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

NCT05013580 | Completed

• 1 other identifier: HUM00161016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (1)

• Ridge width changes

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

  6 months

Study Arms (2)

Open Wound

EXPERIMENTAL

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)

Closed Wound

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Horizontal bone augmentation (HBA)

Closed Wound; Open Wound

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Muhammad Saleh, BDS, MSD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: October 8, 2021
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: September 25, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)