Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
Study NCT ID:
NCT02953392
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2016-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Different Transcrestal Sinus Floor Elevation
Sponsor:
NYU College of Dentistry
Organization:
Study Overview
Official Title:
Evaluation of Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Two Different Transcrestal Sinus Floor Elevation Approaches: A Multi-Center, Double Blind, Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus floor elevation technique to insert one implant will be selected. The purpose of this multi-center, prospective, double blind, and randomized investigation is to analyze a platform switched implant when placed at limited maxillary residual bone height with low bone density compared to a platform matching implant with or without bone graft material.
Detailed Description:
Approximately 60 subjects who require at least one posterior maxilla implant in the areas of the second pre-molars or (first or second) molars with 6 to 9 mm of crestal bone below the sinus floor, as determined on the computerized axial tomographic (CT) scan, will be recruited for the study. Subjects will receive dental implants to replace a missing tooth (second pre-molar or first/second molar) on one side of the maxillary arch. Each subject will receive one type of implant: platform switched (PS) or platform matching (PM). Each site will receive either a bone graft material composed of anorganic bovine bone mineralized (ABBM, Bio-Oss, Geistlich Pharma) or no graft material (collagen membrane used for wound healing (Collatape, Zimmer)). At implant placement surgery and post-surgical follow-ups, the treated site will be examined, clinically measured, and radiographs and photographs will be taken.
The central hypothesis is that the mean crestal bone level for the platform switched (test implants) implants will be superior to the mean crestal bone level for the platform matching (control implants) implants when placed in limited maxillary residual bone in the posterior regions, regardless of the use of bone graft material or collagen membrane.
The central hypothesis is that the mean crestal bone level for the platform switched (test implants) implants will be superior to the mean crestal bone level for the platform matching (control implants) implants when placed in limited maxillary residual bone in the posterior regions, regardless of the use of bone graft material or collagen membrane.
Study Oversight
Has Oversight DMC:
True
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?: