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

Sponsor
University of Michigan (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05013580
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
21.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Guided bone regeneration (GBR)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The "Open Wound Bone Augmentation Concept" With Amnion-Chorion Membrane: A Randomized Controlled Trial
Actual Study Start Date :
Oct 8, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ridge width changes [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan School of Dentistry Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Shan-Huey Yu, DDS, MS, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shan-Huey Yu, Clinical Assistant Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05013580
    Other Study ID Numbers:
    • HUM00161016
    First Posted:
    Aug 19, 2021
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Nov 22, 2021