Ti-Mesh Frame Techniques for Dental Bone Grafting

Overseen by Serge Dibart, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Albert M Price, DMD

Principal Investigator

BU Goldman School of Dental Medicine, Oral Biology/Periodontics

Serge Dibart, DMD

Principal Investigator

BU Goldman School of Dental Medicine, Oral Biology/Periodontics

Eligibility Criteria

This trial is for adults with some missing teeth who need bone growth in the jaw to prepare for dental implants. They must have good oral hygiene and not be heavy smokers or on certain medications like bisphosphonates or glucocorticoids, nor should they have had chemotherapy or radiation therapy within the last five years.

Inclusion Criteria

I am missing some of my teeth.

I need a dental procedure to prepare for an implant due to bone loss.

Exclusion Criteria

I am currently taking medications like Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.

Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)

I have undergone chemotherapy or radiation therapy in the past 5 years.

Treatment Details

Interventions

• CAD-CAM designed and preprinted Ti-Mesh frame (Procedure)
• Conventional chairside fabrication of Ti-Mesh frame (Procedure)

Trial Overview The study compares two methods of creating Titanium Mesh frames used in bone grafting: one made by hand during surgery (conventional) and another designed beforehand using CAD-CAM technology. It will assess which method is quicker and how well each heals over a year.

Participant Groups

Group I: CAD-CAM Ti-Mesh frame Experimental Treatment 1 Intervention

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

Group II: Conventional Ti-Mesh frame Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+