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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for regrowing bone in the jaw: the Titanium mesh (Ti-mesh) technique and the Guided Bone Regeneration (GBR) technique using a special d-PTFE membrane. It targets individuals who have lost bone in their jaws due to gaps from missing two or more teeth. Non-smokers with specific jawbone issues may qualify. The goal is to determine which method more effectively promotes new bone growth in these areas. As an unphased study, this trial provides an opportunity to contribute to innovative dental research and potentially benefit from advanced bone regeneration techniques.

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 prior data suggests that these vertical augmentation techniques are safe?

Research has shown that both the GBR technique with a d-PTFE membrane and the Ti-mesh technique are generally safe for increasing bone height. However, some important considerations exist.

For the GBR technique using the d-PTFE membrane, studies have found potential issues during the procedure, such as membrane exposure. These issues are not uncommon, so awareness is crucial.

The Ti-mesh technique also yields positive results in bone growth, with some studies showing an average increase of about 4.8 mm. This method is generally considered reliable and effective. However, like the GBR technique, it may involve surgical issues.

Both techniques carry the possibility of complications, necessitating careful consideration and monitoring. Prospective trial participants should keep these safety aspects in mind. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for vertical ridge augmentation because it explores two promising techniques—GBR with a d-PTFE membrane and the Ti-mesh technique—both aiming to tackle vertical bone loss in innovative ways. Unlike traditional methods that might struggle with structural stability, the Ti-mesh technique provides a sturdy framework for bone growth, potentially enhancing the results. Meanwhile, the GBR technique with a d-PTFE membrane offers a different approach by using a high-density material to aid in bone regeneration while keeping out unwanted tissue. This trial could reveal which technique offers better outcomes, paving the way for improved treatments for patients with bone loss.

What evidence suggests that this trial's treatments could be effective for vertical bone loss?

This trial will compare two vertical augmentation procedures: the GBR method with a special d-PTFE membrane and the Ti-mesh method. Research has shown that both methods effectively promote vertical bone growth. Participants may receive the Ti-mesh method, which studies found can result in an average bone growth of about 4.8 mm. Alternatively, participants may receive the GBR method, proven to regrow bone with results similar to the titanium mesh. Both treatments have demonstrated promising results in increasing bone levels, making them viable options for those considering vertical ridge augmentation. ^{5 6 7 8 9}

Who Is on the Research Team?

Yumi Ogata, DMD, DDS, MS

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9303140/

Effect of Different Membranes on Vertical Bone Regeneration This study is aimed at performing a systematic review and a network meta-analysis of the effects of several membranes on vertical bone ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06242782

NCT06242782 | Vertical Ridge Augmentation Strategies However, when horizontal augmentation procedures were reviewed, a higher rate (21%) of complications was reported within the first 18 months of a GBR procedure.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cid.13173

Vertical ridge augmentation with Ti‐reinforced dense ... The medium-term results of this RCT showed the stability of PBLs and interproximal bone levels up to 3 years after VRA in the posterior mandible ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023006953

Evaluation of efficacy of non-resorbable membranes ... Vertical and horizontal ridge augmentation procedures overcome this hurdle. Guided bone regeneration (GBR) is a regenerative technique for ridge augmentation.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949596/

Impact of Collagen Membrane in Vertical Ridge ... This non‐inferiority randomised clinical trial aimed to compare vertical bone gain (VBG), volumetric bone changes and incidence of complications after vertical ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468785523001957

Complications associated with vertical bone augmentation ... Vertical bone augmentation procedures prior to implant placement are associated with frequent surgical complications and should be approached with caution.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02703480

Comparing the Efficacy and Morbidity of Two Vertical ... Bone harvesting using bone scrapers will be performed during GBR procedures with both techniques (d-PTFE and Ti-mesh). Bone harvesting using bone scrapers is ...

9. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-022-02513-7

Reconstruction of vertical alveolar ridge deficiencies utilizing a ... The aim of this study was to evaluate the effects of membrane exposure during vertical ridge augmentation (VRA) utilizing guided bone regeneration.