Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077513
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-28
First Post:
2023-10-05
Brief Title:
Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Human Alveolar Bone Augmentation Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided designcomputer-assisted manufacture CAD-CAM Titanium Mesh frame In addition a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries
The device used for shaping is a very thin perforated titanium metal sheet with numerous small perforations referred to as Micromesh The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface A digitally designed frame can then be printed using CAD-CAM software prior to surgery This should reduce surgical time
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives
1 Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
2 Compare post-op wound healing -Ti MESH exposure rates bone production volume contour and quality and soft tissue thickness changes during the 1-year study period
The device used for shaping is a very thin perforated titanium metal sheet with numerous small perforations referred to as Micromesh The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface A digitally designed frame can then be printed using CAD-CAM software prior to surgery This should reduce surgical time
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives
1 Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
2 Compare post-op wound healing -Ti MESH exposure rates bone production volume contour and quality and soft tissue thickness changes during the 1-year study period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AP 37 | OTHER | Geistlich Pharma North America Inc | None |