| CTRI Number |
CTRI/2024/11/076701 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing how eefectiv two new file systems are, that is ProTaper Ultimate and ProTaper next in their ability to remove bacterial load from infected root canals. |
|
Scientific Title of Study
|
Comparative study on bacterial load reduction from primarily infected root canals using two rotary file systems Protaper ultimate and Protaper next- A randomized 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 |
Supriya Kumari |
| Designation |
Post graduate student |
| Affiliation |
Bapuji Educational Association (BEA) |
| Address |
Room number 6
Bapuji Dental College and Hospital, MCC B block, Davanagere
Room number 6
Bapuji Dental College and Hospital, MCC B block, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
7022867361 |
| Fax |
|
| Email |
Supriyakumaridr1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi NC |
| Designation |
Professor and guide |
| Affiliation |
Bapuji Dental College and Hospital, Davangere |
| Address |
Room number 6
Bapuji Dental College and Hospital MCC B block, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
7022867361 |
| Fax |
|
| Email |
Supriyakumaridr123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi NC |
| Designation |
Professor and guide |
| Affiliation |
Bapuji Dental College and Hospital, Davangere |
| Address |
Room number 6
Bapuji Dental College and Hospital MCC B block, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
7022867361 |
| Fax |
|
| Email |
Supriyakumaridr123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number6, Bapuji Dental College and Hospital, MCC B block, Davangere, 577004 |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Kumari |
| Address |
Room number 6, Bapuji Dental College and Hospital, MCC B block, Davangere, 577004 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Supriya Kumari |
Room number6, Bapuji Dental College and Hospital, MCC B block, Davangere, 577004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Kumari |
Bapuji Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Room number 6, Bapuji Dental College and Hospital, MCC B block, Davangere, 577004
Davanagere
KARNATAKA |
7022867361
Supriyakumaridr1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bapuji Dental College and Hospital Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients diagnosed with pulp necrosis and needing root canal therapy. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Protaper next |
Rotary endodontic files used for cleaning and shaping of infected root canals. |
| Intervention |
Protaper ultimate rotary files |
Newly introduced rotary endodontic files used for cleaning and shaping of infected root canals. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
1) Primarily infected maxillary and mandibular premolars with single root and single
canal requiring endodontic treatment.
2)Systemically healthy patients (ASA-I and II) between the age group of 35-44 years.
|
|
| ExclusionCriteria |
| Details |
1) Grossly decayed teeth that could not be isolated with rubber dam.
2) Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or
obliterated).
3) Teeth associated with soft tissue abscess or swelling.
4) Teeth with external and internal root resorption.
5) Teeth with open apex.
6) Gingival pockets of more than 4mm.
7) Patients who received antibiotics within 3 months.
8) Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the bacterial load reduction in primarily infected root canal using
ProTaper Ultimate file system.
2) To assess the bacterial load reduction in primarily infected root canal using
GenEndo file system.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the bacterial load reduction in primarily infected root canal using
ProTaper Ultimate and GenEndo file systems. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is a randomized clinical trial with a total sample size of 28 subjects. Patients diagnosed with pulp necrosis in single rooted lower premolars will be taken in the study and the bacterial load reduction of two files will be compared. One file is newly launched which is protaper ultimate and it will be compared to protaper next. Bacterial load reduction ability of files will be based on total reduction of colony forming unit before and after instrumentation of the canal. |