| CTRI Number |
CTRI/2024/06/068867 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of quality of obturation and duration of instrumentation time during primary tooth root canal procedure with two different paediatric rotary files |
|
Scientific Title of Study
|
Evaluating Obturation Quality and Instrumentation time in Primary Maxillary Central Incisor Teeth: A Single blinded Randomized Clinical Trial of Two Rotary File Systems and Manual Instrumentation Based on the KEDOO Classification |
| 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 Balaji S |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9952207281 |
| Fax |
|
| Email |
balajimahadevan18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi Chennai
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital , 162 , Poonamallee high road, Velapanchavadi,
Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital |
| Address |
162 , Poonamallee high road, Velapanchavadi, Chennai-600077 |
| 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 |
| Dr Ganesh Jeevanandan |
Saveetha Dental College and Hospital |
Department of pediatric dentistry ,
room no 28,
162 , Poonamallee high road, Velapanchavadi, Chennai-600077 Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9884293869
helloganz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand K File |
Manual file system used to do pulpectomy |
| Intervention |
Kedo SG Blue files
|
Rotary file system used to perform pulpectomy.
Files is used only during mechanical preparation of the root canal during pulpectomy procedure. |
| Intervention |
Pro AF Baby Gold files |
sequential pediatric rotary file for pulpectomy.
Files is used only during mechanical preparation of the root canal during pulpectomy procedure. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria considered factors such as root length, coronal structure, resorption, and systemic health, with exclusion criteria addressing cooperation ability and underlying systemic diseases. Vital or non-vital primary maxillary central incisors without a sinus tract, absence of pathologic root resorption, nighttime pain, and sufficient coronal tooth structure were essential for inclusion. |
|
| ExclusionCriteria |
| Details |
uncooperative child
child with any systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of obturation using intraoral periapical radiograph- will be assessed as immediate post operative |
immediate postoperative radiograph taken post pulpectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumentation time |
immediate postoperative |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
28/06/2024 |
| 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="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [balajimahadevan18@gmail.com].
- For how long will this data be available start date provided 29-06-2024 and end date provided 15-07-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Pulpectomy can be done with manual or rotary, single or sequential file systems. Newer specialised pediatric rotary files enables for improvised pulpectomy procedure which can evaluated by obturation quality |