| CTRI Number |
CTRI/2021/02/031400 [Registered on: 18/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Microbial evaluation of root canals after treatment with different instruments |
|
Scientific Title of Study
|
Evaluation of Anti-microbial
Efficacy of Root Canal Preparation With Manual K-files, H-files and Kedo-S Square Rotary Files In Primary
Teeth |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshimi Lakshmanan |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatrics and Preventive Dentistry, Saveetha Dental College and Hospitals, 162 Poonamallee High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8939346341 |
| Fax |
|
| Email |
lachulaxmanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatrics and Preventive Dentistry, Saveetha Dental College and Hospitals, 162 Poonamallee High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatrics and Preventive Dentistry, Saveetha Dental College and Hospitals, 162 Poonamallee High Road, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,
Saveetha Dental College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Lakshimi Lakshmanan |
| Address |
Department of Pediatrics and Preventive Dentistry, Saveetha Dental College and Hospitals, 162 Poonamallee High Road, Chennai |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| Lakshimi Lakshmanan |
Saveetha Dental College |
Department of Pediatrics and Preventive Dentistry, Saveetha Dental College and Hospitals, 162 Poonamallee High Road, Chennai
Chennai
TAMIL NADU |
8939346341
lachulaxmanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hand H-files |
hand instrument used for root canal preparation |
| Comparator Agent |
Hand K-files |
hand instrument used for root canal preparation |
| Intervention |
Kedo-S Square files |
single rotary file system used for root canal preparation |
|
|
Inclusion Criteria
|
| Age From |
4.00 Day(s) |
| Age To |
9.00 Day(s) |
| Gender |
Both |
| Details |
Treatment is limited to children with no systemic diseases, non-vital or vital pulp without a sinus tract, presence of enough coronal and root structure, no prior pulpectomy treatment on involved tooth, absence of perforation in the internal and/or external furcation area |
|
| ExclusionCriteria |
| Details |
children with systemic pathosis/ special health care needs, untoward reaction to local anesthesia, non-restorable teeth |
|
|
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 |
| Colony Forming Unit |
immediately after treatment (time points- not applicable) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2021 |
| Date of Study Completion (India) |
15/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endodontic treatment in primary teeth is challenging especially during biomechanical preparation of root canals. An efficient chemo-mechanical preparation is essential for effective canal disinfection and thereby contributes to the access of the endodontic procedure. Conventionally, hand files are used for cleaning and shaping and are time-consuming. Rotary instrumentation in pediatric dentistry is an emerging concept. A very few studies have compared the efficiency of rotary instrumentation for canal preparation in primary teeth. Thus the present study is undertaken to evaluate the cleaning efficacy of manual K-files, manual H-files and Kedo-S Square single file rotary system in primary teeth based on microbial estimation. |