FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029470 [Registered on: 01/12/2020] Trial Registered Prospectively
Last Modified On: 27/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EVALUATION OF PAIN AFTER SINGLE SITTING ROOT CANAL TREATMENT USING HAND AND ROTARY INSTRUMENTS 
Scientific Title of Study   COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER SINGLE SITTING PULPECTOMY USING HAND AND ROTARY INSTRUMENTATION IN PRIMARY MOLARS OF CHILDREN – A RANDOMISED CONTROL STUDY 
Trial Acronym  PAHRI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nivedita Saxena 
Designation  Post graduate Student 
Affiliation  KLE VK Institute of Dental Sciences. 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI.
KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  6375297559  
Fax    
Email  niveditasaxena40@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivayogi M Hugar 
Designation  Professor and Head 
Affiliation  KLE VK Institute of Dental Sciences. 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI.
KLE VK INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH (KAHER), NEHRU NAGAR,BELAGAVI.
Belgaum
KARNATAKA
590010
India 
Phone  9986436448  
Fax    
Email  dr.hugarsm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nivedita Saxena 
Designation  Post graduate Student 
Affiliation  KLE VK Institute of Dental Sciences. 
Address  Department of Pediatric and Preventive Dentistry, KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research (KAHER), Nehru Nagar, Belagavi.
KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research (KAHER), Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  6375297559  
Fax    
Email  niveditasaxena40@gmail.com  
 
Source of Monetary or Material Support  
KLE VK INSTITUTE OF DENTAL SCIENCES 
 
Primary Sponsor  
Name  Department of Pediatric and Preventive Dentistry 
Address  Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental Sciences, Belagavi. 
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 Nivedita Saxena  Department of Pediatric and Preventive Dentistry  KAHERs KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 
6375297559

niveditasaxena40@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics committee KLE VK Institute of Dental Sciences  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 
Comparator Agent  Manual, K Files  The operator (Principal Investigator) shall perform all the procedures under Standard Operating Protocols. Local anesthesia will be given and rubber dam will be applied. Access cavity preparation will be done using round diamond bur followed by chemo-mechanical instrumentation using K-files in Group A After that obturation will be done by Zinc Oxide Eugenol followed by filing with the suitable restorative material.Patient will be recalled after a week for the placement of Stainless Steel crown. 
Intervention  Pediatric rotary files  The operator (Principal Investigator) shall perform all the procedures under Standard Operating Protocols. Local anesthesia will be given and rubber dam will be applied. Access cavity preparation will be done using round diamond bur followed by chemo-mechanical instrumentation using Pediatric Rotary files in Group B. After that obturation will be done by Zinc Oxide Eugenol followed by filing with the suitable restorative material. Patient will be recalled after a week for the placement of Stainless Steel crown.  
 
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. Children with Frankl’s behaviour rating scale of positive (+) and definitely positive (++).
3. Tooth with the history of spontaneous pain.
4. Radiographic evaluation of the tooth showing irreversible pulpitis.
5. Primary molars with minimum two third of the root length.
6. Patients who are willing to undergo treatment
 
 
ExclusionCriteria 
Details  1. Children with systemic diseases and special health care needs.
2. Non-vital teeth having signs of abscess, sinus and fistula.
3. Primary molars with pathologic mobility and evidence of root fracture, trauma.
4. Primary molars having furcation radiolucency.
5. Primary molars with calcified root canals.
6. Primary molars with more than two third root resorption, internal resorption and developmental anomalies.
7. Patients who are not willing to undergo treatment.
 
 
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 
Post operative pain  24 hours
48 hours
72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in pain, swelling and increasing the quality of life  After 24hours, 48 hours, 72hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2021 
Date of Study Completion (India) 27/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Primary teeth act as a natural space maintainer and guide the eruption of permanent teeth to their optimal position in the dental arch. The retention and preservation of the primary tooth in the dental arch in its normal function and free of pathology is of utmost importance. Therefore, it is of prime importance as a Pediatric Dentist to maintain the integrity of tooth in the dental arch till natural exfoliation takes place.1Paediatric dentistry is changing from surgical treatment planning to conserving primary teeth till their natural exfoliation occurs for proper occlusal guidance and also aid in mastication. Restoration is carried out in carious teeth involving enamel and dentine and pulp therapy in those which are showing pulpal and peri-radicular involvement.2

            Pulpectomy procedure consists of various steps out of which absolute chemo-mechanical preparation of the root canal system is a requisite for a successful endodontic treatment.  Studies have shown higher frequency of post-endodontic pain following multiple visits as compared to single-visit endodontic treatments.3

            Conventionally, manual K-files have proven to be a gold standard providing excellent tactile control and sharp, long-lasting cutting surfaces. Despite the widespread use of manual instrumentation for pulpectomy in primary teeth, there is incidence of post-operative pain due to linear filing motion.2The post-endodontic pain may be caused due to ongoing inflammatory processes or changes in the periapical tissue pressure post instrumentation.4

            Although, K-files have aided in the pediatric endodontic treatment since ages and proved successful yet there is a need felt to introduce a newer filing system to reduce the incidence of post endodontic pain.5Rotary instruments were introduced to Paediatric dentistry by Barr et al in 2000.With the development of nickel–titanium (NiTi) rotary shaping systems in the recent past, a reduction in the timing and increased clinical efficacy has been seen.5

            The NiTi alloy proves more effective for cleaning the tortuous and irregular canal walls of the primary teeth due to, Greater elasticity, Central canal preparation, Less apical transportation, Use of lesser number of files. Hence it marks a far better choice for Paediatric endodontic procedures in the upcoming era. 6

            When literature search was carried out in last three months, there were no studies conducted in Indian scenario and worldwide regarding post- operative pain using Hand Files and Rotary Files after Single Sitting Pulpectomy. So, an attempt is made to carry out this research to evaluate and compare   the post-operative pain using Hand Files and Rotary Files After Single Sitting Pulpectomy. 
Close