Bone Grafts for Jawbone Preservation

Overseen By Hanae Saito, DDS, MS, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Must not be taking: Systemic corticosteroids

Disqualifiers: Uncontrolled diabetes, Current smoker, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two bone graft materials, Vallomix and Vallos, in maintaining jawbone health after tooth extraction. The goal is to determine if these materials can prevent jawbone shrinkage, facilitating easier placement of dental implants later. Participants will receive one of two bone graft combinations following a tooth extraction and will attend follow-up visits over approximately two years. Individuals needing a back tooth (excluding wisdom teeth) extracted and planning for a dental implant may be suitable candidates. Participation could help preserve jaw structure for future dental work, though it involves regular dental procedures and check-ups. As a Phase 4 trial, this research uses FDA-approved treatments to understand their benefits for more patients, offering a chance to contribute to broader dental health advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or any medication that affects bone healing, you might not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that the bone graft materials being tested, Vallomix and Vallos, are generally well-tolerated by patients. Vallomix consists of a mix of human and animal bone, while Vallos is made solely from human bone. Both materials have been used in other studies to help preserve jawbone after tooth removal.

Previous studies have found that these materials help maintain jawbone health, which is crucial for future dental implants. A healthy jawbone can simplify future dental procedures. Past research has reported no major safety issues with these materials. Most people experience only minor discomfort, the most common issue.

Since this trial is in the later stages (Phase 4), earlier phases have already tested the treatments for safety. This provides more evidence suggesting that these materials are safe for humans. For any concerns, discussing them with a doctor or the study team is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments, Vallomix and Vallos, for jawbone preservation because they offer unique approaches compared to traditional methods like autografts or alloplasts. Vallomix combines demineralized cortical allograft with a xenograft bone substitute, Bio-Oss®, which could enhance bone integration and stability. Vallos uses a mineralized cortico-cancellous bone substitute, potentially offering a more natural bone-like structure for better healing. These innovative materials aim to improve the effectiveness and outcomes of jawbone preservation, sparking interest in their potential benefits over existing options.

What evidence suggests that this trial's treatments could be effective for jawbone preservation?

Research has shown that bone graft materials can help maintain jawbone strength after tooth removal. In this trial, participants will be assigned to one of two groups to test different bone grafting materials. One group will receive a mix of vallos®f (from human bone) and Bio-Oss (from animal bone), which studies have found effective in maintaining bone structure, crucial for future dental implants. The other group will receive vallos®f alone, which also supports bone healing. Combining vallos®f with Bio-Oss might enhance the results. These materials fill the gap left by the removed tooth, reducing bone shrinkage. This method helps ensure sufficient bone for a dental implant later on. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals needing a tooth extraction and planning to get a dental implant. They will be part of a study lasting about 2 years, which includes oral exams, x-rays, surgery, and follow-ups. The goal is to see if grafting materials can preserve jawbone after extraction.

Inclusion Criteria

Provision of informed consent

I have at least one natural tooth next to the area being studied.

I need a back tooth, except for the wisdom tooth, replaced with an implant.

Exclusion Criteria

I do not have any health issues like uncontrolled diabetes that could affect bone healing.

I had a tooth next to the study site removed in the last 6 months.

I currently smoke more than 10 cigarettes a day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo routine tooth extraction, bone graft material placement, and dental implant placement

5 months

Multiple visits for procedures and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up visits after crown placement

1 year

Regular follow-up visits

Long-term follow-up

Participants continue to be monitored for implant success and jawbone preservation

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Vallomix
• Vallos

Trial Overview The study tests two bone graft materials: vallomix® (a mix of xenogeneic/allogeneic bone) and vallos® (allogeneic bone), to see which better preserves the jawbone's integrity for future implants after tooth removal.

How Is the Trial Designed?

Group I: Alveolar ridge preservation with Allograft/Xenograft group Experimental Treatment 1 Intervention

The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with the mixture of demineralized cortical allograft vallos®f and xenograft bone substitute called Bio-Oss®.

Group II: Alveolar ridge preservation with Allograft group Active Control 1 Intervention

The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with mineralized cortico-cancellous bone substitute called vallos®.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06472453

NCT06472453 | Vallomix Socket Preservation Study This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the ...

2. withpower.com withpower.com/trial/phase-alveolar-ridge-augmentations-7-2024-84de3

Bone Grafts for Jawbone Preservation This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction.

3. meddatax.com meddatax.com/clinical-trials/NCT06472453

Vallomix Socket Preservation Study This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction.

4. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/pdf/10.1002/jper.11374

Healing following ridge preservation using demineralized ... Placing a bone graft in the socket after tooth extraction can decrease bone loss during healing in preparation for a dental implant. This study ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40702945/

Healing following ridge preservation using demineralized ... This study evaluated histologic wound healing when using demineralized freeze-dried bone allograft (DFDBA) alone, in fiber or particulate form, ...

6. geistlich.us geistlich.us/vallomix/

Geistlich vallomix vallos® is an allogeneic bone in the form of granules, whereas vallos®f is an allogeneic bone in the form of fibers (shavings from cortical bone). vallos®f ...