30 Participants NeededMy employer runs this trial

Collagen Membrane for Tooth Extractions

DR
CS
Overseen ByCarla Sanchez, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance jaw healing after tooth extraction. Researchers aim to determine if adding a special collagen membrane (resorbable collagen membrane, InterCollagen® Guide) to a bone graft can preserve the jawbone's shape and size for future dental implants. Participants will receive either the bone graft alone or the bone graft with the collagen membrane to assess which option is more effective. This trial targets individuals who need an upper tooth extracted and have more than half of the outer bone missing, while neighboring teeth remain intact. As an unphased trial, it offers participants the chance to contribute to innovative dental research that could improve future treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking corticosteroids, IV bisphosphonates, or immunosuppressive drugs, you may not be eligible to participate.

What prior data suggests that this method is safe for ridge preservation after tooth extraction?

Research has shown that using a dissolvable collagen membrane, like the InterCollagen® Guide, is generally safe for dental procedures. Studies have found that when combined with bone grafts, this membrane helps maintain the jawbone's integrity after tooth removal. This approach aids healing and prevents bone loss, which is crucial for future dental implants.

The collagen membrane used in this treatment is derived from pig tissue and is designed to naturally dissolve in the body. This process helps the jawbone retain its shape and size. Past studies indicate that patients generally tolerate this material well.

While any procedure can involve risks, such as swelling or infection, these are usually manageable. Overall, using a dissolvable collagen membrane in dental surgeries has proven to be safe.12345

Why are researchers excited about this trial?

Researchers are excited about the use of a collagen membrane for alveolar ridge preservation after tooth extractions because it offers a potential improvement over traditional bone grafts alone. Unlike standard treatments that rely solely on bone graft materials, this approach uses a resorbable collagen membrane (InterCollagen® Guide) to enhance the healing process. This membrane acts as a barrier, promoting better integration and stability of the graft by protecting it from soft tissue infiltration. The combination of bone graft and collagen membrane could lead to more predictable outcomes in maintaining the bone structure after tooth extraction, which is a key benefit for patients needing dental restorations.

What evidence suggests that adding a collagen membrane to ABCC is effective for ridge preservation after tooth extraction?

This trial will compare two approaches for alveolar ridge preservation after tooth extraction. The control group will receive a bone graft using ABCC alone, while the test group will receive a bone graft combined with a resorbable collagen membrane (InterCollagen® Guide). Studies have shown that using a dissolvable collagen membrane with a special bone-collagen mix effectively maintains the jawbone's shape and size after tooth removal. Research indicates that this combination significantly reduces bone loss, preserving the width and height of the jawbone better than the bone-collagen mix alone. A review found that adding a collagen membrane can decrease bone loss by about 2.37 mm. This method helps ensure the jawbone remains healthy for future dental implants. Overall, evidence suggests that combining the membrane with the graft offers better bone protection compared to the graft alone.12346

Who Is on the Research Team?

DR

Debora R Dias, DDS, PhD

Principal Investigator

University of Pittsburgh, Department of Periodontics and Preventive Dentistry

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who need a single upper tooth removed, have significant bone loss on the cheek side of that tooth, healthy neighboring teeth, and are generally in good health. Participants must be able to attend follow-up visits.

Inclusion Criteria

I am between 18 and 80 years old.
I have at least 50% bone loss in my cheek-side jawbone as shown by a dental scan.
I need to have a single-rooted upper tooth removed.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tooth extraction and receive either ABCC alone or ABCC with a collagen membrane for ridge preservation

1 day
1 visit (in-person)

Healing

Participants heal after the ridge preservation procedure, with follow-up assessments for healing quality and complications

4 months
Multiple visits (in-person) at 1 week, 2 weeks, 1 month, and 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including implant placement and assessment of bone and soft tissue healing

4 months
1 visit (in-person) for implant placement

What Are the Treatments Tested in This Trial?

Interventions

  • Alveolar ridge preservation with ABCC
  • Resorbable collagen membrane (InterCollagen® Guide)

Trial Overview

The study compares two ways to preserve jawbone after tooth removal: using an anorganic bone-collagen graft alone or with a dissolvable collagen membrane. Patients are randomly assigned to one group and healing is checked over about four months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Test group (bone graft + collagen membrane)Experimental Treatment3 Interventions
Group II: Control group (bone graft only)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Debora Dias

Lead Sponsor

SigmaGraft Inc.

Collaborator

Trials
1
Recruited
50+

Citations

Changes of the Alveolar Bone Ridge Using Bone Mineral ...

The use of bone mineral grafts in combination with resorbable collagen barriers provides greater preservation of the alveolar ridge, although more clinical ...

New Technique of Double-Layer Alveolar Ridge Preservation ...

The objective of this study was to evaluate the clinical efficacy of a new double-layer ARP technique that additionally covers a collagen matrix at the top ...

Effect of Collagen Membrane on Ridge Preservation

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge ...

Ridge Preservation research: What the evidence shows

Ridge preservation evidence confirms significant protection of ridge dimensions.1-3; Xenogeneic bone substitutes combined with a resorbable membrane help ...

Effect of Collagen Membrane on Ridge Preservation

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge ...

Dental Barrier Membrane Guided Tissue Regeneration

Studies comparing alveolar Ridge Preservation procedures with tooth extraction alone that reported quantitative outcomes for hard tissue ...