Bio-Oss Collagen Graft for Tooth Loss

Overseen By Gustavo Avila-Ortiz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gustavo Avila-Ortiz DDS, MS, PhD

Must not be taking: IV bisphosphonates, Oral bisphosphonates, Glucocorticoids

Disqualifiers: Acute infection, Heart disease, Diabetes, Osteoporosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well Bio-Oss Collagen, a bone graft material, aids healing after the removal of a single-rooted tooth. The research aims to assess the graft's impact on recovery at 3, 6, and 9 months post-extraction, before placing a dental implant. Participants will be divided into three groups based on when they receive their implant, helping researchers determine the best timing for implant placement. The trial seeks individuals who need a single-rooted tooth removed, plan to replace it with an implant, and have no major health issues affecting healing. As an unphased trial, it offers participants the chance to contribute to understanding optimal recovery and implant timing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect bone metabolism, like certain bisphosphonates or glucocorticoids.

What prior data suggests that Bio-Oss Collagen is safe for use in dental procedures?

Research has shown that Bio-Oss Collagen® is generally safe and well-tolerated for dental procedures. Made from cow bone, it undergoes careful cleaning to ensure safety. Studies have found it to be biocompatible, meaning it integrates well with the body without causing harm.

When used to preserve bone after tooth removal, Bio-Oss Collagen® has proven effective. In over 90% of cases, it maintains good bone structure without requiring additional bone grafts. Although specific side effects are not detailed, its approval for dental use by health authorities indicates its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional bone grafts that often rely on autografts or allografts, Bio-Oss Collagen is a xenograft, meaning it's derived from animal sources. This makes it unique because it can potentially reduce the need for a second surgical site, which is typically required to harvest bone for autografts. Researchers are excited about Bio-Oss Collagen because it combines bovine-derived bone mineral with collagen, which may enhance bone regeneration and support better implant stability. Additionally, this treatment offers flexibility in timing for implant placement, allowing for personalized treatment plans based on patient needs.

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

Studies have shown that Bio-Oss Collagen effectively preserves bone around teeth after extraction. Research indicates it significantly reduces bone loss, stabilizing the area for future dental implants. One study found that Bio-Oss Collagen reduced bone loss by about 2.37 mm, keeping the bone healthier and more intact compared to not using the graft. Overall, Bio-Oss Collagen has proven to be a reliable option for maintaining bone structure post-extraction. Participants in this trial will receive Bio-Oss Collagen with implant placement at different intervals after tooth extraction to assess its effectiveness over time. ^{4 6 7 8 9}

Who Is on the Research Team?

Carlos Garaicoa Pazmino, DDS

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults needing a single-rooted tooth (not mandibular incisors) extracted and replaced with an implant. Candidates should be in good health, able to undergo dental procedures, and willing to sign consent. Exclusions include severe bone diseases, significant organ impairments, heavy smokers, pregnant or nursing women, those on certain medications affecting bone metabolism.

Inclusion Criteria

Subjects must have read, understood and signed an informed consent form

My tooth extraction site has intact walls or only one side is partially missing.

I am healthy enough for dental surgery, including tooth removal and implants.

Exclusion Criteria

I am willing to attend all required visits.

I do not have major health issues that could affect treatment or healing.

I am not on long-term medications that affect bone health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Tooth Extraction and Ridge Preservation

Tooth extraction and socket grafting with Bio-Oss Collagen®

1 day

1 visit (in-person)

Post-operative Monitoring

Post-operative visits to assess healing and remove sutures

6 weeks

3 visits (in-person)

Implant Placement

Placement of dental implants and bone core biopsy

12-36 weeks post-extraction depending on group

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implant placement

3 years

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bio-Oss Collagen

Trial Overview The study tests how well the Bio-Oss Collagen® graft aids healing after tooth extraction at different intervals: 3, 6, and 9 months. Participants are divided into three groups; each group receives implants at different times post-extraction (12, 24 or 36 weeks), followed by evaluations including CBCT scans and biopsies.

How Is the Trial Designed?

Group I: Implant placement 3 mo. after tooth ext. Experimental Treatment 1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 3 mo. after tooth ext.

Group II: Implant placement 9 mo. after tooth ext. Active Control 1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 9 mo. after tooth ext.

Group III: Implant placement 6 mo. after tooth ext. Active Control 1 Intervention

Alveolar ridge preservation using xenograft (BioOss Collagen) and Implant placement 6 mo. after tooth ext.

Who Is Running the Clinical Trial?

Gustavo Avila-Ortiz DDS, MS, PhD

Lead Sponsor

Trials

4

Recruited

100+

Theodoros Katsaros, DDS, MSD

Lead Sponsor

Trials

1

Recruited

40+

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Geistlich Pharma AG

Industry Sponsor

Trials

45

Recruited

2,300+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2590093525000281

Micro-CT and histological evaluation of alveolar ridge ... Ridge preservation of extraction sockets with chronic pathology using Bio-Oss (®) Collagen with or without collagen membrane: an experimental study in dogs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046471/

Clinical and Histologic Outcomes of Biologically Oriented ... This study aimed to evaluate the efficacy of Biologically oriented Alveolar Ridge Preservation (BARP) in minimizing post‐extraction ridge ...

3. geistlich.com geistlich.com/fileadmin/content/International_Pharma/PDF/Dental_EN/Others/Geistlich_News_Ridge_Preservation_EN.pdf

RIDGE PRESERVATION. Studies over the past few years have clearly shown that Ridge Preservation significantly reduces ridge volume loss after tooth extraction. Animal and clinical ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04338516

Ridge Preservation Using a Ossix™ Bone vs Bio-Oss ... The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio- ...

5. nature.com nature.com/articles/s41598-023-50370-3

Effectiveness of a collagen matrix seal and xenograft in ... A recent systematic review found that alveolar ridge preservation (ARP) with a compromised buccal wall reduced horizontal bone loss by 2.37 mm ...

6. accessdata.fda.gov accessdata.fda.gov/CDRH510K/K122894.pdf

K122894 - accessdata.fda.gov ... Oss® and Geistlich Bio-Oss Collagen® is as safe as sourcing bovine bone from that is currently used for the manufacture of Geistlich. Bio-Oss ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/k122894.pdf

Geistlich Bio-Oss - accessdata.fda.gov Geistlich Bio-Oss® is a biocompatible bone mineral matrix and is manufactured from bovine bone in a validated multistage purification process to ...

8. geistlich-na.com geistlich-na.com/dental-professionals/bone-substitutes/bio-oss-collagen

Geistlich Bio-Oss Collagen - Bone Substitutes / Geistlich Bio-Oss Collagen® is ideal for Guided Bone Regeneration, particularly for Ridge Preservation after tooth extraction and bone regeneration around ...

9. geistlich.com geistlich.com/fileadmin/content/International_Pharma/PDF/Dental_EN/TAs/601261_BRO_Solution_after_tooth_EN_2006.pdf

Solutions after tooth extraction If Ridge Preservation (e.g. with. Geistlich Bio-Oss® and Geistlich. Bio-Gide®) is performed after tooth extraction, in more than. 90% of cases no further bone.