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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 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 durability and ability to support bone growth over time. Additionally, cross-linked collagen membranes have demonstrated resistance to degradation and low toxicity, making them suitable for bone regeneration applications. ^{1 2 3 4 5}

Is it safe to use collagen membranes for bone regeneration in humans?

Studies on collagen membranes, including those cross-linked with chemicals like glutaraldehyde, show no signs of inflammation or toxicity in animal models, suggesting they are generally safe for use in humans. ^{2 4 6 7 8}

How is the treatment with collagen membranes for bone regeneration different from other treatments?

This treatment uses different types of collagen membranes, including those that are cross-linked (chemically bonded to enhance durability) and non-cross-linked, which can affect how long they last and how well they support new bone growth. The use of ribose cross-linked membranes is unique as it may reduce the risk of membrane exposure, which can improve bone regeneration outcomes. ^{2 4 6 9 10}

What is the purpose of this trial?

This study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth. These membranes are often used in dental and oral surgery to help with healing and tissue growth. The goal is to find out if one membrane lasts longer than the others, which may help doctors choose the best option for different procedures. In this study, the membranes will be placed in the mouth in a specific area near the gums of the upper back teeth. The study is designed so that neither the patients nor the researchers evaluating the results will know which membrane is which (this is called a double-blind study). Over time, researchers will measure how much each membrane has broken down. This information may help improve treatment planning and patient outcomes in dental care.

Research Team

Andrea Ravida, DDS, MS, PhD

Principal Investigator

Program Director of the Periodontics and Implant Dentistry Department

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Use of a new cross-linked collagen membrane for the treatment of peri-implant dehiscence defects: a randomised controlled double-blinded clinical trial. [2021]

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

Cross-linked and non-cross-linked collagen barrier membranes disintegrate following surgical exposure to the oral environment: a histological study in the cat. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Guided bone regeneration using 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDC)-cross-linked type-I collagen membrane with biphasic calcium phosphate at rabbit calvarial defects. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Long-term bio-degradation of cross-linked and non-cross-linked collagen barriers in human guided bone regeneration. [2008]

5. Denmark pubmed.ncbi.nlm.nih.gov

Long-term outcomes of simultaneous guided bone regeneration using native and cross-linked collagen membranes after 8 years. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Distinctive bone regeneration of calvarial defects using biphasic calcium phosphate supplemented ultraviolet-crosslinked collagen membrane. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of 1-Ethyl-3-(3-Dimethylaminopropyl) Carbodiimide Cross-Linked Collagen Membranes for Guided Bone Regeneration in Beagle Dogs. [2020]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Biological effects of a porcine-derived collagen membrane on intrabony defects. [2021]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparative study of two collagen membranes for guided tissue regeneration therapy in periodontal intrabony defects: a randomized clinical trial. [2021]

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

Evaluation of Premature Membrane Exposure and Early Healing in Guided Bone Regeneration of Peri-Implant Dehiscence and Fenestration Defects With a Slowly Resorbing Porcine Collagen Ribose Cross-Linked Membrane: A Consecutive Case Series. [2020]