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

42 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Bio-Oss Collagen for tooth loss?

Research shows that Bio-Oss Collagen, used in bone grafting, can help with bone regeneration and improve periodontal (gum) health. Studies have found it effective in reducing probing depth and gaining clinical attachment, which are signs of improved gum and bone health after tooth extraction. ^{1 2 3 4 5}

Is Bio-Oss Collagen Graft safe for humans?

Bio-Oss Collagen has been used in various dental procedures, and studies have not reported significant safety concerns, suggesting it is generally safe for human use. ^{1 2 3 6 7}

How is the Bio-Oss Collagen treatment for tooth loss different from other treatments?

Bio-Oss Collagen is unique because it uses a natural bovine bone mineral that helps in bone conduction, promoting bone growth in areas where teeth have been lost. This treatment is often combined with a collagen membrane to enhance periodontal regeneration, making it different from other treatments that may not use these specific materials or methods. ^{1 2 8 9 10}

What is the purpose of this trial?

The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with Bio-Oss Collagen® at 3, 6 and 9 months following tooth extraction in single-rooted tooth sites. Subjects with single rooted teeth planned for extraction and replacement with endosseous dental implants will be recruited for the study based on the eligibility criteria and will be divided in three groups (Groups 1, 2 and 3).A cone-beam computed tomography (CBCT) scan will be obtained and reviewed to prepare for the surgical approach and evaluate the ridge dimensions, the tooth planned for extraction as well as the adjacent sites. After tooth extraction, the socket will be grafted with Bio-Oss Collagen® and, depending on the morphology of the extraction sockets, a collagen matrix (Mucograft® seal) and/or a restorable collagen membrane (BioGide®)will be placed to cover and stabilize the graft. Patients will return at 2 and 6 weeks post-extraction to evaluate the healing. A second CBCT will be obtained 2 weeks prior to implant placement to evaluate the ridge dimensions and compare them to the baseline data. Implant placement will take place at 12, 24 and 36 after tooth extraction for Groups 1, 2 and 3 respectively. A bone core biopsy will be obtained at the time of implant placement and will be sent for histological analysis. Patients will return for a post-operative visit at two weeks. Clinical indices (probing depth, recession, bleeding upon probing, keratinized mucosa height, plaque and gingival index), patient reported outcomes and marginal bone levels via standardized periapical radiographs will be evaluated and recorded at baseline (no more than 30 days following delivery of final implant restoration) 1, 2 and 3 years post-loading.

Research Team

Carlos Garaicoa Pazmino, DDS

Principal Investigator

University of Iowa

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. China pubmed.ncbi.nlm.nih.gov

[Bio-Oss collagen bone grafting in the treatment of endodontic-periodontic lesion]. [2009]

2. Denmark pubmed.ncbi.nlm.nih.gov

Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Buccal bone plate in immediately placed and restored implant with Bio-Oss(®) collagen graft: a 1-year follow-up study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and histologic evaluation of anorganic bovine bone collagen with or without a collagen barrier. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Bone remodelling marker expression in grafted and ungrafted sheep tooth extraction sockets: A comparative randomised study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Ridge preservation of a novel extraction socket applying Bio-Oss® collagen: An experimental study in dogs. [2022]

7. India pubmed.ncbi.nlm.nih.gov

A comparative evaluation of bovine-derived xenograft (Bio-Oss Collagen) and type I collagen membrane (Bio-Gide) with bovine-derived xenograft (Bio-Oss Collagen) and fibrin fibronectin sealing system (TISSEEL) in the treatment of intrabony defects: A clinico-radiographic study. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

An evaluation of bovine derived xenograft with and without a bioabsorbable collagen membrane in the treatment of mandibular Class II furcation defects. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Two uncommon uses of Bio-Oss for GTR and ridge augmentation following extractions: two case reports. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of periodontal regeneration following grafting intrabony defects with bio-oss collagen: a human histologic report. [2022]