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

Healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05592158
• Other study ID #: HUM00208140
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing Wound

Intervention

Procedure:
• Socket preservation
After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical alveolar ridge dimension changes	Clinically measured alveolar ridge dimension changes in mm using calibers	4 months
Primary	Digital alveolar ridge dimension changes	Digitally measured alveolar ridge dimension changes in mm2 using CBCT	4 months
Secondary	Histological bone density.	Histomorphometry.	4 months
Secondary	Presence of bone turnover proteins.	Immunohistochemistry.	4 months
Secondary	Implant survival-Clinical	Clinically assessed by torque test using a torque wrench, measured in N/cm.	6 months
Secondary	Implant survival-Radiographic	Radiographically assessed through any signs of radiolucency around the implant.	6 months
Secondary	Esthetic restorative outcomes.	Clinical changes in hard tissue based on the PES score	6 months