Biotivity A-C Membrane for Alveolar Ridge 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: Corticosteroids, others

Disqualifiers: Uncontrolled diabetes, Smoker, Alcohol abuse, 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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of membranes to preserve the jawbone after removing a back tooth. It compares a new amnion chorion membrane (Biotivity A/C Plus Membrane, derived from the placenta) to a regular collagen membrane, focusing on their effectiveness in supporting healing and maintaining jaw size before a dental implant. Individuals needing a back tooth removed and planning for a dental implant might be suitable candidates. Participants will undergo routine tooth extraction and receive one of the two membranes during the procedure. The main benefit is maintaining the jaw's condition, which facilitates easier placement of future dental implants. As a Phase 4 trial, this research highlights that the treatment is already FDA-approved and effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on systemic corticosteroids or any medication that affects bone healing, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that the Biotivity A/C Plus Membrane is generally safe for dental procedures, such as preserving the jawbone after tooth extraction. Derived from human placenta, this membrane has been used in similar procedures without major safety issues. Patients have reported good results in healing and bone preservation, indicating its safety.

Additionally, this membrane is already used in various dental surgeries, such as building up the jawbone and preparing for dental implants. Its widespread use supports its safety. As a Phase 4 study, this trial follows earlier safety tests and now tests the treatment on a larger group to confirm its safety and effectiveness.

While participating in the trial may involve some typical discomfort from dental procedures, the Biotivity membrane itself is not known to cause major side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Biotivity A-C Plus Membrane because it offers a novel approach to alveolar ridge preservation by using an amnion chorion membrane. Unlike traditional collagen membranes, which are commonly used in dental procedures, the amnion chorion membrane is derived from human placental tissue, providing a natural source of growth factors that may enhance healing and bone regeneration. This innovative membrane could potentially improve outcomes by promoting more efficient tissue integration and reducing inflammation. By exploring this unique mechanism, the hope is to offer patients a more effective option for maintaining bone structure after tooth extraction.

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

This trial will compare the Biotivity A-C Plus Membrane with a collagen membrane for alveolar ridge preservation. Research has shown that the Biotivity A-C Plus Membrane helps preserve the jawbone after tooth extractions. This special membrane supports gum healing and maintains bone structure, which is important for dental implants. Studies comparing it to regular collagen membranes suggest it may better preserve the bone needed for implants. The membrane aids in healing and bone preservation, crucial for successful dental implant placement. These findings suggest it could improve outcomes for those needing tooth replacements. ^{1 2 3 6 7}

Who Is on the Research Team?

Hanae Saito, DDS MS CCRC

Principal Investigator

University of Maryland School of Dentistry

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a posterior tooth (excluding wisdom teeth) extracted and replaced with an implant. They must have at least one natural tooth next to the site, provide consent, and have a specific type of extraction socket identified by CT scan.

Inclusion Criteria

My dental scan shows I have a Type I or II tooth socket.

I have given my consent to participate.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Alveolar Ridge Preservation Surgery

Participants undergo atraumatic tooth extraction and alveolar ridge preservation with either amnion chorion membrane or collagen membrane

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for soft tissue wound healing and hard/soft tissue dimensional changes

5 months

Multiple visits (in-person)

Dental Implant Placement

Participants receive dental implants after 5 months of healing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for implant integration and final restoration delivery

1 month

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biotivity A/C Plus Membrane
• Collagen membrane

Trial Overview The study compares two methods of preserving the jawbone after tooth extraction: using a human placental-derived membrane versus a conventional collagen membrane. It aims to see which is better for healing and maintaining jaw dimensions before implant placement.

How Is the Trial Designed?

Group I: Alveolar ridge preservation with amnion chorion membrane Experimental Treatment 1 Intervention

The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called Biotivity™ A-C Plus.

Group II: Alveolar ridge preservation with collagen membrane Active Control 1 Intervention

The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called CopiOs.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07091448

Biotivity A-C Membrane Socket Preservation Study This study aims to determine whether the amnion chorion membrane provides superior soft tissue healing and volumetric bone preservation compared to conventional ...

2. withpower.com withpower.com/trial/phase-4-alveolar-ridge-preservation-10-2025-293cb

Biotivity A-C Membrane for Alveolar Ridge Preservation The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29140383/

A Randomized Split-Mouth Clinical Trial on Effectiveness ... The aim of this study was to compare the effectiveness of these membranes in ridge preservation, particularly when they are intentionally left exposed.

4. zimvie.com zimvie.com/en/dental/biomaterial-solutions/membranes/biotivity-a-c-plus-membrane.html

Biotivity A/C Plus Membrane | ZimVie Americas It is used in GTR and GBR procedures, socket and ridge preservation, ridge augmentation, Schneiderian membrane perforations, and peri-implant infections.

5. deepblue.lib.umich.edu deepblue.lib.umich.edu/handle/2027.42/194192

Evaluation of the effectiveness of an amnion-chorion ... This randomized, controlled, blinded clinical trial included 30 patients who required anterior tooth extraction followed by dental implant placement.

6. zimvie.com zimvie.com/content/dam/zimvie-corporate/en/dental/literature/zv0040/zv0040_zimvie_biomaterials_portfolio_brochure_final_secured.pdf

Biomaterials Biotivity™ A/C Plus Membrane ... Ridge preservation and augmentation using regenerative materials to enhance implant predictability and esthetics.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092438/

Efficacy of biologics for alveolar ridge preservation ... The use of biologics may be indicated for alveolar ridge preservation (ARP) and reconstruction (ARR), and implant site development (ISD).