Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation

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.

Study Overview

• Status: Completed
• Conditions: Healing Wound
• Intervention / Treatment: Procedure: Socket preservation

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range: 20 to 80 years.
2. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
3. Socket should be free of infection, less than 5mm of dehiscence
4. Patients interested in implant placement following tooth extraction.

Exclusion Criteria:

1. Allergies or hypersensitivities to study related medications such as chlorhexidine.
2. Hematologic disorders/blood dyscrasias.
3. Active infectious diseases of any kind.
4. Liver or kidney dysfunction/failure.
5. Uncontrolled diabetes (HbA1c > 8).
6. Active cancer treatment - such as active chemotherapy or radiation therapy.
7. Taking medications that will affect their bone healing (for example, bisphosphonates).
8. Metabolic bone diseases that affect bone healing such as osteoporosis.
9. Pregnant or lactating women (self-reported).
10. Smoke 10 or more cigarettes per day (self-reported).
11. Poor oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Amnion-chorion membrane with collagen plug	Procedure: Socket preservation; After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.
Active Comparator: Control; Collagen plug	Procedure: Socket preservation; After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological bone density.	Histomorphometry.	4 months
Implant survival-Clinical	Clinically assessed by torque test using a torque wrench, measured in N/cm.	6 months
Implant survival-Radiographic	Radiographically assessed through any signs of radiolucency around the implant.	6 months
Esthetic restorative outcomes.	Clinical changes in hard tissue based on the PES score	6 months
Presence of bone turnover proteins.	Immunohistochemistry.	4 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Muhammad Saleh, BDS, MSD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HUM00208140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No