| CTRI Number |
CTRI/2025/07/090862 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of hand held and rotary endodontic files in pediatric patients undergoing root canal treatment. |
|
Scientific Title of Study
|
Comparison of instrumentation time, Obturation quality and Post operative pain using manual and pediatric rotary files- a randomised 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 |
Dr Amruta Chowdhary |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Room no. 4, Department of pediatric and preventive dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar University, Mullana
Ambala
HARYANA
133207
India |
| Phone |
9958079274 |
| Fax |
|
| Email |
amuchowdhary99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetu Jain |
| Designation |
Reader |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Room no. 4, Department of pediatric and preventive dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar University, Mullana
Ambala
HARYANA
133207
India |
| Phone |
9813094542 |
| Fax |
|
| Email |
neetujain@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Chowdhary |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Room no. 4, Department of pediatric and preventive dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar University, Mullana
Ambala
HARYANA
133207
India |
| Phone |
9958079274 |
| Fax |
|
| Email |
amuchowdhary99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Amruta chowdhary |
| Address |
Room no. 4, Department of pediatric and preventive dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar University, Mullana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nilesh Rathi |
102,Avenue daffodil, Golden street, Balewadi,pune-411045 |
| Kedo dental |
Kedo dental,no.1, 1st floor, shop no.4,Nehru nagar,1st street, Anna nagar west,Chennai-600040 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amruta chowdhary |
Maharishi markandeshwar college of dental sciences and research |
Room no. 4, Department of pediatric and preventive dentistry, Maharishi Markandeshwar University, Mullana
Ambala
HARYANA |
9958079274
amuchowdhary99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children of the age group 3-10 years
Fully erupted primary teeth
Teeth with two third of tooth root and intact apex
Children exhibiting Positive behaviour (Frankel 3 and 4) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual pediatric files |
Traditional pediatric manual K-files for cleaning and shaping of root canals in primary teeth |
| Intervention |
Pediatric endodontic rotary files |
Advanced pediatric endodontic rotary files- Baby blue and Kedo S plus files will be used on patients undergoing pulpectomy (Root canal treatment) to evaluate instrumentation time, Obturation quality and immediate post operative pain. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Fully erupted primary teeth
Teeth with two third of tooth root and intact apex
Children exhibiting Positive behaviour (Frankel 3 and 4) |
|
| ExclusionCriteria |
| Details |
Tooth having crack, internal/external resorption
Any Calcifications/ Furcation involvement / mobility
Gross loss of tooth structure.
Periapical infections involving the crypts of succedaneous tooth |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of clinical efficacy in terms of instrumentation time, postoperative pain and obturation quality in patients undergoing root canal treatment after using manual and pediatric rotary files. |
Data will be evaluated at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of instrumentation time, obturation quality & postoperative pain using manual & pediatric rotary files. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Present in vivo study will be carried out on 45 primary teeth of Healthy children aged 3-10 years in the Department of Pediatric and Preventive Dentistry, MMCDSR, MM(DU), to compare the instrumentation time, obturation quality and post- operative pain using manual (K files)l and pediatric rotary file (Baby blue and Kedo S plus). The selected participants according to inclusion and exclusion criteria of the study will be randomly divided into three equal groups using Lottery Method. A qualified pediatric dentist will undertake all pulpectomy procedures and Instrumentation time will be noted followed by evaluation of the quality of obturation using Coll and Sadrian criteria. Post-operative pain will be assessed after 24 hours. The collected data will be systematically tabulated and subjected to statistical analysis. |