Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518304
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Effectiveness of GentleWave System in Endodontic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial Effectiveness of GentleWave System in Endodontic Treatment and Its Impact on Reducing Post- Operative Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy of the GentleWave System compared to conventional methods in reducing postoperative pain in patients with necrotic pulp or requiring endodontic retreatment
Detailed Description:
New irrigation modalities such as the GentleWave System which integrates advanced multisonic ultrasound technology have been developed to overcome limitations and improve root canal treatments success rates by ensuring comprehensive cleaning while minimizing mechanical instrumentation This system featuring CleanFlow technology optimizes the delivery of irrigants and promotes efficient root canal debridement Postoperative pain is common usually peaking within the first 24 hours after treatment and decreasing thereafter
In the presence of necrosis microorganisms can colonize anatomical complexities such as isthmuses ramifications and dentinal tubules causing symptoms such as pain inflammation and in some cases even odontogenic sinusitis Conventional Syringe Irrigation CSI which delivers irrigants NaOCl EDTA through a needle-syringe system often fails to reach the entire working length and the intricate anatomy of the root canal This inadequacy can result in residual bacteria and necrotic tissue potentially compromising treatment efficacy and increasing the risk of treatment failure furthermore positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex leading to complications
In the presence of necrosis microorganisms can colonize anatomical complexities such as isthmuses ramifications and dentinal tubules causing symptoms such as pain inflammation and in some cases even odontogenic sinusitis Conventional Syringe Irrigation CSI which delivers irrigants NaOCl EDTA through a needle-syringe system often fails to reach the entire working length and the intricate anatomy of the root canal This inadequacy can result in residual bacteria and necrotic tissue potentially compromising treatment efficacy and increasing the risk of treatment failure furthermore positive pressure exerted during CSI may cause the extrusion of irrigants beyond the apex leading to complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None