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CTRI Number  CTRI/2024/04/065586 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing depth of penetration of irrigating solution during root canal treatment using different irrigation systems  
Scientific Title of Study   comparative evaluation of efficacy of endodontic irrigant delivery to working length using different irrigant activation techniques-an in vivo study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaspreet Kaur 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital,Patiala 
Address  Department of conservative dentistry and Endodontics, room no 4, second floor, Government Dental College and Hospital, Patiala. ,

Patiala
PUNJAB
147001
India 
Phone  9116338455  
Fax    
Email  jaspreet0997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jaspreet Kaur 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital,Patiala 
Address  Department of conservative dentistry and Endodontics, room no 4, second floor, Government Dental College and Hospital, Patiala

Patiala
PUNJAB
147001
India 
Phone  9116338455  
Fax    
Email  jaspreet0997@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Navjot Singh Khurana 
Designation  Assistant Professor 
Affiliation  Government Dental College and Hospital, Patiala 
Address  Department of conservative dentistry and Endodontics, room no 4, second floor, Government Dental College and Hospital, Patiala

Patiala
PUNJAB
147001
India 
Phone  9501345566  
Fax    
Email  navjot71@gmail.com  
 
Source of Monetary or Material Support  
government dental college and hospital,patiala 
 
Primary Sponsor  
Name  Jaspreet Kaur 
Address  H/ No: 4c, Near post office, New lal bagh colony, Patiala, Punjab. PIN : 147001 
Type of Sponsor  Other [Self] 
 
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 
Dr Jaspreet Kaur  government dental college and hospital ,patiala  Department of Conservative Dentistry and Endodontics, room no 4, second floor, Government Dental College and Hospital, Patiala
Patiala
PUNJAB 
9116338455

jaspreet0997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional needle syringe irrigation using 30 gauge side vented needle   30 gauge side vented needle will be placed 2mm short of working length. canal will be irrigated with 2ml of radiographic dye. 
Intervention  endoactivator  In this group agitation of radiographic contrast medium will be performed using an endoactivator. The tip of endoactivator will be placed 2mm short of working length and radiographic dye will be activated at 10,000 cpm for 60 seconds.  
Intervention  endovac irrigation system  after canal preperation till 35 4% ,2ml of radiographic dye will be delivered in the pulp chamber and suctioned with a macrocannula at the middle third of root canal and then microcannula will be placed at working length 
Intervention  manual dynamic agitation with well fitted gp cone  after preparing the mesiobuccal canal till 35 4% and irrigating the canal with radiographic dye,a well fitted gp cone will be held by tweezer grasped short of working length and manual agitation will be done with 2mm amplitude at frequency of 100 strokes for 1 minute. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Mandibular first permanent molar with completely formed roots, intact mesial root with 2 canals.

Teeth having sufficient tooth structure to allow the placement of rubber dam.
 
 
ExclusionCriteria 
Details  a-radiographic evidence of periapical radiolucent lesion and external root resorption
b- calcified canals on radiograph
c- incompletely formed roots.
d- anatomic variations such as extremely curved canals.
e- apparently, narrow roots in which apical preparation with #35 file would be overzealous.
f- patient allergic to anything used in this procedure especially rubber dam material and radiographic contrast media.
g- medically unfit patients.
h- pregnant patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
with the contrast media inside the canal, a digital image for each tooth will be taken and the difference between working length and maximum irrigant penetration will then be measured and evaluated on rvg software.
the group in which contrast media is closest to working length will be better. 
at the same time when the study is done. 
 
Secondary Outcome  
Outcome  TimePoints 
improved debridement of root canals in groups where the radiopaque dye has penetrated closest to the working length   at the same time when the study is done 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/04/2024 
Date of Study Completion (India) 17/03/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM

           To determine and compare the delivery of irrigating solution (depth of penetration) to the working length using the conventional needle syringe, manual dynamic agitation, endovac, and endo activator.

MATERIALS AND METHODS

            A total of 80 patients, in the range of 20 -40 yrs, irrespective of gender,   requiring root canal treatment mandibular first permanent molars will be randomly selected after taking informed consent. After access opening and working length determination, all mesiobuccal canals will be sequentially prepared with Hyflex CM  rotary files to size 35/.04. The prepared mesiobuccal canals will then be assigned into 4 different groups of 20 each for evaluation of irrigant delivery using radiographic dye.

Group 1- Conventional needle syringe irrigation 

Group 2- Manual Dynamic Agitation with well-fitted GP cone

Group 3- EndoVac irrigation system 

Group 4- Endoactivator 

With the contrast media inside the canal, a digital image for each tooth will be taken and the difference between working length and maximum irrigant penetration will then  be measured and evaluated on RVG software.

PROCEDURE FOR MAKING RADIOGRAPHIC CONTRAST MEDIA-

A  sterile intravascular contrast medium containing iodine (Diatrizoate meglumine and Diatrizoate sodium) TRAZOGRAF 76% will be mixed with 5% sodium hypochlorite in the ratio of 45:55 to have an irrigating solution with a viscosity and surface tension similar to 5% sodium hypochlorite.



CLINICAL IMPLICATION

Successful endodontic therapy depends on the complete elimination of necrotic pulp, microorganisms, and debris from the root canal system. Efficient irrigation techniques should be able to completely debride the root canal system by delivering the irrigant to reach the entire working length. Newer irrigation techniques appear to have resulted in improved canal cleanliness when compared with conventional needle irrigation. Apical vapor lock effect hinders irrigants from penetrating the apical third of the root canals. Elimination of apical vapor lock may be achieved by activation of the irrigant by various methods like manual dynamic agitation, sonic or ultrasonic agitation. The apical negative pressure technique is another effective method to eliminate apical vapor lock. Endovac not only avoids air entrapment but is also able to deliver irrigants to working length without causing their undue extrusion to periapex. These techniques significantly increase the success rate of root canal treatment and improve the long-term prognosis of the tooth.


 
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