Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

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

Overview

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

• Procedure CAD-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.
• Procedure Conventional 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.

Primary outcome measures

• Bone contour accuracy [Time frame: 5 months post op]
• Total surgical time [Time frame: 2 hours]
• Surgical exposure time for recipient site [Time frame: 5 minutes]

Secondary outcome measures (4)

• Ti-Mesh exposure incidence [Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks]
• Ti-Mesh exposure size [Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks]
• Ti-Mesh exposure location [Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks]
• Percentage of Vital bone [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• BU Goldman School of Dental Medicine — Boston

Identifiers

NCT: NCT06077513 · H-43856 · AP 37

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗