Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358833
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-07
Brief Title:
Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems
Sponsor:
Qassim University
Organization:
Qassim University
Study Overview
Official Title:
Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation A Randomized Controlled Pragmatic Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Summary
After a root canal procedure it is common to experience postoperative pain Cleaning the root canal thoroughly is crucial for pain relief but removing all debris with standard methods is difficult Irrigation using either traditional endodontic needles or newer methods like endodontic activation helps clean the canal This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation the Endo1 device EA and the conventional endodontic needles EN The study will provide insights into which method is more effective in reducing postoperative pain
After a root canal procedure it is common to experience postoperative pain Cleaning the root canal thoroughly is crucial for pain relief but removing all debris with standard methods is difficult Irrigation using either traditional endodontic needles or newer methods like endodontic activation helps clean the canal This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation the Endo1 device EA and the conventional endodontic needles EN The study will provide insights into which method is more effective in reducing postoperative pain
Detailed Description:
Background
One of the primary objectives following root canal therapy is to alleviate pain While postoperative pain is undesirable it is often considered a common sensation following endodontic treatment
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task even when using precise rotary hand or hybrid instruments Therefore irrigation plays a crucial role in the cleaning and shaping process
Traditional root canal irrigation typically involves the use of an endodontic needle EN to disinfect the root canal However a newer approach called endodontic activation EA has been suggested to enhance root canal disinfection by activating irrigants within the canal
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment
Rationale
No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device Guilin Woodpecker Guilin China on postoperative pain using a pragmatic approach Therefore the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation
Study objectives
The study aims to assess and compare the levels of postoperative pain following endodontic activation EA of irrigants using the Endo1 Ultrasonic Endo Activate Device Guilin Woodpecker Guilin China versus conventional endodontic needle EN irrigation in root canal therapy
Methods In this prospective single-blind parallel-armed randomized clinical trial standard root canal preparation will be done patients will be randomly assigned into one of the two groups In the final irrigation protocol group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique
One of the primary objectives following root canal therapy is to alleviate pain While postoperative pain is undesirable it is often considered a common sensation following endodontic treatment
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task even when using precise rotary hand or hybrid instruments Therefore irrigation plays a crucial role in the cleaning and shaping process
Traditional root canal irrigation typically involves the use of an endodontic needle EN to disinfect the root canal However a newer approach called endodontic activation EA has been suggested to enhance root canal disinfection by activating irrigants within the canal
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment
Rationale
No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device Guilin Woodpecker Guilin China on postoperative pain using a pragmatic approach Therefore the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation
Study objectives
The study aims to assess and compare the levels of postoperative pain following endodontic activation EA of irrigants using the Endo1 Ultrasonic Endo Activate Device Guilin Woodpecker Guilin China versus conventional endodontic needle EN irrigation in root canal therapy
Methods In this prospective single-blind parallel-armed randomized clinical trial standard root canal preparation will be done patients will be randomly assigned into one of the two groups In the final irrigation protocol group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None