Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Not Applicable

• Conditions: Tooth Loss
• Interventions: Procedure: Conventional chairside fabrication of Ti-Mesh frame; Procedure: CAD-CAM designed and preprinted Ti-Mesh frame

• Registration Number: NCT06077513
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Study Start: 2024-01-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Ti-Mesh frame	Conventional chairside fabrication of Ti-Mesh frame	Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery.
CAD-CAM Ti-Mesh frame	CAD-CAM designed and preprinted Ti-Mesh frame	Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.

Primary Outcome Measures

Name	Time	Method
Surgical exposure time for recipient site	5 minutes	Surgical exposure time will be measured for recipient site in minutes
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.

Secondary Outcome Measures

Name	Time	Method
Ti-Mesh exposure incidence	1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks	Number of exposures
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.
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

Trial Locations

Locations (1)

BU Goldman School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States