| CTRI Number |
CTRI/2024/08/072514 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2026 |
| 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)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2024 |
| Date of Study Completion (India) |
26/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="5" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 were recruited
according to the inclusion criteria, from the outpatient department and after
taking the informed consent, treatment protocols were performed after
randomization using Sequentially Numbered Opaque Sealed Envelope (SNOSE)
method. Microbial load in the root canal was evalauted using ATP testing method
(Endocator). Present in vivo study evaluated antimicrobial
efficacy of three different irrigation activation techniques—CNI using TN, SA using
SLP-EA, and LAI using 980 nm DL in reducing microbial load of pulp necrosis.
Microbial reduction is quantitatively assessed using ATP-based bioluminescence
assay serving as reliable indicator of viable bacterial activity within canal. A
cohort of 150 patients with multirooted maxillary and mandibular teeth of pulp
necrosis are included and randomly allocated into three groups (n = 50 each)
using SNOSE technique. Standardized BMP is performed using ProTaper Ultimate
rotary files, followed by irrigation and activation using 2 ml of 5.25% NaOCl
for 2 minutes followed by 1 ml of 17% EDTA for 1 minute and 2 ml of 5.25% NaOCl
for 2 minutes. ATP readings are recorded post instrumentation and post
irrigation to evaluate reduction in microbial activity. Evidence demonstrated
that all three irrigation techniques resulted in a substantial reduction in ATP
levels from post-instrumentation to post-irrigation stages (p < .001), confirming effectiveness
of irrigation. However, intergroup
analysis showed notable differences in efficacy among techniques. DL group
exhibited lowest post-irrigation ATP values, followed by SLP-EA group, while TN
group showed comparatively higher residual ATP levels. Mean percentage
reduction in ATP values is highest in DL group (93.06%), followed by SLP-EA group
(88.00%), and least in TN group (74.63%). Statistical
analysis using ANOVA and post hoc tests revealed significant differences
between TN and SLP-EA groups, as well as between TN and DL groups (p < .05), indicating superior
antimicrobial efficacy of activation techniques over CNI. However, no
statistically significant difference is observed between SLP- EA and DL groups
(p > .05), suggesting comparable
effectiveness between these two advanced irrigation techniques. Findings
highlight importance of irrigant activation in enhancing disinfection,
particularly in complex anatomical regions such as apical thirds, isthmuses,
and lateral canals, where CNI may be less effective. Superior
performance of DL may result from its photothermal and photomechanical effects
enhancing bacterial elimination and improving penetration of irrigants into
dentinal tubules. Similarly, effectiveness of SA using SLP-EA can be explained
by acoustic streaming and cavitation effects promoting better irrigant flow and
disruption of biofilms. Despite enhanced
efficacy of DL, lack of statistically significant difference between DL and
SLP-EA suggests that SA can serve as a clinically viable and cost-effective
alternative to laser systems.
Therefore it can be
concluded that ATP Endocator can be considered as a reliable chairside tool in
assessing microbial load of root canal system. |