Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629961
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Connection and Disconnection of the Transepithelial Abutment in Dental Implants
Status:
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:
Over the past decade implant research has focused on maintaining the health and stability of peri-implant tissues A key factor is platform switching at the bone level where a narrower abutment than the implant is used This technique increases the implants horizontal surface area for biological width establishment and reduces stress on the crestal bone
Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants leading to an apical shift in the connective tissue junction and vertical tissue loss This led to the one abutment one time protocol advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing
A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection despite different treatment protocols Thus a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels This approach moves the biological width apically protecting the bone from irritation and improving marginal bone isolation
However comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking This study aims to evaluate the one abutment one time protocols effect on bone loss 12 months after prosthesis placement
Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures PROM during prosthesis fabrication and placement and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement
Throughout the prosthesis fabrication and the first 12 months various evaluations will be conducted in both abutment and Ti-base groups
Bleeding Recorded during various prosthetic stages
Pain Assessed using a visual analog scale after each stage
Anesthesia Recorded if used at each stage
Radiographs Number taken to check the fit
Time Measured for each prosthetic phase
Repetitions Number of repeated procedures quantified
Metagenomic tests Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function
Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants leading to an apical shift in the connective tissue junction and vertical tissue loss This led to the one abutment one time protocol advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing
A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection despite different treatment protocols Thus a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels This approach moves the biological width apically protecting the bone from irritation and improving marginal bone isolation
However comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking This study aims to evaluate the one abutment one time protocols effect on bone loss 12 months after prosthesis placement
Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures PROM during prosthesis fabrication and placement and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement
Throughout the prosthesis fabrication and the first 12 months various evaluations will be conducted in both abutment and Ti-base groups
Bleeding Recorded during various prosthetic stages
Pain Assessed using a visual analog scale after each stage
Anesthesia Recorded if used at each stage
Radiographs Number taken to check the fit
Time Measured for each prosthetic phase
Repetitions Number of repeated procedures quantified
Metagenomic tests Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function
Detailed Description:
None
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