Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Tooth Loss Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06077513
• Other study ID #: H-43856
• Secondary ID: AP 37
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	BU Goldman School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total surgical time	Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.	2 hours
Primary	Surgical exposure time for recipient site	Surgical exposure time will be measured for recipient site in minutes	5 minutes
Secondary	Ti-Mesh exposure incidence	Number of exposures	1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Secondary	Ti-Mesh exposure size	Ti-Mesh exposure size will be measured in millimeters	1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Secondary	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
Secondary	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