CTRI Number |
CTRI/2025/06/088467 [Registered on: 10/06/2025] Trial Registered Prospectively |
Last Modified On: |
09/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effectiveness of different cleaning instruments in milk teeth |
Scientific Title of Study
|
Effectiveness of different rotary files during bio-mechanical preparation in primary teeth - A Randomized Controlled 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 Patnana Arun Kumar |
Designation |
Assistant Professor |
Affiliation |
AIIMS Rajkot |
Address |
Room No 115, Night Shelter Building
AIIMS Hospital, Khandheri, Para Pipaliya
Rajkot - Gujarat
Rajkot GUJARAT 360006 India |
Phone |
9966117228 |
Fax |
|
Email |
arun0550@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Patnana Arun Kumar |
Designation |
Assistant Professor |
Affiliation |
AIIMS Rajkot |
Address |
Room No 115, Night Shelter Building
AIIMS Hospital, Khandheri, Para Pipaliya
Rajkot - Gujarat
GUJARAT 360006 India |
Phone |
9966117228 |
Fax |
|
Email |
arun0550@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Patnana Arun Kumar |
Designation |
Assistant Professor |
Affiliation |
AIIMS Rajkot |
Address |
Room No 115, Night Shelter Building
AIIMS Hospital, Khandheri, Para Pipaliya
Rajkot - Gujarat
GUJARAT 360006 India |
Phone |
9966117228 |
Fax |
|
Email |
arun0550@gmail.com |
|
Source of Monetary or Material Support
|
Para Pipaliya, Khandheri, AIIMS Hospital, AIIM, Rajkot, Gujarat - 360006 |
|
Primary Sponsor
|
Name |
AIIMS Rajkot |
Address |
All India Institute Of Medical Sciences (AIIMS),
Khanderi, Para Pipaliya, Rajkot, Gujarat, INDIA, 360006 |
Type of Sponsor |
Government medical college |
|
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 Patnana Arun Kumar |
AIIMS Rajkot |
Room no 115, Night Shelter building
AIIMS Hospital, Khandheri,
Para Pipaliya, Rajkot Rajkot GUJARAT |
9966117228
arun0550@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: K040||Pulpitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Rotary files for permanent teeth |
The rotary files for permanent teeth will be used for chemomechanical preparation in primary teeth.
The duration of treatment with control group instruments is approximately 5-7 minutes. |
Intervention |
Rotary files for primary teeth |
The rotary files for primary teeth will be used for chemo-mechanical preparation during pulpectomy in primary teeth.
The duration of treatment with intervention is approximately 3-5 minutes. |
|
Inclusion Criteria
|
Age From |
5.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
Children in the age group of 5 – 9 years age; Children with primary mandibular second molar teeth that are indicated for pulpectomy; Children with definitely positive or positive behaviour. |
|
ExclusionCriteria |
Details |
Specially challenged children and children with primary teeth with internal or external resorptions. |
|
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 |
Instrumentation time |
Baseline (at the time of intervention) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Obturation quality |
Baseline (at the time of intervention) |
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 4 |
Date of First Enrollment (India)
|
23/06/2025 |
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="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
|
Dental caries is one of the prevalent oral diseases in children affecting the overall quality of children. The management of deep dental caries involving the pulp includes the pulpectomy of the specific teeth. There are various instruments suggested for bio-mechanical preparation during pulpectomy in primary teeth. The rotary instruments designed for the permanent teeth are routinely used in primary teeth as well. In addition, the rotary files specific to the primary teeth have also been designed and in use for years. Though there are multiple studies comparing hand instruments to rotary instruments, no studies published that evaluate the effectiveness of rotary instruments designed for permanent teeth and primary teeth.
The eligible participants as per the inclusion and exclusion criteria will be recruited from the OPD of the Department of Dentistry. A random sequence of the experimental materials will be developed before the start of the study, and allocation concealment will be done using sealed envelopes. After obtaining the consent, the pulpectomy procedure will be initiated and the biomechanical preparation will be done with either regular or primary teeth-specific rotary files selected based on the randomisation codes. All the procedures will be done by single experienced Pediatric Dentist. The instrumentation time will be noted by the dental chair assistant and the obturation quality will be noted by an outcome assessor who is blinded to the rotary instruments used. |