Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
Enrolling by invitation · Not applicable
Conditions studied: Tooth Loss
In brief
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.
Key facts
- Study ID
- NCT06077513
- Run by
- Boston University
- People needed
- 30
- Starts
- 2024-01-25
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Partially edentulous
- Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
You may not qualify if…
- 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
Where it is running
- BU Goldman School of Dental Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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