| CTRI Number |
CTRI/2024/08/072514 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Checking the root canal after cleaning using different root canal instruments |
|
Scientific Title of Study
|
Evaluation of efficacy of trunatomy needle irrigation, smartlite pro endoactivator and laser activated irrigation in reduction of microbial load during root canal treatment using endocator:A Randomized controlled 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 |
Purushothapatnapu Komala Sai Supriya |
| Designation |
Postgraduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Sibar Institute of Dental Sciences
Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7382087999 |
| Fax |
|
| Email |
komalasupriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Purushothapatnapu Komala Sai Supriya |
| Designation |
Postgraduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Sibar Institute of Dental Sciences
Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7382087999 |
| Fax |
|
| Email |
komalasupriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayesh Vemuri |
| Designation |
Professor and Head of the department |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Sibar Institute of Dental Sciences
Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9912603960 |
| Fax |
|
| Email |
drvsayeshendo@sids.ac.in |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences
Takkellapadu
Guntur
Pin code 522509
Andhra Pradesh
India |
|
|
Primary Sponsor
|
| Name |
P Komala Sai Supriya |
| Address |
Department of Conservative Dentistry and Endodontics
Sibar Institute of Dental Sciences
Takkellapadu
Guntur |
| 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 P Komala Sai Supriya |
Sibar Institute of Dental Sciences |
Room Number 5
Department of Conservative dentistry and Endodontics Takkellapadu
Guntur
Pincode 522509
Andhrapradesh
India
Guntur
ANDHRA PRADESH |
7382087999
komalasupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sibar Institute of Dental Sciences Guntur |
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 |
| Comparator Agent |
Smart Lite Pro Endo activator and
Diode laser
|
Evaluation of efficacy of Activation of root canal irrigants with Smart Lite Pro Endo activator and Diode laser after biomechanical preparation (at 30 minutes during root canal treatment) and after irrigation with Smart Lite Pro Endo activator and Diode laser(at 45 minutes during root canal treatment)with a frequency of sampling twice during root canal treatment and with a total duration of 60 minutes of root canal procedure
|
| Intervention |
Trunatomy needle |
Evaluation of efficacy of Activation of root canal irrigants with Trunatomy needle using ATP testing method after biomechanical preparation (at 30 minutes during root canal treatment) and after trunatomy needle irrigation (at 45 minutes during root canal treatment) with a frequency of sampling twice during root canal treatment and with a total duration of 60 minutes of root canal procedure
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Teeth diagnosed with pulp necrosis in relation to multirooted maxillary and mandibular teeth
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
Teeth with open apices and evidence of resorption and those indicated for surgery
Teeth with fractures and cases diagnosed with irreversible pulpitis
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial load evaluation after irrigation using Trunatomy needle Smart lite pro endoactivator and Diode laser |
Microbial load evaluation using ATP testing method at 45 minutes during root canal treatment (after irrigation using Trunatomy needle Smart lite pro endoactivator and Diode laser protocol) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Microbial load evaluation using ATP testing method after Biochemical preparation |
Microbial load evaluation using ATP testing method at 30 minutes during root canal treatment (after Biochemical preparation) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="1"
Months="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The goal of endodontic treatment is to eliminate the pathogenic effects of bacteria in the root canal system of the teeth. Treatment approaches include chemomechanical cleaning and filling to prevent the microorganisms from infecting and reinfecting the canals and the periradicular tissues after treatment Many irrigation devices have been developed to improve the irrigant delivery throughout the root canal by using sonic or ultrasonic energy. Recently, SLP endoactivator was introduced. It consists of an ergonomic, cordless, contrangled sonic motor that works at 3000 cpm and 18000 cpm. Diode lasers exhibit high water transmission, that allows them to interact with the microorganisms located in the deeper layers of dentinal tubules.A recent study showed that 940nm diode laser has extremely high bactericidal effect on Enterococcus faecalis. Trunatomy needle is a double side vented needle that provides a balanced volume of irrigation solution for greater control throughout the canal .Adenosine Triphosphate is the universal energy carrier in all living systems mediating intracellular energy transfer and enabling cells to store and transport chemical energy. Endocator is the chair side technique to assess the microbial load in the root canal system during endodontic treatment. Bioluminescent ATP assays takes advantage of firefly luciferase enzymatic reaction, that uses ATP from viable cells to generate the photons of light. Present study is to evaluate the effectiveness of three different irrigation activation mechanisms, trunatomy needle irrigation, SLP endoactivator and laser diode in disinfecting the root canals during root canal treatment using Endocator. A total of 150 patients will be recruited according to the inclusion criteria, from the out patient department and after taking the informed consent, treatment protocols will be performed after randomization using Sequentially Numbered Opaque Sealed Envelope (SNOSE) method. Microbial load in the root canal will be evalauted using ATP testing method (Endocator). |