| CTRI Number |
CTRI/2024/06/069202 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluating Filling Quality in Childrens Back Lower Teeth |
|
Scientific Title of Study
|
Evaluating Quality of Obturation in Primary Posterior Mandibular Teeth: A Comparative Clinical Study 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 |
Nandini Devi M |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
06380593906 |
| Fax |
|
| Email |
mnandinidevi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital,162,Poonamallee high road,Velappanchavadi
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 Nandini Devi M |
Saveetha Dental College and Hospital |
162 , Poonamallee high road, Velapanchavadi,
Chennai-600077
Chennai
TAMIL NADU |
6380593906
mnandinidevi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College-Institutional Human Ethical 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 |
Hand K file |
Conventional manual file system from Mani used to do
pulpectomy |
| Intervention |
Kedo S Plus |
Rotary single file system from KEDO Dental used to
perform pulpectomy |
| Intervention |
Pro AF Baby |
Rotary sequential file system from kids-e-dental used to
perform pulpectomy |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
healthy children requiring pulpectomy for one of their primary second
mandibular molars.root length, available coronal structure,
resorption, special needs, and systemic diseases. Inclusion criteria
included primary mandibular molars, whether vital or non-vital,
without a sinus tract, showing no signs of internal or external
pathologic root resorption, and possessing adequate coronal tooth
structure for stainless steel crown placement |
|
| ExclusionCriteria |
| Details |
children lacking cooperative ability, those with underlying systemic
diseases, and those with special healthcare needs |
|
|
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 |
Immediate post-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instrumentation time |
seconds |
| Post-operative pain |
12, 24, and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - 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 - Informed Consent Form
Response - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [152111002.sdc@saveetha.com].
- For how long will this data be available start date provided 04-03-2025 and end date provided 04-03-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- 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. Single file systems have the advantages of faster completion of treatment and lesser pain after completion of treatment.In this trial, all three types of files are used during pulpectomy in children to assess which provides better obturation with a lesser instrumentation time. |