| CTRI Number |
CTRI/2026/01/100248 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of obturation quality, and instrumentation time following the use of files used for cleaning the root canals |
|
Scientific Title of Study
|
Comparative evaluation of two pediatric rotary file system on primary mandibular molars- A randomized control 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 Prachi Vats |
| Designation |
MDS student |
| Affiliation |
pt BD sharma university |
| Address |
Room no 6 , Department of pediatric and preventive dentistry , Sudha Rustagi College of Dental Sciences And Research , faridabad
Faridabad
HARYANA
121002
India |
| Phone |
08368952027 |
| Fax |
|
| Email |
prachi2405vats@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Bhavna Gupta Saraf |
| Designation |
Proffessor and HOD |
| Affiliation |
Sudha Rustagi College of Dental Sciences, Faridabad |
| Address |
Room no. 6, Department of Pedodontics, Sudha Rustagi College of Dental Sciences, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
9899124779 |
| Fax |
|
| Email |
guptabhavna2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Bhavna Gupta Saraf |
| Designation |
Proffessor and HOD |
| Affiliation |
Sudha Rustagi College of Dental Sciences, Faridabad |
| Address |
Room no. 6, Department of Pedodontics, Sudha Rustagi College of Dental Sciences, Faridabad, Haryana
Faridabad
HARYANA
121002
India |
| Phone |
9899124779 |
| Fax |
|
| Email |
guptabhavna2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences, Faridabad, Haryana , 121002 |
|
|
Primary Sponsor
|
| Name |
Dr. Prachi Vats |
| Address |
Pno. 756/2 Near Swati Modern Public School , Mundka , New Delhi , 110041 |
| Type of Sponsor |
Other [(SELF)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prachi Vats |
Sudha Rustagi College of Dental Sciences |
Room no 6 , Department Of Pediatric and Preventive Dentistry, Sudha Rustagi College of Dental Sciences, Faridabad, Haryana , 121002
Faridabad
HARYANA |
08368952027
prachi2405vats@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRCDSR-Intsitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Tooth Indicated For Pulpectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kedo Nano Plus Rotary File |
Kedo Nano Plus is nano-coated version offering greater flexibility and fracture resistance for curved canals will be used for shaping and cleaning of root canals in a single visit in primary mandibular molars |
| Intervention |
Kedo S Plus Rotary File |
Kedo S Plus is a heat-treated NiTi single-file rotary system for efficient shaping and cleaning of root canals in a single visit in primary mandibular molars |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient should be of age 4-9 years
2.Patient should exhibit frankel’s behaviour rating scale score of 3 and 4 i.e. positive (+) and definitely positive (++)
3.Primary molars with deep caries which can be vital or non vital.
4.Absence of resorption in cervical and internal root.
5.Minimum of two-thirds of the remaining root length
6.Minimum tooth structure which can hold a rubber dam. |
|
| ExclusionCriteria |
| Details |
1.Children with special health care needs and underlying systemic diseases and allergies will be excluded
2.Children who lack cooperative capabilities will be excluded.
3.Teeth with aberrant pathologic mobility and preshedding will be excluded.
4.Teeth with internal or external root perforation.
5.Teeth exhibiting perforation of the pulpal floor.
6.Teeth with gross bone loss in furcation area or apex of the teeth
7.Teeth with presence of less than two-thirds of the root will be 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
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of instrumentation time and obturation quality of Kedo S rotary File and Kedo Nano rotary File |
Comparison of instrumentation time starting from insertion of file till completion of cleaning and shaping and obturation quality following the use of Kedo S rotary File and Kedo Nano rotary File by coll and sadrian method in single sitting i.e. same day. outcome assessed again after 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
30/01/2026 |
| 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
|
A RANDOMIZED CLINICAL STUDY WILL BE CONDUCTED ON 38 CHILDREN AGED 4–9 YEARS, WHO WILL BE RANDOMLY DIVIDED INTO TWO GROUPS (KEDO S PLUS AND KEDO NANO PLUS). AFTER ACCESS OPENING AND GLIDE PATH PREPARATION, CANAL INSTRUMENTATION WILL BE PERFORMED USING THE RESPECTIVE ROTARY FILE SYSTEMS, AND INSTRUMENTATION TIME WILL BE RECORDED BY A BLINDED ASSISTANT. OBTURATION WILL BE DONE WITH IODOCURE, FOLLOWED BY RADIOGRAPHIC EVALUATION BY COLL AND SADRIANS CRITERIA AND THE RESULTS WILL BE STATISTICALLY ANALYZED. |