NCT06077513

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. 1.Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
  2. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

October 5, 2023

Last Update Submit

February 10, 2026

Conditions

Tooth Loss

Keywords

Conventional Ti-Mesh frameCAD-CAM printed ti-Mesh frameDental implants3-D Alveolar Bone AugmentationSurgery timePost op mesh exposurePost op bone added

Outcome Measures

Primary Outcomes (3)

  • 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

  • Total surgical time

    Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.

    2 hours

  • Surgical exposure time for recipient site

    Surgical exposure time will be measured for recipient site in minutes

    5 minutes

Secondary Outcomes (4)

  • Ti-Mesh exposure incidence

    1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

  • Ti-Mesh exposure size

    1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

  • Ti-Mesh exposure location

    1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

  • Percentage of Vital bone

    6 months

Study Arms (2)

CAD-CAM Ti-Mesh frame

EXPERIMENTAL

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

Conventional Ti-Mesh frame

ACTIVE COMPARATOR

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

Interventions

CAD-CAM designed and preprinted Ti-Mesh framePROCEDURE

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.

CAD-CAM Ti-Mesh frame
Conventional chairside fabrication of Ti-Mesh framePROCEDURE

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.

Conventional Ti-Mesh frame

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Partially edentulous
  • Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BU Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Serge Dibart, DMD

    BU Goldman School of Dental Medicine, Oral Biology/Periodontics

    PRINCIPAL INVESTIGATOR

  • Albert M Price, DMD

    BU Goldman School of Dental Medicine, Oral Biology/Periodontics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

January 25, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)