| CTRI Number |
CTRI/2024/12/078812 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the efficiency of rotary file systems for kids |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Efficiency of Pediatric Single Rotary File Systems for Pulpectomy in
Primary Molars – An In Vivo 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 |
Lakshmi Prasadh N |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, Surajkund, Badkal road
Faridabad
HARYANA
121004
India |
| Phone |
07010735851 |
| Fax |
|
| Email |
lakshmiprasadhnethaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avantika Tuli |
| Designation |
Head of the Department |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room No. 9, Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Suraj Kund, Badkal Road, Faridabad, Haryana
HARYANA
121004
India |
| Phone |
9634336684 |
| Fax |
|
| Email |
avantikatuli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi Prasadh N |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, Surajkund, Badkal road
Faridabad
HARYANA
121004
India |
| Phone |
07010735851 |
| Fax |
|
| Email |
lakshmiprasadhnethaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 9, Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Suraj Kund, Badkal Road, Faridabad, Haryana 121004 |
|
|
Primary Sponsor
|
| Name |
Lakshmi Prasadh N |
| Address |
Manav Rachna Dental College, Suraj Kund, Badkal Road, Faridabad, Haryana 121004 |
| 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 Lakshmi Prasadh N |
Manav Rachna Dental College |
Q Block, Basement Floor, Room No 9, Manav Rachna Dental College, Surajkund, Badkal road
Faridabad
HARYANA |
7010735851
lakshmiprasadhnethaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo S Plus file |
During Biomechanical preparation of pulpectomy, this will be used in single visit for 10-15 minutes |
| Comparator Agent |
Kedo S Square File |
To perform biomechanical preparation for pulpectomy, this will be used in a single visit for a maximum of 10–15 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
a) Normal, Healthy Children between 4 to 8 years
b) Frankl’s Behaviour Rating 3 (positive), 4 (definitely positive)
c) Primary molars with irreversible pulpitis
d) Primary molars with no signs of pathological resorption
e) IOPA Radiograph examination revealing primary molars with two thirds of each root remaining. |
|
| ExclusionCriteria |
| Details |
a) Primary molars with unrestorable crown structures.
b) Primary molars with perforated pulpal floor and sinus tract.
c) Primary molars with intraoral & extraoral swelling.
d) Primary molars with Grade III, IV mobility.
e) Children with special healthcare needs. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical efficiency of
pediatric single rotary file systems by
assessing:
Instrumentation time
Obturation time
Obturation quality |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare patient discomfort levels in
children during the pulpectomy
procedure using single rotary files
systems |
At Baseline |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/01/2025 |
| 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 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
|
|
Brief Summary
|
For the
morphologically challenging primary root canals, pulpectomy serves as gold
standard therapeutic treatment. Manual hand files has various limitations
such as time consuming and occurrence of iatrogenic errors. Rotary files
exclusively for primary tooth were introduced in India through KEDO Rotary files.
Though the dual rotary file systems are
highly successful, the recently introduced single rotary file systems posses a
better features and quality than the former. Among the single rotary files, two different generations are introduced whose clinical efficiency has never been evaluated and we aim to find the better file among the Two generations of single rotary files |