| CTRI Number |
CTRI/2025/08/092913 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Preventive Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the time taken and pain after using different file techniques (hand, rotary, and special rotary) for cleaning primary molar teeth in children aged 6 to 8 years
|
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Scientific Title of Study
|
Comparative evaluation of the instrumentation time and post-operative pain of hand file, rotary file and controlled memory rotary file techniques in biomechanical preparation of primary molars: A randomized controlled 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 |
Nikita Kishor Jakhotiya |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital Debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India
Udaipur RAJASTHAN 313024 India |
| Phone |
7588718610 |
| Fax |
|
| Email |
nikitajakhotiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dinesh Rao |
| Designation |
HOD Pg guide |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital Debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India
Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Nikita Kishor Jakhotiya |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital debari Pacific Dental College And Hospital, Debari, Udaipur RAJASTHAN 313024 India
Udaipur RAJASTHAN 313024 India |
| Phone |
7588718610 |
| Fax |
|
| Email |
nikitajakhotiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental College And Hospital Debari Udaipur 313024 |
|
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Primary Sponsor
|
| Name |
Nikita Kishor Jakhotiya |
| Address |
Pacific Dental College And Hospital Debari Udaipur 313024 |
| Type of Sponsor |
Other [[Self]] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita Kishor Jakhotiya |
Pacific Dental College And Hospital Debari Udaipur 313024 |
Department of pediatric
and preventive dentistry
first floor room number
nine Pacific Dental
College And Hospital
Debari Udaipur 313024
Udaipur RAJASTHAN Udaipur RAJASTHAN |
7588718610
nikitajakhotiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A409||Streptococcal sepsis, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Controlled memory rotary files |
Cleaning and shaping of primary molars using controlled memory rotary files (CM rotary system).
Pre-instrumentation with K-file followed by CM rotary files using 300rpm and 2.4 Ncm torque. |
| Comparator Agent |
Hand Files |
It will be used for cleaning and shaping of primary molars using hand file. Manual instrumentation will be done using NiTi K-Flex files (15–35),and irrigation with NaOCl and saline irrigation and EDTA lubrication. |
| Intervention |
Rotary files |
Cleaning and shaping of primary molars will be done using rotary files (conventional NiTi rotary system).
Utilization of pediatric rotary files, for biomechanical preparation of primary molars. Pre instrumentation of the canals will be done using no. 15 NiTi-K flex file followed by Kids-e rotary files at 300 rpm and 2.4 Ncm torque. |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 to 8 years with at least one mandibular primary molar requiring pulpectomy
Primary mandibular molars with asymptomatic irreversible pulpitis with a minimum of two third of root length remaining.
Preoperative radiograph revealing absence of periapical lesion or interradicular radiolucency.
Children who are cooperative and able to sit through treatment procedures.
Parental or guardian consent and child assent obtained for participation in the study.
|
|
| ExclusionCriteria |
| Details |
Patient with any systemic diseases or disabilities or incompetent to understand instructions
Patient with history of taking analgesics 12 hour before and after the pulpectomy procedure.
Teeth with internal or external root resorption extending beyond one-third of the root.
Teeth with pathological mobility or advanced periodontal involvement.
Presence of periapical or furcal radiolucency exceeding 5 mm.
History of acute dental pain or abscess within the past 48 hours.
Teeth previously treated endodontically or with open apex.
Children with a known allergy to local anesthetics or endodontic materials.
Uncooperative behavior making it difficult to complete the procedure under routine clinical settings.
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|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time of instrumentation and postopertaive pain with rotary and control memory rotary |
instrumrntation time and postoperative pain at an interval of 6 24 48 72 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Behavioral response of the child
Postoperative analgesic consumption incidence of intraoperative complications |
instrumentation time postoperative pain analgesic consumption at an interval of 6 24 48 72 hour |
|
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Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/08/2025 |
| 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 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
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Brief Summary
|
Preservation of primary teeth until their natural exfoliation is a key objective in paediatric dentistry. Primary molars are vital for maintaining arch length, guiding permanent tooth eruption, supporting mastication, and promoting overall oral health. When these teeth are compromised by extensive caries or pulpal pathology, pulpectomy is often the treatment of choice to retain them until natural exfoliation. Pulpectomy involves the removal of necrotic or irreversibly inflamed pulp tissue, followed by biomechanical preparation, disinfection, and obturation. Among these, biomechanical preparation is crucial for cleaning and shaping the canals and eliminating microbial load. The success of this step is highly influenced by the instrumentation technique used. Traditionally, stainless steel hand files have been employed for this purpose. While effective, they are time-consuming, technique-sensitive, and often difficult to use in uncooperative paediatric patients due to prolonged chair time. To address these challenges, rotary instrumentation systems which was originally designed for permanent teeth, know have been adapted for use in primary molars. These systems offer advantages such as uniform canal shaping, reduced operator fatigue, and significantly shorter instrumentation time. However, their limited flexibility poses challenges in navigating the narrow, curved canals of primary molars. Recent innovations like controlled memory (CM) rotary files offer improved flexibility and resistance to cyclic fatigue, allowing safer navigation through complex canal anatomies with less apical debris extrusion. This is particularly important since debris extrusion can lead to post-operative pain, which is a significant factor in a child’s perception of dental treatment. Despite the increasing adoption of rotary and CM rotary instrumentation in paediatric dentistry, limited clinical trials have directly compared these techniques with conventional hand files in primary molars, particularly focusing on both instrumentation time and post-operative pain. Most available studies are in vitro or observational, underscoring the need for well-designed randomized controlled clinical trials in this area. This study aims to fill this gap by conducting a randomized controlled clinical trial to evaluate and compare the instrumentation time and post-operative pain associated with hand files, rotary files, and CM rotary files during biomechanical preparation of primary molars in children aged between 8 and 12 years. By assessing both clinical efficiency and patient-centered outcomes, this study seeks to identify the most suitable instrumentation technique for paediatric endodontic practice. The findings of this study will contribute valuable insights into improving the quality of care, reducing treatment time, enhancing patient comfort, and ultimately supporting better treatment outcomes in paediatric dentistry. |