| CTRI Number |
CTRI/2024/08/072790 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Anti microbial efficacy of various file system in deciduous teeth - A Randomised Clinical trial |
|
Scientific Title of Study
|
Anti microbial efficacy of root canal preparation in deciduous teeth with hand file, Single rotary file system, Sequential multi file rotary system - 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 |
Manisha Bala Rathy Rajadurai |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
Clinic 28, department of pediatric and preventive dentistry, Saveetha dental college
Chennai
TAMIL NADU
600077
India |
| Phone |
09791113493 |
| Fax |
|
| Email |
152211005.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha dental college |
| Address |
Clinic 28, department of pediatric and preventive dentistry, Saveetha dental college, seneerkuppam
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 |
| Address |
Clinic 28, department of pediatric and preventive dentistry, Saveetha dental college, seneerkuppam
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals,162,Poonamallee high road, chennai 600077, india |
|
|
Primary Sponsor
|
| Name |
Manisha Bala Rathy Rajadurai |
| Address |
162, poonamallee high road, velappanchavadi, chennai |
| 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 Ganesh Jeevanandan |
Saveetha dental hospital |
clinic 28, Department of pediatric and preventive dentistry
Chennai
TAMIL NADU |
9884293869
helloganz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospital 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 |
| Intervention |
AF baby file |
30 minutes |
| Comparator Agent |
h file |
30 minutes |
| Intervention |
kedo new file |
30 minutes |
| Intervention |
kedo SG blue file |
30 minutes |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1)cooperative children aged between 4 and 9 years necessitating pulpectomy in any of the primary molars diagnosed as having irreversible pulpitis 2) with no significant medical condition
3) without any antibiotic exposure in the previous two weeks
4) primary teeth with adequate coronal structure and minimum of two-thirds root structure
5) without sinus tract and pathological root resorption. |
|
| ExclusionCriteria |
| Details |
1) parents who didnt give consent
2) uncooperative child
3) Medically compromised individuals
4) teeth with root resorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in microbial count |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anti microbial count comparison between pre & post instrumentation |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
04/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this randomised controlled trial, we aimed to compare the anti microbial efficacy of root canal preparation in deciduous teeth with hand file, single rotary file system, sequential multi file system. the study assess the microbial count of various files pre instrumentation and post instrumentation. Thus it helps in selecting the best file to use for pulpectomy in deciduous teeth |