospital, Indore, MADHYA PRADESH, 452001, India

Indore
MADHYA PRADESH
452001
India 
Phone  7415606931  
Fax    
Email  drsachinparmar96@gmail.com  
 
Source of Monetary or Material Support  
Government college of dentistry, indore 
 
Primary Sponsor  
Name  Dr Sachin Parmar 
Address  Room no. 18, Dept of Pediatric and Preventive Dentistry, Govt. College of Dentistry, Sardar Patel Marg, opposite MY hospital MADHYA PRADESH, 452001, India 
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 Sachin Parmar  Govt College of Dentistry  Room no 18, Dept of pediatric and preventive dentistry, Opp M Y hospital, sardar patel marg, indore, 452001
Indore
MADHYA PRADESH 
07415606931

drsachinparmar96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government College of Dentistry, Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No systemic condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kedo-S Square rotary file  Group 2- Twenty teeth underwent instrumentation with the Kedo-S Square rotary file system. Initially, canal preparation involved a size 20 K file, followed by the use of Kedo-S ‘Square’ rotary files (P1) connected to an Endodontic motor (WOODPECKER®, ENDO RADAR) operating at 300 rpm and 2.2 N/cm torque.  
Intervention  Kedo-SH hand protaper  After thorough clinical examination, a standardized periapical radiograph (RVG) was obtained using paralleling angle technique for mandibular primary molar tooth undergoing single visit pulpectomy. To ensure precise radiographs, the Rinn XCP instrument (Dentsply Rinn, Elgin) was utilized in conjunction with radiographic parallelism and a standardized exposure technique, facilitating optimal visualization of the tooth structure and consistent reproducibility. Single visit pulpectomy was performed after randomly allocation of study group. Topical anesthesia was meticulously administered to each selected tooth with Benzocaine 20% gel (Lidayn, ORASPOT; Global Dent Aids Pvt. Ltd.). Subsequent anesthesia for inferior alveolar nerve block (IANB) was achieved by 2% lignocaine with 1:80,000 adrenaline local anesthetic solution (LIGNOX® 2% A, INDOCO REMEDIES Ltd.), Subjective and objective signs of successful anesthesia were evaluated. (Figures 5a and 5b) Subseq4uently, isolation was achieved with a rubber dam (Zodenta, German Stainless CE Rubber Dam Kit). Caries excavation was done using spoon excavator (API®#2980) and the access cavity was prepared using a round bur (BR 41, MANI) in a high-speed handpiece (NSK, PanaAir FX). Subsequently, the pulp chamber was uncovered using a sterile Pear-shaped bur (No. 330, Mani) and irrigated with Normal Saline (Bios, Biosynergy Lifecare Pvt Ltd. India) to eliminate dentinal debris. Coronal pulp amputation was performed with a round bur (BR 41, MANI), and any residual pulp tissue was excavated using a sterile spoon excavator (API® #2980). DG 16 explorer (API®) was used to locate the root canal orifice followed by finishing the access cavity Canal patency was checked radiographically by inserting precurved No.10 K file (18mm, Mani). A diagnostic radiograph was taken with an endodontic file (K file, no.10, 18mm, Mani) placed in each canal to determine the root canal length, with the working length maintained 1 mm shy of the radiographic apex following Ingles method. For biomechanical preparation of root canal, different file systems were used as per the selected study group- GROUP 1: Twenty teeth were prepared using Kedo SH pediatric hand files (Reeganz Dental Care Pvt. Ltd. India) following the manufacturer’s guidelines. The P1 file was employed initially for establishing patency in the molar canals, P2 was used for pulp extirpation, D1 for shaping narrower canals, and E1 for shaping wider canals.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children with the age of 4-8 years old in good general health.
2.Child able to cooperate.
3.Parent/caregiver for the child have consented.
4.Primary mandibular molars indicated for pulpectomy.
5.At least two-thirds of the residual root length and enough coronal tooth structure preserved.
 
 
ExclusionCriteria 
Details  1.Children with systemic disease.
2.Teeth exhibiting sinus tract formation and pathological root resorption. Insufficient coronal tooth structure.
3.Tooth with physiological mobility.
4.Tooth with dental anomalies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Instrumentation Time and Quality of Obturation  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Obturation   at baseline
and after 1 week followup 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/12/2024 
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="0"
Days="20" 
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  

 The primary aim of Pediatric Dentistry is to preserve both primary and permanent teeth in a functional state to support the development of the stomatognathic system. Primary teeth are precious as they help in maintaining the arch integrity, nutrition, phonation, aesthetic appearance and guide the permanent teeth in eruption. Dental caries is most common childhood disease occur due to improper oral hygiene practice, increase in carbohydrate intake and other deleterious oral habits. Dental caries can progress to involve the pulp. Early involvement of pulp can lead to pulpal and periapical diseases. The primary cause typically stems from microorganisms residing within the affected tooth. Nonetheless, numerous other influences, including bacterial, mechanical, thermal, electrical, and chemical factors, can also impact pulp health. The dental pulp is composed of a loose network of connective tissue containing small blood vessels, nerves, and lymphatic vessels. Cellular elements within the pulp include odontoblasts, fibroblasts, undifferentiated cells, and immune system cells. Like other loose connective tissues, the pulp reacts to environmental changes. However, its distinct features such as the absence of collateral circulation, the presence of dentin-forming odontoblasts, and its encasement in rigid dentin make its inflammatory reaction unlike that of any other organ in the human body.

Adequate treatment of pulp involved deciduous teeth is the prime service a pediatric dentist can avail for the child patient. Pulp therapy for primary teeth, based on diagnosis can be vital pulp therapies which includes use of protective liners, indirect pulp treatment, direct pulp treatment, pulpotomy and non-vital pulp therapy i.e. pulpectomy. Success of pulpectomy depends upon several factors such as biomechanical preparation, irrigation, disinfection, and obturation. Root canal cleaning and shaping involves eliminating microbes and extracting infected pulp chamber contents while maintaining the root canal’s structural integrity. Different file system have been suggested for primary teeth root canal preparation two of which are used in this study. 

The primary objective of this study is to assess and compare the significant difference in instrumentation time and obturation quality between exclusive pediatric hand protaper i.e. Kedo-SH and fourth generation pediatric rotary files i.e. Kedo S Square.

 
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