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

Not Applicable

Completed

• Conditions: Horizontal Ridge Deficiency
• Interventions: Procedure: Guided bone regeneration (GBR)

• Registration Number: NCT05013580
• Lead Sponsor: University of Michigan

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-19
• Study Start: 2021-10-08
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Wound	Guided bone regeneration (GBR)	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.
Closed Wound	Guided bone regeneration (GBR)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States