OsteoGen for Tooth Extractions

Overseen By Brian Mealey, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Bacitracin, Gentamicin, Polymyxin

Disqualifiers: Pregnancy, Allergies, Mental incompetence, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which material best maintains bone health after tooth extraction. Researchers are comparing two methods: one uses a mix of human donor bone (70% FDBA and 30% DFDBA), and the other uses a synthetic material called OsteoGen, a type of calcium sponge. The goal is to identify which option better promotes new bone growth in the empty tooth space over approximately 16 weeks. Individuals needing a single tooth extraction (not a molar) and planning to receive an implant to fill the gap may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to advance dental health by exploring innovative materials for bone regeneration.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study showed positive results using the OsteoGen Plug for tooth extractions. Patients experienced good bone healing after tooth removal. Research indicates that this material is well-tolerated, with minimal side effects. The OsteoGen Plug consists of a special calcium material combined with a collagen sponge, which stabilizes the area and supports quick healing.

For the other treatment, a mix of two types of bone grafts has been used: freeze-dried bone allograft (FDBA) and demineralized freeze-dried bone allograft (DFDBA). The FDA has approved these materials, confirming their safety for other uses. Patients have generally tolerated these bone grafts well, with few side effects.

Overall, both treatments have proven safe, making them promising options for aiding bone healing after tooth extraction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for tooth extractions because they offer innovative approaches to bone grafting. The OsteoGen Plug is distinct as it combines synthetic calcium apatite with Type 1 bovine collagen, forming a sponge-like structure that may enhance bone regeneration. This is different from traditional methods like freeze-dried bone allografts (FDBA) and demineralized freeze-dried bone allografts (DFDBA), which rely on natural bone materials. The unique combination in OsteoGen aims to provide a more consistent and readily available option for patients, potentially leading to faster healing and better outcomes.

What evidence suggests that this trial's treatments could be effective for ridge preservation after tooth extraction?

Studies have shown that OsteoGen Plugs, one of the treatments tested in this trial, help grow new bone in dental sockets after tooth extractions. This product uses a mix of materials similar to natural bone, effectively preserving the jaw's shape. Research indicates that the OsteoGen Plug absorbs blood and delivers it to the area, crucial for bone growth. It has proven to create strong bone, facilitating the placement of dental implants later. Overall, this treatment has demonstrated good results in preserving bone and supporting healing. Another treatment arm in this trial involves a combination of 70% FDBA and 30% DFDBA, which researchers are comparing to the OsteoGen Plug for effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Brian Mealey, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals who need a tooth extracted and are interested in undergoing ridge preservation to maintain bone volume. Participants should be suitable candidates for dental surgery and willing to follow the study's procedures.

Inclusion Criteria

Site has adequate restorative space for a dental implant-retained restoration

I am between 18 and 89 years old.

I need one tooth pulled out, but it's not a molar.

Exclusion Criteria

Patients who become pregnant during the study will be withdrawn and standard care will be delivered

Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin

Patients who will not cooperate with the follow-up schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Ridge preservation procedure using either calcium apatite/collagen sponge or allograft

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for new bone formation and residual graft material

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination 70% FDBA and 30% DFDBA
• OsteoGen Plug

Trial Overview The study compares two types of materials used in ridge preservation after tooth extraction: OsteoGen Plug (a calcium apatite/collagen sponge) versus a combination of allografts (70% FDBA and 30% DFDBA). The goal is to see which material leads to better new bone formation within about 16 weeks.

How Is the Trial Designed?

Group I: Osteogen Test Group Active Control 1 Intervention

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Group II: FDBA/DFDBA Control Group Active Control 1 Intervention

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/78/NCT05419778/Prot_SAP_000.pdf

Histological evaluation of alveolar ridge preservation using ... The OsteoGen® plug is radiolucent, on the radiograph, when placed in the socket after the extraction and as the crystals are resorbed and replaced by host bone, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34114665/

Comparative in vitro study of commercially available ... This study suggests a product with higher ratio of collagen to mineral component may have the most desirable effects for the use in alveolar ridge preservation.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213398425002921

Evaluation of post dental extraction wound healing and ... The bone loss is indeed substantial during the first three months following extraction and can result in both hard and soft tissue defects ...

4. impladentltd.com impladentltd.com/OsteoGen-Plugs-p/op.htm

OsteoGen Plugs - Bone Graft Solution For Socket ... These dental collagen plugs are clinically proven to grow ideal bone in preparation for dental implants in a controlled and predictable manner. They can be used ...

5. ultradent.com ultradent.com/resources/articles/article?articleTitle=Get%20to%20Know:%20OsteoGen%C2%AE%20Bone%20Graft%20Plugs%20and%20Strips&srsltid=AfmBOoq-wp1yR4_kRQVwn_ep23cLPOGizxpU82Cp9Qxo7cjc8NMuuVKq

Get to Know: OsteoGen® Bone Graft Plugs and Strips The collagen matrix that carries the bone graft efficiently absorbs and delivers blood to the graft during resorption—a crucial factor for the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06447844?term=AREA%5BInterventionSearch%5D(DURAPATITE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=3

OsteoGen Plug vs. Freeze-dried Bone Allograft With ... The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7464229/

Extraction socket preservation using a collagen plug ... A collagen plug is a novel material that has shown promising results in preserving the alveolar bone. PRP has also yielded favorable outcomes in wound healing.

8. impladentltd.com impladentltd.com/Best-Practices-for-Using-OsteoGen-in-Complex-Cases-s/2037.htm

Best Practices for Using OsteoGen® in Complex Cases Its unique composition enhances handling during surgeries while offering excellent stability and reduced healing times. Particularly in complex cases, the use ...