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Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Primary Purpose

Tooth Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAD-CAM designed and preprinted Ti-Mesh frame
Conventional chairside fabrication of Ti-Mesh frame
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Conventional Ti-Mesh frame, CAD-CAM printed ti-Mesh frame, Dental implants, 3-D Alveolar Bone Augmentation, Surgery time, Post op mesh exposure, Post op bone added

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • BU Goldman School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAD-CAM Ti-Mesh frame

Conventional Ti-Mesh frame

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Total surgical time
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
Surgical exposure time will be measured for recipient site in minutes

Secondary Outcome Measures

Ti-Mesh exposure incidence
Number of exposures
Ti-Mesh exposure size
Ti-Mesh exposure size will be measured in millimeters
Ti-Mesh exposure location
Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line
Percentage of Vital bone
Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery.

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT06077513
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Conventional Ti-Mesh frame, CAD-CAM printed ti-Mesh frame, Dental implants, 3-D Alveolar Bone Augmentation, Surgery time, Post op mesh exposure, Post op bone added

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD-CAM Ti-Mesh frame
Arm Type
Experimental
Arm Description
Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.
Arm Title
Conventional Ti-Mesh frame
Arm Type
Active Comparator
Arm Description
Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery.
Intervention Type
Procedure
Intervention Name(s)
CAD-CAM designed and preprinted Ti-Mesh frame
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional chairside fabrication of Ti-Mesh frame
Intervention Description
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 Measure Information:
Title
Bone contour accuracy
Description
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.
Time Frame
5 months post op
Title
Total surgical time
Description
Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.
Time Frame
2 hours
Title
Surgical exposure time for recipient site
Description
Surgical exposure time will be measured for recipient site in minutes
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Ti-Mesh exposure incidence
Description
Number of exposures
Time Frame
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Title
Ti-Mesh exposure size
Description
Ti-Mesh exposure size will be measured in millimeters
Time Frame
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Title
Ti-Mesh exposure location
Description
Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line
Time Frame
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Title
Percentage of Vital bone
Description
Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge Dibart, DMD
Phone
(617) 638-4762
Email
sdibart@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Kernitsky, DDS
Phone
(617) 638-4762
Email
jkernits@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Dibart, DMD
Organizational Affiliation
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert M Price, DMD
Organizational Affiliation
BU Goldman School of Dental Medicine, Oral Biology/Periodontics
Official's Role
Study Director
Facility Information:
Facility Name
BU Goldman School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Dibart, DMD
Phone
617-638-4762
Email
sdibart@bu.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Kernitsky, DDS
Phone
(617) 638-4762
Email
jkernits@bu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

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