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CTRI Number  CTRI/2023/05/052543 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 21/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of pain after single visit root canal treatment 
Scientific Title of Study   Comparative evaluation of postoperative pain after single visit endodontic treatment using Neolix neoniti and E3 Azure file system -A randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha Dhananjay Raysad 
Designation  Postgraduate student 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 7, Department of Conservative Dentistry and Endodontics, second floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010

Belgaum
KARNATAKA
590010
India 
Phone  9535428250  
Fax    
Email  dhananjaydishadr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Disha Dhananjay Raysad 
Designation  Postgraduate student 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 7, Department of Conservative Dentistry and Endodontics, second floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010


KARNATAKA
590010
India 
Phone  9535428250  
Fax    
Email  dhananjaydishadr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonal B Joshi 
Designation  Professor and Dean 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department number 7, Department of Conservative Dentistry and Endodontics, second floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448141278  
Fax    
Email  jsonal70@yahoo.co.in  
 
Source of Monetary or Material Support  
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
 
Primary Sponsor  
Name  Disha Dhananjay Raysad 
Address  Department number 7, Department of Conservative Dentistry and Endodontics, second floor, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar Belgaum KARNATAKA 590010 
Type of Sponsor  Other [[self funded]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Disha Dhananjay Raysad  KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar   Department number 7, Department of Conservative Dentistry and Endodontics, second floor.
Belgaum
KARNATAKA 
09535428250

dhananjaydishadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  E3 Azure   Apical diameter of 0.25mm,6% Taper,Instrumentation according to manufacturers instruction 
Intervention  Neolix Neoniti  Apical diameter of 0.25mm,6% Taper,Instrumentation according to manufacturers instruction 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA
1.Patients requiring root canal treatment of maxillary premolar teeth with two root canals, diagnosed clinically as asymptomatic irreversible pulpitis using pulp sensitivity tests.
2.Patients ranging in the age group of 18-50 years.
3.Patients with non-contributory medical history.
4.Teeth with no pre-operative pain
5.Teeth with adequate coronal structure to ascertain proper isolation.

 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA: -
PATIENT SPECIFIC:
1.Patients who refuse to consent for the procedure.
2.Patients with any systemic diseases, pregnancy or immuno - compromised conditions.
3.Patients on any antibiotic therapy in the past 3 months
4.Patients on any analgesic drugs in the past 7 days
5.Patients allergic to lignocaine in 1:80,000 concentration adrenaline
6.Patients allergic to Ibuprofen
7.Patients requiring root canal treatment of two or more teeth ipsilaterally (since the pain
caused by any of these teeth can result in false positive reading)

SPECIFIC TO DIAGNOSIS:
1.Teeth with acute apical periodontitis
2.Teeth with acute periapical abscess
3.Teeth with periapical radiolucency of diameter greater than0.5 cm (5 mm)
4.Teeth with an inflammatory exudate draining through the canal.
5.Necrotic painful teeth with absence of sinus tract for drainage
6.Re-treatment cases
7.Dilacerated teeth
8.Teeth with aggressive periodontitis or grade III mobility



TOOTH SPECIFIC:
1.Teeth with calcified canals, immature apex and internal and external resorption.
2.Two root canals ending with a single apical foramen.
3.Severe labially or lingually malpositioned teeth in which obtaining straight-line access is difficult.
4.If a #10 K-file is very resistant to movement or if a #20 K-file easily goes to length, then teeth with such canals will be excluded (apical gauging).

 
 
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 
To evaluate and compare the incidence and intensity of post-operative pain after single visit endodontic treatment using Neolix Neoniti and E3 Azure file system at 6, 24, 48 and 72 hours using Visual Analogue Scale  6, 24, 48 and 72 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the association of variables (age and sex) between groups
 
6, 24, 48 and 72 hours  
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) 21/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

·         BACKGROUND OF STUDY:

 

·         Single visit endodontic treatment has gained preference over multiple visit endodontic due to advantages such as decreased number of operative procedures and no risk of inter-appointment leakage of the temporary restoration, and its economical.

·         There is an exponential growth in field of instrumentation to treat complexity of canal, great amount of research is been undertaken regarding the materials of file system and their manufacturing procedures.

·         Neolix neoniti and E3 Azure file system both are extremely flexible and resistant to breakage. However, they are made from different technology and have different cross sections. Both of these instruments are responsible in very big way for causing extrusion of debris which is normally seen phenomenon with any instrument used with any technique

·         So, this kind of extrusion of debris  which is one of the main causative factors for post operative pain that instrument which cause minimal extrusion becomes prudent as it causes less pain

·         Invitro study done on Neolix neoniti claimed to have decreased apical debris extrusion Whereas in vivo study done on E3 Azure with and without maintaining apical patency did not show significant post operative pain thus it leads to aim of study

 

·         PURPOSE:

 

·         To evaluate and compare incidence and intensity of the post - operative pain after single visit endodontic treatment using Neolix neoniti and E3 Azure file systems.

·         To evaluate and compare the time required for instrumentation of canals in both groups.

·         To evaluate and compare the association of variables (age and sex) between groups.

 

 

 
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