Tooth Loss
Conditions
Keywords
Conventional Ti-Mesh frame, CAD-CAM printed ti-Mesh frame, Dental implants, 3-D Alveolar Bone Augmentation, Surgery time, Post op mesh exposure, Post op bone added
Brief summary
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: 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.
Interventions
PROCEDURECAD-CAM designed and preprinted Ti-Mesh frame
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.
PROCEDUREConventional chairside fabrication of Ti-Mesh frame
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.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Partially edentulous * Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
Exclusion criteria
* Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI) * Patients who have been on Chemotherapy or Radiation therapy within last 5 years. * Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements. * Subjects under the direct supervision of the PI * Smoking more than 10 cigarettes per day * Uncontrolled diabetes or other metabolic disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone contour accuracy | 5 months post op | 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. |
| Total surgical time | 2 hours | Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes. |
| Surgical exposure time for recipient site | 5 minutes | Surgical exposure time will be measured for recipient site in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ti-Mesh exposure incidence | 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks | Number of exposures |
| Ti-Mesh exposure size | 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks | Ti-Mesh exposure size will be measured in millimeters |
| Ti-Mesh exposure location | 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks | Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line |
| Percentage of Vital bone | 6 months | Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSerge Dibart, DMD
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
STUDY_DIRECTORAlbert M Price, DMD
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Outcome results
None listed