Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651502
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Efficacy of a Dental Implant System for Immediate Restoration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The primary objective of this study is to observe the performance of an implant system with a new surface EK III NH dental implants over a period of two years The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration The investigators will document the performance of the implants through regular dental check-ups and X-rays
Detailed Description:
Treating patients with missing teeth using dental implants is now a common and reliable approach in modern dentistry Significant improvement has been made in implant shape design implant surface optimization and surgical techniques to ensure predictable bonding between the titanium implants and bone osseointegration Modern implants are designed to be stable both immediately after placement primary stability and over time as they bond with the bone secondary stability Factors such as the quality and quantity of the patients bone the design of the implant and the surgical technique used can all affect primary stability The implants secondary stability is affected by many of these same factors but has also been demonstrated to be influenced by other patient-related factors including wound site blood supply as well as the surface of the implants Various surface treatments like titanium plasma spraying acid etching hydroxyapatite coating and sandblasting have been developed to improve this bond secondary stability For instance porous coatings can help by allowing the bone to grow into the implant while hydroxyapatite coatings are biocompatible and encourage bone formation Research has shown that different surface treatments can lead to different cellular responses affecting how bone cells osteoblasts behave and develop around the implant
In clinical practice several methods are used to measure how stable an implant is immediately after placement known as primary stability These methods include measuring the insertion torque and using resonance frequency analysis RFA To assess secondary stability or osseointegration which refers to the long-term bonding of the implant to the bone various techniques are used These include RFA mechanical disruption testing and histomorphometric analysis Additionally changes in the bone level around the implant are commonly observed through X-rays as a non-invasive way to monitor the long-term success of dental implants Human histological evidence of successfully osseointegrated implants is extremely rare in the literature because there are few opportunities to retrieve implants in humans
Hiossen is a leading and rapidly growing implant manufacturer with its systems used in over 70 countries Recently the company launched a new implant system called EK III NH This system features a sand-blasted and acid-etched SA surface with a nano-hydroxyapatite NH coating This special surface allows for faster bone healing and reduces the time before the implant can be loaded compared to other types of implant surfaces The companys internal studies have shown that this surface treatment creates a very thin coating layer on the implant that is hydrophilic meaning it attracts water which improves the bonding process with 30 higher osseointegration than conventional SA surfaces In addition the new EK III NH system includes design improvements compared to the current ET SA implant system by the same company New features include a buttress thread 09 mm pitch reverse helical cutting edge and an improved internal hex connection making the system easier to achieve good mechanical bonding immediately primary stability and easier to restore
The investigators propose conducting a short-term clinical study to examine how well the bone around the EK III NH implants is maintained when they are immediately restored with a temporary crown This study aims to assess the benefits of using the EK III NH implants in dental treatments
In clinical practice several methods are used to measure how stable an implant is immediately after placement known as primary stability These methods include measuring the insertion torque and using resonance frequency analysis RFA To assess secondary stability or osseointegration which refers to the long-term bonding of the implant to the bone various techniques are used These include RFA mechanical disruption testing and histomorphometric analysis Additionally changes in the bone level around the implant are commonly observed through X-rays as a non-invasive way to monitor the long-term success of dental implants Human histological evidence of successfully osseointegrated implants is extremely rare in the literature because there are few opportunities to retrieve implants in humans
Hiossen is a leading and rapidly growing implant manufacturer with its systems used in over 70 countries Recently the company launched a new implant system called EK III NH This system features a sand-blasted and acid-etched SA surface with a nano-hydroxyapatite NH coating This special surface allows for faster bone healing and reduces the time before the implant can be loaded compared to other types of implant surfaces The companys internal studies have shown that this surface treatment creates a very thin coating layer on the implant that is hydrophilic meaning it attracts water which improves the bonding process with 30 higher osseointegration than conventional SA surfaces In addition the new EK III NH system includes design improvements compared to the current ET SA implant system by the same company New features include a buttress thread 09 mm pitch reverse helical cutting edge and an improved internal hex connection making the system easier to achieve good mechanical bonding immediately primary stability and easier to restore
The investigators propose conducting a short-term clinical study to examine how well the bone around the EK III NH implants is maintained when they are immediately restored with a temporary crown This study aims to assess the benefits of using the EK III NH implants in dental treatments
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