Collagen Membranes for Bone Regeneration

Overseen By Andrea Ravida, DDS, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrea Ravida

Disqualifiers: Gingival pathologies, Uncontrolled chronic diseases, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three different collagen membranes lasts the longest in dental and oral surgery. These membranes aid healing and tissue growth, and identifying the most durable one can enhance treatment plans. Researchers will place these membranes near participants' upper back teeth and monitor their breakdown over time. This study is double-blind, so neither patients nor researchers know which membrane is used. It suits adults in good health with healthy gums. As an unphased trial, it allows participants to contribute to advancements in dental care and improve future treatment options.

Do I need to stop my current medications for this trial?

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.

What prior data suggests that these collagen membranes are safe for use in dental procedures?

Research has shown that the three types of collagen membranes in the study are generally well-tolerated by people.

For the BioMend Extend membrane, studies indicate that its special structure enhances stability and compatibility with the body. This design reduces the need for additional surgeries, as the membrane breaks down slowly and safely over time.

The Jason membrane, with its simpler structure, is commonly used in dental procedures. It breaks down faster than more complex membranes but remains safe and effective. Studies have shown it works well without causing major side effects.

Lastly, the OSSIX Agile membrane uses a sugar-based process to enhance its connection with body tissue. This method demonstrated excellent safety and low reaction rates in patients.

Overall, research supports the safe use of all three collagen membranes. They are designed to aid healing and are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the different collagen membranes being studied for bone regeneration because they offer unique ways to enhance healing. The Membrane BioMend Extend is cross-linked with glutaraldehyde, which can provide greater stability and slower degradation, potentially leading to more effective bone support over time. Membrane Jason is non-cross-linked, allowing for faster integration with natural tissue, which could speed up the healing process. The Membrane OSSIX Agile utilizes ribose cross-linking, which might offer a balanced degradation rate with excellent tissue compatibility. These features could lead to improved outcomes compared to existing options, mainly non-cross-linked membranes, by either enhancing stability, integration speed, or tissue compatibility.

What evidence suggests that this trial's collagen membranes could be effective for bone regeneration?

This trial will compare the effectiveness of three different collagen membranes for bone regeneration: BioMend, Jason, and OSSIX. Research has shown that both cross-linked and non-cross-linked collagen membranes aid in bone healing and tissue growth. BioMend, a cross-linked membrane, is stronger and more tear-resistant, but studies have indicated it doesn't significantly improve bone regrowth compared to non-cross-linked membranes. The Jason membrane, which is non-cross-linked, breaks down completely in about 6 hours and is often used for dental bone and tissue repair. OSSIX, with its special ribose cross-linking, might lower the risk of exposure, potentially enhancing bone healing. All these membranes effectively support bone regrowth after surgery. Participants in this trial will be randomized to receive one of the various combinations of these membranes. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrea Ravida, DDS, MS, PhD

Principal Investigator

Program Director of the Periodontics and Implant Dentistry Department

Are You a Good Fit for This Trial?

This trial is for adults over 18 in good general and oral health, classified as ASA I or II. It's not suitable for those with uncontrolled chronic diseases, compromised immune systems, pregnant or breastfeeding individuals, or patients with gum disease.

Inclusion Criteria

Good oral health

I am generally in good health.

Exclusion Criteria

Pregnant patients

Patients who are currently breastfeeding

I have a chronic disease that is not under control or I have a weakened immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Initial Assessment

Digital intraoral impressions, clinical pictures, periodontal charts, and oral hygiene sessions conducted

1 day

1 visit (in-person)

Treatment

Placement of collagen membranes and initial evaluation

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for membrane integrity and any signs of inflammation

10 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Membrane BioMend Extend Glutaraldehyde cross-linked
• Membrane Jason MB GmbH Non-cross-linked (NCL)
• Membrane OSSIX Agile Ribose cross-linked (RCL)

Trial Overview The study compares the breakdown of three collagen membranes used in dental surgery: one non-cross-linked and two cross-linked types. Placed near upper back teeth gums, their longevity is measured to determine which lasts longer.

How Is the Trial Designed?

Group I: OSSIX - BioMend - Jason Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Group II: BioMend - OSSIX - Jason Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Group III: OSSIX - Jason - BioMend Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Group IV: BioMend - Jason - OSSIX Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Group V: Jason - OSSIX - BioMend Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Group VI: Jason - BioMend - OSSIX Active Control 3 Interventions

Possible unique ordering of the 3 different membranes to which participants may be randomized

Who Is Running the Clinical Trial?

Andrea Ravida

Lead Sponsor

Trials

2

Recruited

140+

Dentsply Sirona Inc.

Industry Sponsor

Trials

3

Recruited

180+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383682/

Efficacy of Cross-Linked Collagen Membranes for Bone ... However, clinical outcomes related to bone regeneration were not significantly different between cross-linked and non-cross-linked collagen ...

2. withpower.com withpower.com/trial/phase-bone-regeneration-3-2025-ebe20

Collagen Membranes for Bone Regeneration Research shows that both cross-linked and non-cross-linked collagen membranes are effective in guided bone regeneration, with studies indicating their ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7040903/

Selection of Collagen Membranes for Bone Regeneration Aim of this work is to provide a review on the main features, application, outcomes, and clinical employment of the different types of collagen membranes.

4. researchgate.net researchgate.net/publication/395009070_Efficacy_of_Cross-Linked_Collagen_Membranes_for_Bone_Regeneration_In_Vitro_and_Clinical_Studies

Efficacy of Cross-Linked Collagen Membranes for Bone ... These results indicate that cross-linking has comparable biocompatibility and enhances physical properties, including tear strength and ...

5. mdpi.com mdpi.com/2073-4360/8/4/115

Biodegradable Polymer Membranes Applied in Guided ... Some research showed that chemically cross-linked collagen membrane demonstrated more adverse events and insufficient bone regeneration compared to the non- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06944639

Comparative Study of Three Collagen Membranes: 1 Non- ... This study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth.

7. zimvie.com.au zimvie.com.au/en/dental/biomaterial-products/biomend-and-biomend-extend-absorbable-collagen-membrane-gl.html

BioMend® and Biomend Extend™ Membrane | Zimvie Dental ... BioMend and Biomend Extend resorbable collagen membranes eliminate second-stage surgery for membrane removal, designed to reduce wound trauma and surgical ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1742706122000800

Optimizing the bio-degradability and biocompatibility of a ... We fabricated a cross-linked collagen membrane with enhanced mechanical properties, prolonged degradation time and uncompromised biocompatibility.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12502

Membrane barriers for guided bone regeneration: An ... After 4 weeks, glutaraldehyde cross-linked collagen membranes revealed nearly complete vascularization. In contrast, sugar-based cross ...