NCT05013580

The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane

The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.

Detailed description

Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal. Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals. 20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.

Conditions

• Horizontal Ridge Deficiency

Interventions

Type	Name	Description
PROCEDURE	Guided bone regeneration (GBR)	Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures.

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2021-08-19
• Last updated: 2024-09-25

Locations

1 site across 1 country: United States