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

Horizontal Ridge Deficiency Clinical Trial

Official title:

The "Open Wound Bone Augmentation Concept" With Amnion-Chorion Membrane: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013580
• Other study ID #: HUM00161016
• Status: Completed
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: May 4, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Horizontal Ridge Deficiency

Intervention

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.

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	Ridge width changes	Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements	6 months