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CTRI Number  CTRI/2024/01/062122 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 25/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the quality of root filling, time of treatment and pain after treatment using three different cleaning systems 
Scientific Title of Study   Quality of obturation, instrumentation time and post-operative pain using three different file systems in primary teeth - 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  Shaik Sameera 
Designation  Post graduate student 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh

Nellore
ANDHRA PRADESH
524003
India 
Phone  8919116647  
Fax    
Email  shaiksameera2407@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sivakumar Nuvvula 
Designation  Professor and Head of the Department 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh

Nellore
ANDHRA PRADESH
524003
India 
Phone  9441624429  
Fax    
Email  dentist4kids@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K V Saikiran 
Designation  Assistant Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh

Nellore
ANDHRA PRADESH
524003
India 
Phone  8125774535  
Fax    
Email  saikiran4u2008@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatric and Preventive Dentistry Division-7 Room number-7 Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra pradesh  
 
Primary Sponsor  
Name  Dr Shaik Sameera 
Address  Narayana Dental College and Hospital Chinthareddypalem Nellore Andhra Pradesh 
Type of Sponsor  Other [Self sponsor] 
 
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 Shaik Sameera  Narayana Dental College and Hospital  Divivsion-7 Department of Paediatric and Preventive Dentistry Nellore
Nellore
ANDHRA PRADESH 
8919116647

shaiksameera2407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Narayana Dental college and hospital  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-SH and Pedo Flex file  Kedo-SH hand file consists of P1, P2, and P3 stainless steel files and D1, E1, and U1 nickel–titanium files. The total length of the file is 16 mm with a flute length of 12 mm. Pedo-Flex Files made of NITI, durable and high-temperature rebound memory with 16mm length and 4-6% taper. 
Comparator Agent  Manual K-files  K files are the universal standard for canal negotiation, shaping, and recapitulation of root canal systems. They are generally used with a quarter turn “watch-winding” motion and vertical pull. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Children aged between 4-9 years who needed endodontic treatment, who signed the consent form.
2.Patient’s having pain during night.
3.Absence of internal or external pathologic root resorption
4.Vital or nonvital teeth without sinus tract.
5.Presence of adequate coronal tooth structure to receive stainless steel crown.
 
 
ExclusionCriteria 
Details  1.Children lacking cooperative ability.
2.Children with underlying systemic diseases.
3.Children with special health care needs.
4.Children using continuous medication or who had taken analgesics or anti-inflammatories up to 12 hours before the procedure were excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare quality of Obturation and Instrumentation time using different Rotary file systems with Manual Instrumentation in Primary teeth  Post operative radiograph will be taken after obturation
Instrumentation time was recorded using stop watch 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Post-Operative pain using different Rotary file systems with Manual Instrumentation in Primary teeth  Pain assessment will be done after the procedure 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   07/02/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Pulpectomy is a procedure involving complete removal of pulp tissue from the root canal space in primary teeth followed by filling it with an inert resorbable material. Using hand files for instrumentation of the primary root canals has been well documented in the literature. There are certain potential limitations like increased canal preparation time, uneven preparation of root canal space associated with the use of hand files despite its widespread usage for the instrumentation of primary root canals. To overcome the disadvantages of the manual instrumentation and to preserve the tortuous root canal path of the primary teeth, rotary instrumentation was introduced into paediatric dentistry. An increasing volume of research acknowledges the significance of minimizing postoperative pain in pediatric endodontics using motorized instrumentation and specific pediatric rotary files. Hence, the present study intends to compare the quality of obturation, instrumentation time and intensity of postoperative pain using manual instrumentation and rotary instrumentation.


Aim: The aim of the study is to evaluate the quality of obturation, instrumentation time and postoperative pain using pedoflex file, kedo-SH, and reciprocating hand K-files in primary teeth. 

Objectives: To compare the quality of obturation, instrumentation time and postoperative pain during root canal preparation.

To evaluate the obturation quality, instrumentation time during root canal preparation and intensity of postoperative pain after pulpectomy in primary teeth employing manual instrumentation(k-file) and rotary instrumentation (pedo flex file and kedo-SH file)

The randomized clinical trial was carried out in the Department of Paediatric and Preventive Dentistry,

Narayana Dental College and hospital, Nellore. The informed consent was obtained from the

parents of the children who participated in the study.

Children between 4-9 years of age requiring pulpectomy were randomly selected and allotted

to one of the three groups according to the computer generated randomization sequence where instrumentation was done using: Group 1: Manual K-files (15-30) (Mani); Group 2: Pedo Flex file; Group 3: Kedo-SH. The working length was determined with the pre-operative radiograph using Ingle’s radiographic method. Local anesthesia was administered using 2% lignocaine with 1:2,00,000 adrenaline. The tooth indicated for pulpectomy was isolated using rubber dam. Using No.6 round bur (Mani) was used in a high speed hand piece to remove the superficial caries and No.330 pear shaper bur (Mani) was used to completely de-roof thepulp chamber. No.10 size K file (Mani) was used to determine the patency of the canals. The canal preparation was done using: 

Group 1: Twenty eight teeth were instrumented using K-files from size 15 to size 30 (Mani) in quarter pull turn method, 

Group 2: Twenty-eight teeth were instrumented using Pedo Flex file,

Group 3: Twenty-eight teeth were instrumented using Kedo-SH file. 

The time taken for the instrumentation of the canals was recorded in seconds using a stop watch by an assistant. The canals were then irrigated and obturated. A postobturation radiograph was taken to assess the quality of obturation. Pain assessment is done using Memoji’s pain scale.


 
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