Bone Graft for Wound Healing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Bisphosphonates, Anti-inflammatories

Disqualifiers: Diabetes, Cancer, Osteoporosis, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-extraction

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores various materials for bone grafts to determine which best promotes new bone growth after tooth extraction. Researchers compare a synthetic bone graft made from carbonate apatite to two other types: one from human donors and another from cows. Suitable participants need a tooth removed, have no infection in the area, and are considering a future dental implant. As an unphased trial, this study offers a unique opportunity to advance dental treatments and potentially benefit from innovative bone graft materials.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect bone healing, like bisphosphonates or long-term anti-inflammatory drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that carbonate apatite bone grafts, such as those in Cytrans Granules, imitate the natural minerals in bones. Studies indicate that this material supports stable and positive bone growth, suggesting its safety and effectiveness.

For the xenograft option, research highlights that bovine-derived xenografts, like Bio-Oss, adhere to strict quality and safety standards. However, concerns exist about the long-term risk of disease and their inability to break down naturally in the body.

In trials like the one for the carbonate apatite bone graft, safety remains a primary focus. If the treatment reaches a later phase, earlier studies usually provide some evidence of safety. Carbonate apatite has been well-tolerated in similar situations. Meanwhile, xenografts, despite some concerns, have been widely used as reliable alternatives to other bone grafts. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer fresh approaches to bone grafting, which is crucial for wound healing. Traditional bone grafts often use autografts or allografts, which can be limited by donor availability and risk of rejection. The synthetic carbonate apatite in Cytrans Granules is designed to mimic natural bone, potentially improving integration and healing. Meanwhile, the xenogeneic plug in BioOss uses material derived from other species, which might offer a unique scaffold for bone regeneration. These innovative materials could expand options for patients needing bone grafts, providing new pathways for quicker and more effective healing.

What evidence suggests that this trial's treatments could be effective for wound healing?

Research has shown that carbonate apatite bone grafts, one of the treatments in this trial, effectively promote new bone growth. These grafts perform as well as using a patient's own bone, which remains the best option available. The carbonate apatite material can be easily shaped to fit bone gaps and stays in place, aiding the healing process.

Another treatment option in this trial is xenografts, derived from animals. Xenografts also support bone growth effectively and consistently perform well in bone repair. They have been successfully used in various dental procedures. Both treatments show promising results in aiding bone healing, making them strong options for wound healing. ^{3 5 6 7 8}

Who Is on the Research Team?

Hom-Lay Wang, DDS,MSD,PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals needing alveolar ridge preservation, typically after tooth extraction. Specific eligibility criteria are not provided, but generally participants would need to be in good health with no contraindications for dental surgery.

Inclusion Criteria

I am considering getting a dental implant after tooth removal.

I am between 20 and 80 years old.

I need a tooth removed due to decay, gum disease, breakage, or it can't be fixed.

Exclusion Criteria

Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)

I have a blood disorder.

I do not have any active infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bone grafting with either allograft, xenograft, or synthetic bone graft material after tooth extraction

Immediate post-extraction

Follow-up

Participants are monitored for bone formation and alveolar ridge changes

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Carbonate Apatite Bone Graft

Trial Overview The study is testing the effectiveness of a synthetic bone graft material called carbonate apatite compared to human and bovine-derived materials in promoting bone growth for dental patients.

How Is the Trial Designed?

Group I: Xenograft Experimental Treatment 1 Intervention

Bone graft with xenogeneic plug (BioOss)

Group II: Synthetic bone Experimental Treatment 1 Intervention

Bone graft with carbonate apatite (Cytrans Granules)

Group III: Allograft Active Control 1 Intervention

Bone graft with allograft (Puros)

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/38787711/

Novel Synthetic Carbonate Apatite as a Bone Substitute in ... The aim of this report is to evaluate the efficacy of CO3Ap granules in implant treatments when used alone or in combination with autogenous ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07020650

The Effectiveness of Carbonate Apatite Bone Graft for ... This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and ...

3. frontiersin.org frontiersin.org/journals/dental-medicine/articles/10.3389/fdmed.2024.1418039/full

A systematic review of a novel alloplast carbonate apatite ... Replacement of CO3Ap-granules with new bone formation has been shown to be comparable to autogenous bone grafting with one study showing ...

4. mdpi.com mdpi.com/2304-6767/13/2/85

Guided Bone Regeneration Using Carbonated Apatite ... This case series details the clinical, radiographic, and histological results of ridge augmentation using bone graft comprising a P(LA/LC) membrane and ...

5. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/10.1002/adhm.202303245

Transformable Carbonate Apatite Chains as a Novel Type ... Carbonate apatite chains can be easily filled in the bone defect without migration. The chain's transformability improves the conformity to ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192597.pdf

GC America, Inc. H. Jenkins Official Correspondent Wood ... The material of Cytrans Granules has been formulated in terms of carbonate apatite content to be similar to the mineral content of natural bone.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10969457/

Ridge Preservation and Augmentation Using a Carbonated ... Ultimately, the use of carbonated apatite alone as a bone graft material in implant therapy resulted in stable and favorable bone regeneration.

8. gc.dental gc.dental/gc-biomaterials/cytrans-granules

Cytrans® Granules | GC Biomaterials Resorbable Bone Graft Material. Cytrans® Granules are composed of carbonate apatite with excellent osteoconductivity, leading to early bone formation.