Amnion-Chorion Membrane for Wound Healing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Bisphosphonates, others

Disqualifiers: Infectious diseases, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-extraction

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid bone healing after tooth extraction. Researchers aim to determine if adding an amnion-chorion membrane (a natural tissue layer) to the usual collagen plug enhances bone growth more than the collagen plug alone. This process, known as socket preservation, targets individuals needing tooth extraction due to decay or damage and considering an implant afterward. Participants should have a healthy socket (the empty space after a tooth is removed) and no major health or bone-healing issues. As an unphased trial, this study allows participants to contribute to innovative dental research that could improve future treatment options.

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

The trial requires that you do not take medications that affect bone healing, like bisphosphonates. If you're on such medications, you may need to stop them to participate.

What prior data suggests that the amnion-chorion membrane is safe for wound healing?

Research has shown that the amnion-chorion membrane is generally safe for aiding wound healing. In a small study with five patients who had chronic wounds, a dried version of this membrane caused no negative side effects, indicating it is well-tolerated. Another study compared it to a collagen dressing for healing mouth wounds and found good results without safety issues.

Although specific safety data for its use in bone formation studies is lacking, these findings from wound healing offer some reassurance about its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the amnion-chorion membrane for socket preservation in wound healing because it introduces a unique blend of biological components that support natural tissue repair. Unlike standard options like collagen plugs alone, this treatment combines an amnion-chorion membrane with a collagen plug, which may enhance the healing process by providing a rich source of growth factors and reducing inflammation. This dual approach could potentially accelerate healing and improve outcomes by creating a more conducive environment for tissue regeneration compared to traditional methods.

What evidence suggests that the amnion-chorion membrane with collagen plug is effective for wound healing?

Research has shown that an amnion-chorion membrane can enhance wound healing. Studies have found that this membrane accelerates wound closure, with up to 94.4% of treated wounds remaining closed over time. It contains substances that promote cell growth and new blood vessel formation, improving healing. Additionally, it has properties that help prevent infections. In this trial, participants in the test arm will have the amnion-chorion membrane placed on a collagen plug for socket preservation, potentially leading to better bone growth. Meanwhile, the control arm will receive only the collagen plug. ^{1 6 7 8 9}

Who Is on the Research Team?

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-80 needing tooth extraction due to decay, gum disease, fracture, or non-restorable conditions and interested in dental implants. They must have a healthy socket with minimal damage and no infection. Exclusions include liver/kidney issues, uncontrolled diabetes, pregnancy/breastfeeding, blood disorders, active infections or cancer treatments, poor oral hygiene, heavy smokers (10+ cigarettes/day), allergies to study meds like chlorhexidine.

Inclusion Criteria

My surgical wound is not infected and has minimal opening.

I am between 20 and 80 years old.

I need a tooth removed due to decay, gum disease, breakage, or it can't be fixed.

Exclusion Criteria

I have a blood disorder.

Allergies or hypersensitivities to study related medications such as chlorhexidine

Smoke 10 or more cigarettes per day (self-reported)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tooth extraction followed by bone grafting with or without an amnion-chorion membrane

Immediate post-extraction

Follow-up

Participants are monitored for bone formation and implant survival

6 months

Regular follow-up visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Socket Preservation

Trial Overview The study tests if adding an amnion-chorion membrane on top of the standard collagen plug used in socket preservation leads to better bone formation after tooth extraction. This could improve outcomes for patients getting dental implants following extractions.

How Is the Trial Designed?

Group I: Test Experimental Treatment 1 Intervention

Amnion-chorion membrane with collagen plug

Group II: Control Active Control 1 Intervention

Collagen plug

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9221211/

Investigating the Effects of Dehydrated Human Amnion ... These findings suggest that GFs contained in dHACM promote proliferation and migration of PDLCs and angiogenesis, which lead to enhanced periodontal healing.

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10781888/

Dehydrated human amnion/chorion membrane allograft ... Overall, 38 (71.7%) wounds presented a favourable outcome (70%–100% area reduction), with 35 (66%) completely healing over a median time of 77 ...

4. mdpi.com mdpi.com/2079-4983/14/10/531

The Preparation and Clinical Efficacy of Amnion-Derived ... The presence of antimicrobial peptides (AMPs) can positively impact surgical outcomes by reducing or preventing microbe growth and establishing biofilms during ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213909513000402

Dehydrated human amnion/chorion membrane allografts in ... Treatment with dHACM allografts promotes rapid healing of diabetic ulcers. 94.4% of wounds healed with dHACM remained closed after 9–12 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6850092/

Characterisation of dehydrated amnion chorion ... The purpose of this study is to characterise the composition of a dehydrated amnion and chorion graft and investigate how factors released from this graft ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03713073

Clinical and Histological Outcomes of Allogenic Amnion ... The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival ...

8. withpower.com withpower.com/trial/phase-wounds-and-injuries-7-2023-3578d

Amnion-Chorion Membrane for Palate Wound Healing A case series involving five patients with chronic non-healing wounds treated with dHACM reported no adverse events, suggesting it is a safe and effective ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8816783/

Sealing materials for post-extraction site: a systematic review ... The use of bone graft and coverage biomaterials during ARP has been shown to result in superior treatment outcomes compared with unassisted ...