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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

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+