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

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.

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Key information

Conditions

Horizontal Ridge Deficiency

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided Bone Regeneration (GBR)

Procedure

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.

Other names: Horizontal bone augmentation (HBA)

Primary outcomes

Ridge width changes

Time frame: 6 months

Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Aug 19, 2021
Registry last updated: Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed