Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Sponsor

Boston University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06077513

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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:

Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Loss	Procedure: CAD-CAM designed and preprinted Ti-Mesh frame Procedure: Conventional chairside fabrication of Ti-Mesh frame	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAD-CAM Ti-Mesh frame Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.	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.
Active Comparator: Conventional Ti-Mesh frame Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during 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.

Arm

Intervention/Treatment

Experimental: CAD-CAM Ti-Mesh frame

Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.

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.

Active Comparator: Conventional Ti-Mesh frame

Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BU Goldman School of Dental Medicine	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

Boston University

Investigators

Principal Investigator: Serge Dibart, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Study Director: Albert M Price, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics