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CTRI Number  CTRI/2025/06/088467 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of different cleaning instruments in milk teeth 
Scientific Title of Study   Effectiveness of different rotary files during bio-mechanical preparation in primary teeth - A Randomized Controlled 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  Dr Patnana Arun Kumar  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot 
Address  Room No 115, Night Shelter Building AIIMS Hospital, Khandheri, Para Pipaliya Rajkot - Gujarat

Rajkot
GUJARAT
360006
India 
Phone  9966117228  
Fax    
Email  arun0550@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Patnana Arun Kumar  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot 
Address  Room No 115, Night Shelter Building AIIMS Hospital, Khandheri, Para Pipaliya Rajkot - Gujarat


GUJARAT
360006
India 
Phone  9966117228  
Fax    
Email  arun0550@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Patnana Arun Kumar  
Designation  Assistant Professor  
Affiliation  AIIMS Rajkot 
Address  Room No 115, Night Shelter Building AIIMS Hospital, Khandheri, Para Pipaliya Rajkot - Gujarat


GUJARAT
360006
India 
Phone  9966117228  
Fax    
Email  arun0550@gmail.com  
 
Source of Monetary or Material Support  
Para Pipaliya, Khandheri, AIIMS Hospital, AIIM, Rajkot, Gujarat - 360006 
 
Primary Sponsor  
Name  AIIMS Rajkot 
Address  All India Institute Of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 
Type of Sponsor  Government 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 Patnana Arun Kumar   AIIMS Rajkot  Room no 115, Night Shelter building AIIMS Hospital, Khandheri, Para Pipaliya, Rajkot
Rajkot
GUJARAT 
9966117228

arun0550@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Rotary files for permanent teeth   The rotary files for permanent teeth will be used for chemomechanical preparation in primary teeth. The duration of treatment with control group instruments is approximately 5-7 minutes.  
Intervention  Rotary files for primary teeth   The rotary files for primary teeth will be used for chemo-mechanical preparation during pulpectomy in primary teeth. The duration of treatment with intervention is approximately 3-5 minutes.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children in the age group of 5 – 9 years age; Children with primary mandibular second molar teeth that are indicated for pulpectomy; Children with definitely positive or positive behaviour.  
 
ExclusionCriteria 
Details  Specially challenged children and children with primary teeth with internal or external resorptions.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Instrumentation time  Baseline (at the time of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Obturation quality  Baseline (at the time of intervention) 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 4 
Date of First Enrollment (India)   23/06/2025 
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  

Dental caries is one of the prevalent oral diseases in children affecting the overall quality of children. The management of deep dental caries involving the pulp includes the pulpectomy of the specific teeth. There are various instruments suggested for bio-mechanical preparation during pulpectomy in primary teeth. The rotary instruments designed for the permanent teeth are routinely used in primary teeth as well. In addition, the rotary files specific to the primary teeth have also been designed and in use for years. Though there are multiple studies comparing hand instruments to rotary instruments, no studies published that evaluate the effectiveness of rotary instruments designed for permanent teeth and primary teeth. 

The eligible participants as per the inclusion and exclusion criteria will be recruited from the OPD of the Department of Dentistry. A random sequence of the experimental materials will be developed before the start of the study, and allocation concealment will be done using sealed envelopes. After obtaining the consent, the pulpectomy procedure will be initiated and the biomechanical preparation will be done with either regular or primary teeth-specific rotary files selected based on the randomisation codes. All the procedures will be done by single experienced Pediatric Dentist. The instrumentation time will be noted by the dental chair assistant and the obturation quality will be noted by an outcome assessor who is blinded to the rotary instruments used. 

 
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