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Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

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  1. Notable Primary completion pushed from Sep 2026 to Sep 2027
    • Study completion pushed from Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 8 words
  2. Minor Study completion date: Sep 2026 to Dec 2026v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Minor Start date changed from estimate of Feb 2024 to Jan 25, 2024v4
  5. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Jan 2024 to Feb 2024
    • Site contact updated
    v3
  6. Minor Start date: Dec 2023 to Jan 2024v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06077513
Lead Sponsor Boston University
Conditions
(from sponsor)
Tooth Loss
Related terms Tooth Loss
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov