The "Open Wound Bone Augmentation Concept" with Amnion-Chorion Membrane
NCT ID: NCT05013580
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-10-08
2023-05-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Muhammad Saleh
Clinical Assistant Professor
Principal Investigators
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Muhammad Saleh, BDS, MSD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00161016
Identifier Type: -
Identifier Source: org_study_id
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