Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250621
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Brief Title:
Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
Sponsor:
ASST Santi Paolo e Carlo
Organization:
ASST Santi Paolo e Carlo
Study Overview
Official Title:
Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique manual or digitally guided on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally
Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns Marginal bone level MBL measured at prosthesis installation t0 at 1 t1 2 t2 and at 3 years of follow-up visit t3 were considered MBL change from t0 to t3 was investigated The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss Two groups were considered Test Group GD for implant sites treated with a digitally guided surgery procedure Control Group FH for implants surgically placed without digitally guided surgery respectively All the procedures were performed by an experienced operator Additionally for both groups MBL changes were correlated to different supra-crestal soft tissue height STH amounts less than 3 and 3 millimeters respectively Peri-implant soft tissue parameters such as probing depth PPD modified Sulcus Bleeding Index mBI and modified Plaque Index mPI were assessed for all the restorations included
Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns Marginal bone level MBL measured at prosthesis installation t0 at 1 t1 2 t2 and at 3 years of follow-up visit t3 were considered MBL change from t0 to t3 was investigated The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss Two groups were considered Test Group GD for implant sites treated with a digitally guided surgery procedure Control Group FH for implants surgically placed without digitally guided surgery respectively All the procedures were performed by an experienced operator Additionally for both groups MBL changes were correlated to different supra-crestal soft tissue height STH amounts less than 3 and 3 millimeters respectively Peri-implant soft tissue parameters such as probing depth PPD modified Sulcus Bleeding Index mBI and modified Plaque Index mPI were assessed for all the restorations included
Detailed Description:
None
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