Healing WoundNCT05592158
Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
A study testing Socket preservation in people with Healing Wound, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Healing Wound
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 20 to 80 years.
- Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
- Socket should be free of infection, less than 5mm of dehiscence
- Patients interested in implant placement following tooth extraction.
Who cannot join
- Allergies or hypersensitivities to study related medications such as chlorhexidine.
- Hematologic disorders/blood dyscrasias.
- Active infectious diseases of any kind.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (HbA1c > 8).
- Active cancer treatment - such as active chemotherapy or radiation therapy.
Show all 11Show fewer
- Taking medications that will affect their bone healing (for example, bisphosphonates).
- Metabolic bone diseases that affect bone healing such as osteoporosis.
- Pregnant or lactating women (self-reported).
- Smoke 10 or more cigarettes per day (self-reported).
- Poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.
30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.
- Conditions
- Healing Wound
- Being tested
- Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Amnion-chorion membrane with collagen plug Receives: Procedure: Socket preservation |
| Control | Active comparator | Collagen plug Receives: Procedure: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical alveolar ridge dimension changes
Clinically measured alveolar ridge dimension changes in mm using calibers
Measured: 4 months
Digital alveolar ridge dimension changes
Digitally measured alveolar ridge dimension changes in mm2 using CBCT
Measured: 4 months
Secondary outcomes (5)
Histological bone density.
Histomorphometry.
Measured: 4 months
Presence of bone turnover proteins.
Immunohistochemistry.
Measured: 4 months
Implant survival-Clinical
Clinically assessed by torque test using a torque wrench, measured in N/cm.
Measured: 6 months
Implant survival-Radiographic
Radiographically assessed through any signs of radiolucency around the implant.
Measured: 6 months
Esthetic restorative outcomes.
Clinical changes in hard tissue based on the PES score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start16 Nov 2022
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Saleh, University of Michigan
- Investigators
- Muhammad Saleh, BDS, MSD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592158
- Sponsor's protocol ID
- HUM00208140
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT05592158
- Acronym / sponsor ID
- HUM00208140
- Conditions
- Healing Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.
30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: Socket preservationAmnion-chorion membrane with collagen plug |
| Control | Active comparator | Procedure: Socket preservationCollagen plug |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 20 to 80 years.
- Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
- Socket should be free of infection, less than 5mm of dehiscence
- Patients interested in implant placement following tooth extraction.
Key exclusion criteria (11 listed)
- Allergies or hypersensitivities to study related medications such as chlorhexidine.
- Hematologic disorders/blood dyscrasias.
- Active infectious diseases of any kind.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (HbA1c > 8).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socket preservationAfter tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane. | Procedure or surgery | Control, Test |
Primary outcome
Clinical alveolar ridge dimension changes
Time frame: 4 months
Clinically measured alveolar ridge dimension changes in mm using calibers
Digital alveolar ridge dimension changes
Time frame: 4 months
Digitally measured alveolar ridge dimension changes in mm2 using CBCT
5 secondary outcomes
Histological bone density.
Time frame: 4 months
Presence of bone turnover proteins.
Time frame: 4 months
Implant survival-Clinical
Time frame: 6 months
Implant survival-Radiographic
Time frame: 6 months
Esthetic restorative outcomes.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Saleh, BDS, MSD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation in people with Healing Wound, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical alveolar ridge dimension changes (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.