Ti-Mesh Frame Techniques for Dental Bone Grafting

Overseen By Jeremy Kernitsky, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Must not be taking: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate

Disqualifiers: Poor oral hygiene, Chemotherapy, Radiation, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for creating a titanium mesh frame used in dental bone grafting, which prepares for dental implants. One method constructs the frame during surgery, while the other uses a pre-designed frame created with digital technology (CAD-CAM designed and preprinted Ti-Mesh frame). The study aims to determine which method is faster and results in better healing and bone growth. Individuals who have lost some teeth and require moderate bone work for implants might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to advancements in dental technology and improve future treatment options.

Will I have to stop taking my current medications?

If you are currently taking Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements, you will need to stop, as the trial excludes patients on these medications.

What prior data suggests that these Ti-Mesh frame techniques are safe for dental bone grafting?

Research has shown that using titanium mesh for dental bone grafting is generally safe. Studies have found that titanium meshes designed with CAD-CAM technology fit better and may lower surgical risks compared to traditional methods, potentially reducing problems during surgery.

For both CAD-CAM and regular titanium mesh methods, the mesh might become visible through the gums, possibly causing discomfort or infection. However, both types of titanium mesh are considered effective and safe overall, with no major safety differences between them.

In summary, despite some risks like the mesh becoming visible, titanium mesh for bone grafting is considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques for dental bone grafting because they offer innovative ways to approach tooth loss. The CAD-CAM designed and preprinted Ti-Mesh frame is unique as it uses advanced technology to create a precise fit for each patient before surgery, potentially improving outcomes and reducing operating time compared to conventional methods. Meanwhile, the conventional chairside fabrication of the Ti-Mesh frame, while not new, serves as a valuable comparison to measure the effectiveness and efficiency of the CAD-CAM approach. By exploring these techniques, researchers hope to find more efficient, personalized solutions for dental restoration.

What evidence suggests that this trial's techniques could be effective for dental bone grafting?

Research has shown that CAD-CAM designed titanium mesh is effective in dental bone procedures. This mesh fits precisely and may reduce surgical risks. Studies have reported successful bone rebuilding and implant survival with its use. In this trial, participants will be randomized into different treatment arms. One arm will receive the CAD-CAM designed and preprinted Ti-Mesh frame, which could improve results by reducing risks and providing a better fit. Another arm will receive the conventional chairside fabrication of the Ti-Mesh frame, which also works well but might be more likely to become exposed during healing. Both options aim to support bone growth and healing after tooth loss. ^{1 2 4 5 6}

Who Is on the Research Team?

Serge Dibart, DMD

Principal Investigator

BU Goldman School of Dental Medicine, Oral Biology/Periodontics

Albert M Price, DMD

Principal Investigator

BU Goldman School of Dental Medicine, Oral Biology/Periodontics

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo surgery with either CAD-CAM designed and preprinted Ti-MESH or conventional chairside fabricated Ti-MESH

Immediate (surgery duration)

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for wound healing, Ti-MESH exposure rates, and bone production over the study period

1 year

Regular visits at 1, 2, 4, 8, 12, 16, 20, 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months post-op

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12373567/

Comparison between CAD/CAM titanium mesh vs ... Customized titanium mesh (CTM), designed using CAD/CAM or 3D printing, offers a precise fit and may reduce surgical risks. This systematic ...

2. clinicaltrials.gov clinicaltrials.gov/study/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- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0266435624000810

Titanium mesh for guided bone regeneration: a systematic ... The combination of autogenous bone grafts and titanium mesh has achieved good results in bone reconstruction and implant survival. ... (CAD/CAM) customized ...

4. withpower.com withpower.com/trial/phase-tooth-loss-11-2023-a6d7f

Ti-Mesh Frame Techniques for Dental Bone Grafting Research shows that using CAD-CAM designed titanium meshes for bone augmentation in dental procedures is effective, with studies reporting successful bone ...

5. nature.com nature.com/articles/s41368-020-00107-z

Titanium mesh for bone augmentation in oral implantology Titanium mesh has expanded the indications of GBR technology due to its excellent mechanical properties and biocompatibility, so that the GBR ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295274/

Accompanying Titanium Meshes and ... Previous non-randomized studies have reported that GBR-based VRA procedures using CAD/CAM customized titanium meshes with accurate fitting, in ...