Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182670
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2023-12-10
Brief Title:
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study Overview
Official Title:
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement 12-months Parallel Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
NABUT
Brief Summary:
The present randomized controlled trial aims to assess the influence of a new prosthodontics device Gingival Former Abutment -GFA on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement
The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA
Clinical and radiographic examination will be performed at implant placement surgery prosthetic load 6 and 12 months follow-up
The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA
Clinical and radiographic examination will be performed at implant placement surgery prosthetic load 6 and 12 months follow-up
Detailed Description:
According to current literature physiological bone loss around oral implants is expected after placement and load 1 mm during the first year and 02 mm each subsequent year Different implant designs and surgical protocols have been tested to minimize bone resorption and subcrestal implant placement partially seems to overcome this issue However if this procedure increases the length of the transmucosal tunnel increasing the risk of peri-implant soft tissue infection
The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel The GFA follows the one abutment one time concept which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures Our objective is to validate or deny this claim
The study is a monocentric pragmatic single-blinded randomized clinical trial RCT of parallel design The trial will have a one-year duration with data collection at the surgical phase at implant load and 6 and 12 months after load The primary outcome will be radiographical MBL marginal bone level changes around the implant Secondary outcomes will be the assessment of the peri-implant soft tissues
The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel The GFA follows the one abutment one time concept which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures Our objective is to validate or deny this claim
The study is a monocentric pragmatic single-blinded randomized clinical trial RCT of parallel design The trial will have a one-year duration with data collection at the surgical phase at implant load and 6 and 12 months after load The primary outcome will be radiographical MBL marginal bone level changes around the implant Secondary outcomes will be the assessment of the peri-implant soft tissues
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