| CTRI Number |
CTRI/2025/07/090548 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study that compares the quality of treatment done inside the roots of primary teeth using two different rotary tools. |
|
Scientific Title of Study
|
Assessment of quality of obturation of root canals of primary molars using two pediatric rotary file systems: A comparative clinical study. |
| 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 SANJANA CHAKRAPANI |
| Designation |
Post graduate |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No. 8, Bommanahalli, Hongasandra, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9591660336 |
| Fax |
|
| Email |
sanjanachakrapani99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJANA CHAKRAPANI |
| Designation |
Post graduate |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No. 8, Bommanahalli, Hongasandra, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9591660336 |
| Fax |
|
| Email |
sanjanachakrapani99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYA SUBRAMANIAM |
| Designation |
PROFESSOR |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, Department of Pediatric and Preventive Dentistry, 4th floor, Room No. 8, Bommanahalli, Hongasandra, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
9844225624 |
| Fax |
|
| Email |
drpriyapedo@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SANJANA CHAKRAPANI |
| Address |
The Oxford Dental College,Department of Pediatric and Preventive Dentistry, fourth floor, Room No. 8, NH 44, Bommanahalli, Hongasandra, Bengauru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSanjana Chakrapani |
the oxford dental college |
Department of Pediatric and Preventive Dentistry, 4th floor, Room No. 8, Bommanahalli, Hongasandra, Bengaluru
Bangalore
KARNATAKA |
9591660336
sanjanachakrapani99@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kedo Nano Plus rotary file |
used for cleaning and shaping the root canals, according to manufacturer’s instructions for 15 minutes. |
| Intervention |
Kedo-S Plus rotary file |
used for cleaning and shaping the root canals, according to manufacturer’s instructions for a period of 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Young cooperative children with no history of systemic illness
2.Tooth with carious pulp exposure, diagnosed as having irreversible pulpitis
3.Tooth with at least 2/3rd of root length present
4.Tooth showing radiographic signs of pulpal or interradicular pathosis. |
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs
2. Tooth with severe mobility
3. Pathologic bone loss |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the quality of obturation of root canals of primary molars following preparation with Kedo-S Plus and Kedo Nano plus pediatric rotary file systems. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/07/2025 |
| 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)
|
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
|
Sixty primary molars will be allocated by simple
randomization technique to two groups of 30 teeth each:
Group I: Root canals will be prepared using Kedo-S Plus
rotary file. (Kedo Dental, India)
Group II: Root canals will be prepared using Kedo Nano
plus rotary file. (Kedo Dental, India)
Prior
to the procedure pre-operative intra-oral periapical radiograph of the primary
molar will be obtained. Local anaesthesia will be administered with 2%
lignocaine hydrochloride containing adrenaline at a concentration of 1:80000.
Dental caries and overhanging enamel will be removed with a #330 high speed bur
under a water spray. Access to the coronal pulp chamber will be obtained using
a #4 round bur (Dentsply) and the entire roof of pulp chamber will be removed.
Necrotic tissue from the pulp chamber will be removed using a sterile and sharp
spoon excavator. After obtaining straight line access, patency of the canal
will be established using a No.10 stainless steel K-file. Working length will
be determined 1mm short of the radiographic apex. The canals will be prepared
using rotary file with copious saline irrigation.
In
Group I, Kedo-S Plus rotary file and in Group II, Kedo Nano Plus rotary file
systems will be used for cleaning and shaping the root canals, according to
manufacturer’s instructions. Irrigation with saline will be carried out. Canals
will be dried with absorbent paper points and obturated with zinc oxide eugenol
cement (Zinc Oxide, DPI® ZINC OXIDE Manufactured by Dental Products
of India) (Eugenol, Prevest DentPro, India) using incremental filling technique.
The primary molar will be then restored with Type II glass ionomer cement
(Shofu, Shofu Inc. Japan). An immediate post-operative intra-oral periapical
radiograph of the primary molar will be taken. All the treated primary molars
will be given stainless crowns within 1 week of treatment.
Assessment of quality of obturation
The quality of
obturation will be assessed according to Mahtab Memarpour et al.
1=less
than or equal to half the root canal length was filled
2=more
than half the root canal length was filled but filling was not optimal
3=optimal
filling (canal filled to within 0-1.5 mm of the apex) and
4=filling
material extruding from the apex (overfilling)
The presence or
absence of voids, number and location of voids in each root canal (coronal,
middle, apical) will also be evaluated.
Data obtained will
be subjected to statistical analysis. |