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Enrolling by Invitation

NCT Number: NCT06077513

Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BU Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAD-CAM designed and preprinted Ti-Mesh frame

Procedure

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

Procedure

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 outcomes

  1. Bone contour accuracy

    Time frame: 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.

  2. Total surgical time

    Time frame: 2 hours

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

  3. Surgical exposure time for recipient site

    Time frame: 5 minutes

    Surgical exposure time will be measured for recipient site in minutes

Secondary outcomes

  1. Ti-Mesh exposure incidence

    Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

    Number of exposures

  2. Ti-Mesh exposure size

    Time frame: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks

    Ti-Mesh exposure size will be measured in millimeters

  3. Ti-Mesh exposure location

    Time frame: 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

  4. Percentage of Vital bone

    Time frame: 6 months

    Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Human Alveolar Bone Augmentation: Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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