Amnion-Chorion Membrane for Wound Healing
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
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.
Research Team
MS
Muhammad Saleh, BDS, MSD
Principal Investigator
University of Michigan
Eligibility Criteria
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.
See 1 more
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)
See 8 more
Timeline
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
Treatment Details
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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TestExperimental Treatment1 Intervention
Amnion-chorion membrane with collagen plug
Group II: ControlActive Control1 Intervention
Collagen plug
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Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Trials
1,891
Recruited
6,458,000+
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