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

Not Applicable

Completed

• Conditions: Healing Wound
• Interventions: Procedure: Socket preservation

• Registration Number: NCT05592158
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-24
• Study Start: 2022-11-16
• Primary Completion: 2025-02-14
• Study Completion: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Socket preservation	Amnion-chorion membrane with collagen plug
Control	Socket preservation	Collagen plug

Primary Outcome Measures

Name	Time	Method
Clinical alveolar ridge dimension changes	4 months	Clinically measured alveolar ridge dimension changes in mm using calibers
Digital alveolar ridge dimension changes	4 months	Digitally measured alveolar ridge dimension changes in mm2 using CBCT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States