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

Trial Summary

What is the purpose of this trial?

This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the jawbone surrounding the removed tooth can shrink, affecting future implant placement. By placing a bone graft material in the extraction socket, we aim to maintain adequate jawbone space for future implants. This study compares how well the mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) \[test\], and vallos® only \[control\] grafting materials work. Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study. Participants will be randomly assigned to either the mixture of vallos®f and Bio-Oss (test) group or the vallos® only (control) group. Throughout the approximately 2-year study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material placement, and dental implant placement. After the crown is placed on the implant, participants will attend follow-up visits. Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.

Eligibility Criteria

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

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

Provision of informed consent

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

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

Treatment Details

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.

Participant Groups

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+