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

University of Michigan

Status: Completed

Conditions: Horizontal Ridge Deficiency

Treatments: Procedure: Guided bone regeneration (GBR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05013580

HUM00161016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be at least 21 years of age
• Be missing 1 to 2 back teeth in the lower jaw for at least three months
• Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
• Have enough bone height at the site

Exclusion criteria

• Currently smoke more than 10 cigarettes a day (self-reported)
• Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
• Are pregnant or are lactating (self-reported)
• Have unstable periodontal disease or other dental infection
• Have poor oral hygiene
• Have any clinical conditions that make the subject unsuitable for bone graft surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Open Wound

Experimental group

Description:

After horizontal bone grafting, 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 and will be left partially open to heal.

Treatment:

Procedure: Guided bone regeneration (GBR)

Closed Wound

Active Comparator group

Description:

After horizontal bone grafting, the wound where the graft was attached to the bone will be filled with collagen tissue and stitched closed while it heals.

Treatment:

Procedure: Guided bone regeneration (GBR)