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

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

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.

Study Overview

• Status: Completed
• Conditions: Horizontal Ridge Deficiency
• Intervention / Treatment: Procedure: Guided bone regeneration (GBR)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Wound; 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.	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.; Other Names: Horizontal bone augmentation (HBA)
Active Comparator: Closed Wound; 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.	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.; Other Names: Horizontal bone augmentation (HBA)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Muhammad Saleh, BDS, MSD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HUM00161016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No