Guided Bone Regeneration for Horizontal Ridge Deficiency

Overseen By Alice Ou, RDH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Immunosuppressants

Disqualifiers: Smoking, Alcohol abuse, Pregnancy, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different materials to aid in regrowing bone in the jaw, beneficial for individuals with gaps from missing teeth. Researchers aim to determine whether a custom-made titanium mesh or a type of plastic mesh better supports new bone growth. This process is known as Guided Bone Regeneration (GBR). The trial seeks participants with moderate jawbone loss in the back of the mouth, who are otherwise healthy or have mild, well-controlled health conditions. As an unphased trial, this study allows participants to contribute to innovative research that may enhance future dental treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have uncontrolled diabetes, you may not be eligible to participate.

What prior data suggests that these membranes are safe for guided bone regeneration?

Previous studies have shown that specially designed titanium meshes effectively aid bone regrowth in areas with severe bone loss. These meshes simplify surgery and reliably support bone growth.

Reinforced PTFE mesh membranes also cover bone grafts. Although specific safety data on these PTFE membranes is limited, their testing in trials suggests they are reasonably safe for similar treatments.

Both mesh types aim to promote new bone growth without causing significant harm. However, as with any medical treatment, risks or side effects may occur, and individual experiences can vary. Prospective participants should consult a healthcare provider about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new method for treating horizontal ridge deficiency because it uses innovative materials to cover bone grafts. The customized CAD/CAM Titanium Mesh is unique due to its tailored fit, which can enhance stability and integration with the bone. Meanwhile, the Reinforced Perforated PTFE Mesh (RPM) offers a strong yet flexible barrier, allowing for optimal bone growth while protecting against soft tissue intrusion. These materials aim to improve the effectiveness and predictability of guided bone regeneration compared to traditional membranes.

What evidence suggests that this trial's treatments could be effective for horizontal ridge deficiency?

This trial will compare two methods for guided bone regeneration in horizontal ridge deficiency. One arm will use a customized CAD/CAM Titanium Mesh, which research has shown to be very effective for bone growth. In past studies, these titanium meshes helped implants succeed 100% of the time, making them a reliable choice for complex bone rebuilding. They consistently support bone growth in both height and width. The other arm will use a Reinforced Perforated PTFE Mesh (RPM), which also provides strong support for bone grafts. While both materials promote bone growth, titanium meshes have demonstrated particularly good results in successful bone growth and implant stability. ^{1 2 3 6 7}

Who Is on the Research Team?

Hom-Lay Wang, DDS MSD PhD

Principal Investigator

Department of Periodontics and Oral Medicine, University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are healthy or have mild to moderate controlled diseases. They should have missing teeth in the back of their lower jaw with bone defects and be able to understand the study's terms. Smokers, pregnant individuals, those with autoimmune disorders, recent radiotherapy patients, substance abusers, or people with severe organ dysfunction cannot participate.

Inclusion Criteria

I am generally healthy or have a mild to moderate condition that is under control.

I have missing teeth in the back of my lower jaw with bone loss of at least 3mm.

I understand and agree to the study's conditions.

Exclusion Criteria

Autoimmune disorders

Smoking habit of >10 cigarettes/day (self-reported)

I have undergone radiotherapy within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mandibular ridge augmentation using either Customized CAD/CAM Titanium Mesh or Reinforced Perforated PTFE Mesh

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic and histological assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Guided Bone Regeneration (GBR)

Trial Overview The study aims to compare two techniques for increasing bone density in the jaw where teeth are missing: using a custom-made titanium mesh versus a reinforced PTFE mesh. The goal is to see which method is better for both vertical and horizontal growth of the jawbone.

How Is the Trial Designed?

Group I: Customized CAD/CAM Titanium Mesh Experimental Treatment 1 Intervention

A customized CAD/CAM Titanium Mesh will be used to cover the bone graft

Group II: Reinforced Perforated PTFE Mesh (RPM) Active Control 1 Intervention

A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33548069/

Customized CAD/CAM titanium meshes for the guided ... The study used customized titanium meshes for guided bone regeneration, achieving a 100% implant survival rate, and concluded that the meshes are a reliable ...

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

Titanium mesh for guided bone regeneration The review shows that the use of titanium mesh is a predictable method for the rehabilitation of complex atrophic sites.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/clr.13720

Customized CAD/CAM titanium meshes for the guided ... The outcomes were vertical and horizontal bone augmentation changes, biological complications and implant survival. Results. Out of 53 sites, 11 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293224/

Vertical and horizontal ridge augmentation using ... The aim was to evaluate the role of resorbable membranes applied over customized titanium meshes related to soft tissue healing and bone regeneration.

5. foliamedica.bg foliamedica.bg/article/123766/

Linear bone gain and healing complication rate ... The use of a custom-made 3D printed titanium mesh for vertical guided bone regeneration showed results comparable to those of the gold standard – Ti d- PTFE .

6. mdpi.com mdpi.com/2673-1592/5/2/33

Full-Digital Customized Meshes in Guided Bone ... In complex bone defects, patient-specific Ti-mesh has been demonstrated to potentially concur to significant bone augmentation up to 11.48 mm in ...

7. geistlich.us geistlich.us/yxoss-cbr/

Yxoss CBR®- Customized Bone Regeneration | Titanium Mesh Custom-made titanium scaffold with precision fit · Accurately reflects specific patient data · 3D digital planning and design · Provides a solution for vertical ...