Vertical Ridge Augmentation for Vertical Bone Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Steroids, Oral bisphosphonates

Disqualifiers: Infectious disease, Uncontrolled diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

11 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking steroids or have a history of oral bisphosphonate intake for more than 3 years, you may not be eligible to participate.

What data supports the effectiveness of the treatment for vertical ridge augmentation using GBR technique with d-PTFE membrane and Ti-mesh?

Research shows that using titanium-reinforced PTFE membranes for vertical ridge augmentation can be successful, with stable bone levels and good implant function observed over time. Studies indicate that this method can achieve significant vertical bone growth and maintain implant stability, similar to natural bone. ^{1 2 3 4 5}

Is vertical ridge augmentation using PTFE membranes safe for humans?

Vertical ridge augmentation using PTFE membranes has been studied for many years and is generally considered safe, but there can be complications like membrane exposure, which occurs in up to 31% of cases. These exposures can affect healing, but with proper management, satisfactory results can still be achieved. ^{1 2 5 6 7}

How does the treatment for vertical bone loss using GBR with d-PTFE membrane and Ti-mesh differ from other treatments?

This treatment is unique because it uses a titanium-reinforced d-PTFE membrane, which is a non-resorbable material, to support bone growth in areas with significant bone loss. The use of titanium mesh provides additional structural support, making it effective for vertical ridge augmentation, which is challenging with other methods. This approach is particularly beneficial for ensuring long-term stability of dental implants in areas with severe bone resorption. ^{2 3 4 5 8}

What is the purpose of this trial?

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.

Research Team

Yumi Ogata, DMD, DDS, MS

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

This trial is for adults over 18 with missing teeth and specific bone loss in the jaw, who don't smoke. It's not for those allergic to materials used, with infectious diseases like HIV or hepatitis, uncontrolled diabetes (HbA1c >=7), long-term oral bisphosphonate use, steroid medication users, pregnant/lactating women, or those with compromised bone healing.

Inclusion Criteria

I have severe gum ridge deformities on both sides of my mouth.

I am missing two or more teeth in a row.

You do not smoke cigarettes or use any tobacco products.

Exclusion Criteria

I have an infectious disease like HIV, tuberculosis, or hepatitis.

You are allergic to any of the materials used in the study.

I do not have active infections, uncontrolled diabetes, or take bisphosphonates.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Surgery

Participants undergo vertical ridge augmentation using either d-PTFE membrane or Ti-mesh technique

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for post-operative complications and healing progress

6 months

Multiple visits (in-person)

Evaluation

Evaluation of surgical sites and radiographic assessment of bone height

1 day

1 visit (in-person)

Implant Placement

Bone core harvesting and implant placement following standard procedures

1 day

1 visit (in-person)

Treatment Details

Interventions

• GBR technique with d-PTFE membrane
• Ti-mesh technique

Trial Overview The study compares two techniques to rebuild jawbone height: Titanium mesh (Ti-mesh) and a membrane method using d-PTFE. Participants will experience both methods on different sides of their mouth as it's a randomized controlled trial with a split-mouth design.

Participant Groups

Group I: All Study Participants - d-PTFE Experimental Treatment 1 Intervention

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.

Group II: All Study Participants - Ti-mesh Experimental Treatment 1 Intervention

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

References

1. France pubmed.ncbi.nlm.nih.gov

Management of postoperative outcomes of polytetrafluoroethylene membranes in alveolar ridge reconstruction: a systematic review. [2023]

2. Denmark pubmed.ncbi.nlm.nih.gov

Long-term evaluation of osseointegrated implants inserted at the time or after vertical ridge augmentation. A retrospective study on 123 implants with 1-5 year follow-up. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Histological and histomorphometric analysis of bone tissue after guided bone regeneration with non-resorbable membranes vs resorbable membranes and titanium mesh. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical, Radiographic, and Histomorphometric Evaluation of a Vertical Ridge Augmentation Procedure Using a Titanium-Reinforced Microporous Expanded Polytetrafluoroethylene Membrane: A Prospective Case Series with 1-Year Follow-Up. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Vertical Guided Bone Regeneration for a Single Missing Tooth Span with Titanium-Reinforced d-PTFE Membranes: Clinical Considerations and Observations of 10 Consecutive Cases with up to 36 Months Follow-up. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The Screen Technique for Safe Bone Regeneration of Noncontained Defects: A Novel Technique. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Management of the exposure of e-PTFE membranes in guided bone regeneration. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Simultaneous implant placement and vertical ridge augmentation with a titanium-reinforced membrane: a case report. [2016]