Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2025
CompletedMarch 25, 2025
March 1, 2025
2.2 years
October 7, 2022
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical alveolar ridge dimension changes
Clinically measured alveolar ridge dimension changes in mm using calibers
4 months
Digital alveolar ridge dimension changes
Digitally measured alveolar ridge dimension changes in mm2 using CBCT
4 months
Secondary Outcomes (5)
Histological bone density.
4 months
Presence of bone turnover proteins.
4 months
Implant survival-Clinical
6 months
Implant survival-Radiographic
6 months
Esthetic restorative outcomes.
6 months
Study Arms (2)
Test
EXPERIMENTALAmnion-chorion membrane with collagen plug
Control
ACTIVE COMPARATORCollagen plug
Interventions
After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Saleh, BDS, MSD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Periodontics and Oral Medicine
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 24, 2022
Study Start
November 16, 2022
Primary Completion
February 14, 2025
Study Completion
February 14, 2025
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share