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Amnion-Chorion Membrane for Wound Healing
N/A
Waitlist Available
Led By Muhammad Saleh, BDS, MSD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new type of plug helps bones heal better than standard plugs. #bonehealing
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort at the site of surgery, swelling or bruising around the area where the tooth was extracted and treated with membranes and plugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alveolar ridge
Alveolar ridge
Secondary study objectives
Esthetic restorative outcomes.
Osteopenia
Implant survival-Clinical
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TestExperimental Treatment1 Intervention
Amnion-chorion membrane with collagen plug
Group II: ControlActive Control1 Intervention
Collagen plug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Socket preservation
2019
Completed Phase 4
~50
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,861 Previous Clinical Trials
6,440,994 Total Patients Enrolled
4 Trials studying Wound Healing
279 Patients Enrolled for Wound Healing
Muhammad Saleh, BDS, MSDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood disorder.I am currently undergoing chemotherapy or radiation therapy.I do not have any active infections.My liver or kidneys are not working properly.I am on medication that could affect bone healing.My surgical wound is not infected and has minimal opening.I am between 20 and 80 years old.My diabetes is not under control (HbA1c > 8).I need a tooth removed due to decay, gum disease, breakage, or it can't be fixed.I am considering getting a dental implant after tooth removal.I have a bone condition like osteoporosis that affects healing.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.