Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AP 37 | Other Identifier | Geistlich Pharma North America Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD-CAM Ti-Mesh frame | Experimental | Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery. |
|
| Conventional Ti-Mesh frame | Active Comparator | Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD-CAM designed and preprinted Ti-Mesh frame | Procedure | CAD-CAM technology which is the process of designing and manufacturing a custom-made dental device, or a patient-specific dental device from an industrialized product, with the aid of a computer.will be used to plan and preprint a 3-D Ti-Mesh frame prior to the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone contour accuracy | Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform. | 5 months post op |
| Total surgical time | Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes. | 2 hours |
| Surgical exposure time for recipient site | Surgical exposure time will be measured for recipient site in minutes | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ti-Mesh exposure incidence | Number of exposures | 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
| Ti-Mesh exposure size | Ti-Mesh exposure size will be measured in millimeters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Serge Dibart, DMD | BU Goldman School of Dental Medicine, Oral Biology/Periodontics | Principal Investigator |
| Albert M Price, DMD | BU Goldman School of Dental Medicine, Oral Biology/Periodontics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BU Goldman School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional chairside fabrication of Ti-Mesh frame | Procedure | A three-dimensional frame or cage of Ti-Mesh or Ti-reinforced d-polytetrafluoroethylene (PTFE) will be fashioned during the surgery to contain, shape and stabilize the bone graft materials (the internal scaffold). This 3-D frame will be custom fabricated from a perforated Ti Mesh sheet material at the time of surgery which takes considerable time and skill. |
|
| 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
| Ti-Mesh exposure location | Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line | 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks |
| Percentage of Vital bone | Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery. | 6 months |