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

University of Michigan

Status: Completed

Conditions: Healing Wound

Treatments: Procedure: Socket preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT05592158

HUM00208140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Test

Experimental group

Description:

Amnion-chorion membrane with collagen plug

Treatment:

Procedure: Socket preservation

Control

Active Comparator group

Description:

Collagen plug

Treatment:

Procedure: Socket preservation