Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554080
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-10
Brief Title:
Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Survival and Success Rates of External- and Internal- Connection Dental Implants Placed Within the United Kingdom Armed Forces
Status:
ACTIVE_NOT_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 is a retrospective cohort study that evaluates the survival Outcome 1 of dental implant systems external connection Cohort 1 and internal connection Cohort 2 and the effectiveness of maintaining crestal bone levels Outcome 2 placed within United Kingdom Armed Forces personnel The secondary objectives include assessment of block bone grafting on outcome assessment of restoration bridge vs crown on outcome and assessment of placement technique immediate early delayed placement Inclusion criteria all military patients that received dental implants since 2014-2024 Exclusion criteria military patients that have not received radiographic review or follow-up of the dental implant or who have left service or have a follow-up that is less than 12-months post placement of the dental implant
Detailed Description:
Dental care to the United Kingdom Armed Forces UKAF is provided by Defence Primary Healthcare DPHC Dental which incorporates a Managed Clinical Network MCN to co-ordinate and treat complex restorative cases referred by general dental practitioners GDPs with a central hub at the DCRD The DCRD routinely employs dental implants within patients rehabilitative treatment pathways
Nobel Biocare are the sole provider of dental implants to DPHC with three-systems Nobel Speedy Groovy Nobel Active and Nobel Parallel routinely employed Of the three systems Nobel Speedy Groovy have been in use for over 20-years employing an external hexagon prosthet-ic connection EH With EH the microbiological junction lies at the vertical junction of the abutment and implant Platform-Matched P-M Subsequently a 1mm zone of inflammation occurs around this junction with associated crestal bone loss The establishment of crestal bone levels at the first thread of the implant was within the parameters of implant success In contrast Nobel Active and Parallel systems employ an internal conical connection CC that facilitates a platform-switching P-S approach to restoration of the implant The platform switching concept aims to move the microbiological junction to the horizontal coronal surface of the implant away from the implant alveolar junction with the aim of preserving vertical crestal bone to the full height of the implant This study aims to evaluate whether platform-switching influences dental implant survival primary outcome and radiographic bone levels secondary outcome
The study aims to account for the following factors on the outcome measures dental implant pathway protocol immediately- early- delayed- or late-placement protocols post extraction bone grafting to facilitate implant provision either undertaken either prior to- or during- implant placement block grafting sinus floor elevation augmentation at time of placement and restoration type crown bridge over-denture support
Nobel Biocare are the sole provider of dental implants to DPHC with three-systems Nobel Speedy Groovy Nobel Active and Nobel Parallel routinely employed Of the three systems Nobel Speedy Groovy have been in use for over 20-years employing an external hexagon prosthet-ic connection EH With EH the microbiological junction lies at the vertical junction of the abutment and implant Platform-Matched P-M Subsequently a 1mm zone of inflammation occurs around this junction with associated crestal bone loss The establishment of crestal bone levels at the first thread of the implant was within the parameters of implant success In contrast Nobel Active and Parallel systems employ an internal conical connection CC that facilitates a platform-switching P-S approach to restoration of the implant The platform switching concept aims to move the microbiological junction to the horizontal coronal surface of the implant away from the implant alveolar junction with the aim of preserving vertical crestal bone to the full height of the implant This study aims to evaluate whether platform-switching influences dental implant survival primary outcome and radiographic bone levels secondary outcome
The study aims to account for the following factors on the outcome measures dental implant pathway protocol immediately- early- delayed- or late-placement protocols post extraction bone grafting to facilitate implant provision either undertaken either prior to- or during- implant placement block grafting sinus floor elevation augmentation at time of placement and restoration type crown bridge over-denture support
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