| CTRI Number |
CTRI/2025/02/080459 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Quality of Root Canal Fillings in Primary Molars of Children Aged 4-9 Years Using Hand and Rotary Instruments: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Evaluating the quality of obturation after pulpectomy of primary molars in children aged 4-9 years using hand and rotary instrumentation- A randomised 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 Shivayogi M Hugar |
| Designation |
Professor |
| Affiliation |
KAHERs KLE V.K. Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE V.K.
Institute of Dental Sciences, JNMC Campus, Nehru NAgar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9130418503 |
| Fax |
|
| Email |
drhugarsm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivayogi M Hugar |
| Designation |
Professor |
| Affiliation |
KAHERs KLE V.K. Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE V.K.
Institute of Dental Sciences, JNMC Campus, Nehru NAgar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9130418503 |
| Fax |
|
| Email |
drhugarsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Sunil Kumthekar |
| Designation |
Post Graduate Student |
| Affiliation |
KAHERs KLE V.K. Institute of Dental Sciences, Belagavi |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE V.K.
Institute of Dental Sciences, JNMC Campus, Nehru NAgar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9130418503 |
| Fax |
|
| Email |
snehalkumthekar1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, KLE VK Institute of Dental Sciences, Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Sunil Kumthekar |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Neharu Nagar, Belagavi, 590010, Karnataka, 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 |
| Dr Snehal Sunil Kumthekar |
KLE VK Institute of Dental Sciences |
Department of Pediatric
and Preventive
Dentistry, Department
No. 6, First floor,
KAHERs KLE VK
Institute of Dental
Sciences, JNMC
Campus, Nehru Nagar,
Belagavi
Belgaum
KARNATAKA
9130418503
snehalkumthekar1999
@gmail.com
Details of Ethics
Committee
Name of Committee Approval Status Date of Ap
Belgaum
KARNATAKA |
9130418503
snehalkumthekar1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Hand files |
To check obturation quality
using Hand Files for single
sitting Pulpectomy procedures.
Treatment will be done in 45
minutes |
| Intervention |
Kedo nano plus rotary files |
To check obturation quality
using Kedo nano plus rotary files for single
sitting Pulpectomy procedures.
Treatment will be done in 45
minute |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age group of 4-9 years
2. Children with Frankl’s behavior rating scale of definitely positive (++) and positive (+)
3. Tooth with the history of spontaneous pain
4. Tooth with irreversible pulpitis
5. Primary molars with at least remaining two third of the root length |
|
| ExclusionCriteria |
| Details |
1. Children with systemic diseases and special health care needs
2. Non-vital teeth having signs of abscess, sinus and fistula
3. Primary molars with pathologic mobility and evidence of root fracture, trauma
4. Primary molars having furcation radiolucency
5. Primary molars with calcified root canals
6. Primary molars with more than two third root resorption, internal resorption and developmental anomalies
7. Patients who are not willing to undergo treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Obturation Quality |
Postoperative first Radiographic assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumentation time |
From starting of CMP to the last files used |
| Postoperative Pain |
At 24hrs, 48hrs,72hrs |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
10/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The Principal Investigator will perform the procedure under Standard Operating Protocols. Patients allocated to Group I will be treated using Hand files and Group II will be treated using Kedo nano plus rotary files. The teeth selected for the study will be isolated using Rubber dam and the pulpectomy procedure will be carried out in primary molars. The post-operative evaluation of the obturation quality will be done using Modified Coll and Sedrian criteria. Instrumentation Time will be recorded using stopwatch. Evaluation of postoperative pain will be done using the Wong-Baker Faces Pain Rating Scale. Parents/guardians will be instructed to record pain on the scale at 24, 48, and 72 h, which will be given to them along with the patient’s information sheet. All the pain scores will be recorded telephonically and the collection of the Patient information sheet will be done on the subsequent follow up visit. Postoperative instructions will be given. |