| CTRI Number |
CTRI/2025/04/084040 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the efficiency of two types of instruments during treatment of primary teeth in children |
|
Scientific Title of Study
|
Evaluation of clinical efficiency of two single file NiTi rotary systems in performing root canal treatment in primary teeth. |
| 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 Lomada Lakshmidevi |
| Designation |
Post Graduate student. |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive Dentistry, Block- 3, Room number - 5.
Vishnu Dental College,
Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
516355
India |
| Phone |
9676205997 |
| Fax |
|
| Email |
lakshmidevilomada123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ahalya penmatsa |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive Dentistry, Block- 3, Room number - 5.
Vishnu Dental College,
Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
516355
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahalya penmatsa |
| Designation |
Reader |
| Affiliation |
Vishnu Dental College |
| Address |
Department of pedodontics and preventive Dentistry, Block- 3, Room number - 5.
Vishnu Dental College,
Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH
516355
India |
| Phone |
9010427724 |
| Fax |
|
| Email |
ahalya.p@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram 534202-West Godawari District, Andhra Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Dr Lomada Lakshmidevi |
| Address |
Department of Pedodontics and Preventive Dentistry, Block- 3, Room number-5, Vishnu Dental College, Vishnupur, Bhimavaram- 534202, West Godawari District, Andhra Pradesh,India |
| 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 |
| Lomada Lakshmidevi |
Vishnu Dental College |
Department of pedodontics and preventive Dentistry, Block- 3, Room number - 5,
Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH |
09676205997
lakshmidevilomada123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kedo-S endorotary file system |
The biomechanical preparation of the deciduous molar root canal will be done using 18 mm length Kedo-S endorotary file system. After irrigation of the root canal, Obturation will be done using zinc oxide eugenol cement. Quality of
obturation will be assessed using post operative radiograph. |
| Intervention |
XP- Endoshaper rotary file system. |
The biomechanical preparation of the deciduous molar root canal will be done using 21 mm length XP- endoshaper rotary file.After irrigation of the root canal, Obturation will be done using zinc oxide eugenol cement. Quality of
obturation will be assessed using post operative radiograph. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 4-9 years of age.
2. Pulpectomy requiring single or two visits.
3. Children without any systemic diseases.
4. Primary teeth with sinus tract,abscess but
without any signs of resorption.
5. Cooperative child: Frankels positiveand
definitely positive patients. |
|
| ExclusionCriteria |
| Details |
1.Children with systemic diseases. And those with special health care needs.
2.Uncooperative patients
3.Multiple visit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of obturation
|
The Quality of obturation will be assessed radiographically at 0 minutes immediately after the obturation (immediate post operative) on the same day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumentation time |
The time required for instrumentation will be measured at - Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/04/2025 |
| 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="2"
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
|
|
Brief Summary
|
Screening of 4-9 years old patients attending outpatient
department will be done. Details of the study will be explained to the patients and
parents, with written informed consent obtained. Based on inclusion and exclusion
criteria a total of 50 primary teeth will be included and divided into 2 equal groups
with n= 25 in each group. Group 1 includes Kedo-S and group 2 includes
Xp-endoshaper. A standard protocol will be followed for pulpectomy and
radiographic method of working length determination will be done. BMP will be done
using respective rotary file systems in both the groups and instrumentation time will
be recorded in seconds using stop watch, followed by irrigation using 2.5% sodium
hypochlorite. Obturation will be done using zinc oxide eugenol cement. Quality of
obturation will be assessed using post operative radiograph based on Coll and Sadrian
criteria given in the year 1996. And it will be graded and scored as under fill (1),
optimum fill (2), overfill (3), and presence or absence of voids. Obtained data will be
subjected to statistical analysis. |