Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

Launched by BOSTON UNIVERSITY · Oct 5, 2023

Keywords

ClinConnect Summary

This trial is a randomized study at Boston University comparing two ways to shape a titanium mesh frame used during bone grafts for dental implants after tooth loss. Thirty adults (aged 18–80) who need moderate 3-D bone augmentation and are partially missing teeth will be assigned by chance to either CAD-CAM designed, preprinted Ti-Mesh frames or the conventional chairside-fabricated Ti-Mesh frames. Eligible participants are adults with partial tooth loss and a need for bone augmentation; key exclusions include poor oral hygiene, recent chemotherapy or radiation, certain medications (like bisphosphonates or steroids), smoking more than 10 cigarettes a day, and uncontrolled diabetes or other metabolic disorders.

Participants will undergo surgery with the assigned mesh frame and will be followed for up to a year. The study will measure several things: how accurately the bone contour matches the planned shape at about 5 months after surgery; total and recipient-site surgical times; and post-operative mesh exposure (whether the mesh becomes exposed, its size, and where it occurs) at multiple follow-up points. It will also look at the amount of healthy bone at 6 months and changes in soft tissue thickness using a digital scanner. The trial aims to see if the CAD-CAM preprinted frames save time and improve healing and bone quality compared with the conventional approach. Enrollment is by invitation, the study started in 2024, and completion is estimated for 2026, conducted at BU Goldman School of Dental Medicine.

Gender

ALL

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