| 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
|
|
|
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
|
|
|
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. |