| CTRI Number |
CTRI/2025/03/082866 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessment of Post-Operative Pain After Different Irrigation Activation Techniques With Rotary And Reciprocating File System In Single-visit Endodontic Treatment :A CLINICAL STUDY |
|
Scientific Title of Study
|
ASSESSMENT OF POST OPERATIVE PAIN AFTER DIFFERENT IRRIGATION ACTIVATION TECHNIQUES WITH ROTARY AND RECIPROCATING FILE SYSTEM IN SINGLE VISIT ENDODONTIC TREATMENT A CLINICAL 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 |
Dr Aishwarya Nivas Patil |
| Designation |
Post Graduate Student |
| Affiliation |
School Of Dental Sciences,Krishna Vishwa Vidyapeeth Deemed to Be University |
| Address |
Department of Conservative Dentistry and Endodontics, 32 department number, School Of Dental Sciences
Krishna Vishwa Vidyapeeth
Malkapur,415 539
Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
8600929349 |
| Fax |
|
| Email |
aishwaryanpatil31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Zinge |
| Designation |
Associate Professor |
| Affiliation |
School Of Dental Sciences,Krishna Vishwa Vidyapeeth Deemed to Be University |
| Address |
Department of Conservative Dentistry and Endodontics, 32 department number, School Of Dental Sciences
Krishna Vishwa Vidyapeeth
Malkapur,415 539
Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
8310716415 |
| Fax |
|
| Email |
priyankazinge123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Nivas Patil |
| Designation |
Post Graduate Student |
| Affiliation |
School Of Dental Sciences,Krishna Vishwa Vidyapeeth Deemed to Be University |
| Address |
Department of Conservative Dentistry and Endodontics, 32 department number, School Of Dental Sciences
Krishna Vishwa Vidyapeeth
Malkapur,415 539
Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
8600929349 |
| Fax |
|
| Email |
aishwaryanpatil31@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Dental sciences, Krishna vishwa vidyapeeth, Karad,Maharashtra, India,415539 |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidyapeeth |
| Address |
Krishna Vishwa Vidyapeeth Deemed to Be University
Malkapur
karad
415539 |
| Type of Sponsor |
Private medical college |
|
|
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 Aishwarya Patil |
Krishna Vishwa Vidyapeeth |
Department of conservative dentistry and Endodontics,room number 32,School Of Dental Sciences,Malkapur,Karad 415539
Satara
MAHARASHTRA |
8600929349
aishwaryanpatil31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Krishna Vishwa Vidyapeeth Deemed To Be University,Karad |
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 |
Agitation of irrigant using PATS Vario combined with the E-Flex Rec file system for root canal cleaning. |
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the PATS Vario system combined with the E-Flex Rec file system. The route of administration is intracanal irrigation via syringe. |
| Comparator Agent |
Agitation of irrigant using PATS Vario combined with the NeoEndo Flex file system for root canal cleaning.
|
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the PATS Vario system combined with the NeoEndo Flex file system. The route of administration is intracanal irrigation via syringe.
|
| Intervention |
EndoActivator |
The irrigation solution used is Sodium Hypochlorite 3% which is chosen for its bactericidal properties and its ability to dissolve organic tissue. The EndoActivator tip is placed into the canal and vibrated at varying frequencies to produce a turbulent fluid flow. This agitation helps enhance the irrigant’s cleaning ability by removing debris dissolving tissue and reaching the apical regions of the canal. A total of 2 mL of Sodium Hypochlorite is used per canal activated for three cycles each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the EndoActivator system. The total duration of activation time is 60 seconds calculated as 20 seconds per cycle multiplied by 3 cycles. |
| Intervention |
Pro-Agitator Tip System (PATS Vario) |
The irrigation solution used is Sodium Hypochlorite 3% which is chosen for its bactericidal properties and its ability to dissolve organic tissue. The Pro-agitator tip is placed into the canal and activated to produce lateral fluid movement. This agitation helps enhance the irrigant’s cleaning ability by effectively cleaning the canal walls and removing debris. A total of 2 mL of Sodium Hypochlorite is used per canal activated for three cycles each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the Pro-agitator Tip System. The total duration of activation time is 60 seconds calculated as 20 seconds per cycle multiplied by 3 cycles. The route of administration is intracanal irrigation via syringe.
|
| Comparator Agent |
Sonic vibration of irrigant using EndoActivator combined with the E-Flex Rec file system for root canal cleaning. |
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the EndoActivator system combined with the E-Flex Rec file system. The route of administration is intracanal irrigation via syringe. |
| Comparator Agent |
Sonic vibration of irrigant using EndoActivator combined with the NeoEndo Flex file system for root canal cleaning. |
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the EndoActivator system combined with the NeoEndo Flex file system. The route of administration is intracanal irrigation via syringe. |
| Intervention |
Ultra X-Cordless Endodontic Ultrasonic Device |
The irrigation solution used is Sodium Hypochlorite 3% which is chosen for its bactericidal properties and its ability to dissolve organic tissue. The Ultra X-Cordless Endodontic Ultrasonic Device is used to activate the irrigant through ultrasonic vibrations. These vibrations create a turbulent fluid flow within the canal enhancing the irrigant’s cleaning ability by effectively cleaning the canal walls removing debris and reaching difficult areas including the apical region. A total of 2 mL of Sodium Hypochlorite is used per canal activated for three cycles each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the Ultra X-Cordless Endodontic Ultrasonic Device. The total duration of activation time is 60 seconds calculated as 20 seconds per cycle multiplied by 3 cycles. The route of administration is intracanal irrigation via syringe. |
| Comparator Agent |
Ultrasonic activation of irrigant using Ultra X-Cordless Device combined with the E-Flex Rec file system for root canal cleaning.
|
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the Ultra X-Cordless Endodontic Ultrasonic Device combined with the E-Flex Rec file system. The route of administration is intracanal irrigation via syringe. |
| Comparator Agent |
Ultrasonic activation of irrigant using Ultra X-Cordless Device combined with the NeoEndo Flex file system for root canal cleaning. |
A total of 2 mL of Sodium Hypochlorite 3% is used per canal activated for three cycles, each lasting 20 seconds. The system is activated for three cycles per canal with each cycle lasting 20 seconds. The irrigant is introduced into the canal using a syringe and activation is performed using the Ultra X-Cordless Endodontic Ultrasonic Device combined with the NeoEndo Flex file system. The route of administration is intracanal irrigation via syringe. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 and 65 years
Patients with good general health available for follow-up
Single-rooted teeth with symptomatic apical periodontitis
Willingness to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Teeth with extremely large or incompletely formed apices
Abscess or cellulitis
Complicating systemic diseases.
History of allergic reactions to irrigants
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of post-operative pain levels
Pain levels will be recorded using the Visual Analog Scale |
Post-operative pain levels assessed using the Visual Analog Scale (VAS) at 8 hours, 24 hours, and 48 hours after treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure patient satisfaction with the treatment procedure, focusing on their comfort during & after the procedure |
Patients will be asked to complete a structured survey or feedback form regarding their pain,comfort during treatment & overall satisfaction. The questionnaire will include questions on treatment comfort, post-treatment pain, & overall experience, rated on a Likert scale (e.g., 1–5, with 1 being very dissatisfied & 5 being very satisfied). after one week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title of Study:
Assessment of Post-Operative Pain After Different Irrigation Activation Techniques with Rotary and Reciprocating File Systems in Single-Visit Endodontic Treatment: A Clinical Study. Study Objective:
The objective of this study is to evaluate and compare the post-operative pain levels experienced by patients undergoing single-visit endodontic treatments using different irrigation activation techniques (Pro-agitator Tip System (PATS), EndoActivator, Ultra X-Cordless Endodontic Ultrasonic Device) in combination with rotary and reciprocating file systems (E-Flex Rec and NeoEndo Flex). Study Design:
This is an in vivo, randomized, stratified, parallel clinical trial. A total of 90 patients will be enrolled and randomly assigned to six treatment groups (15 patients per group). Each group will receive one combination of irrigation activation technique and file system. Inclusion Criteria: - Patients aged between 18 and 65 years.
- Patients with symptomatic apical periodontitis requiring single-visit endodontic treatment on single-rooted teeth.
- Patients willing to provide informed consent and available for follow-up.
Exclusion Criteria: - Teeth with large (>5mm) periapical lesions, history of RCT, abscess, cellulitis, or complicating systemic diseases.
- Patients with allergies to any of the materials or irrigants used in the study.
Interventions: - Group 1: PATS Vario with NeoEndo Flex File System.
- Group 2: PATS Vario with E-Flex Rec File System.
- Group 3: EndoActivator with NeoEndo Flex File System.
- Group 4: EndoActivator with E-Flex Rec File System.
- Group 5: Ultra X-Cordless Endodontic Ultrasonic Device with NeoEndo Flex File System.
- Group 6: Ultra X-Cordless Endodontic Ultrasonic Device with E-Flex Rec File System.
Primary Outcome:
Post-operative pain levels assessed using the Visual Analog Scale (VAS) at 8 hours, 24 hours, and 48 hours after treatment. |