- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415265
Bone Barrier Technique for Compromised Immediate Implants
A Novel Bone Barrier Technique for Immediate Implant Placement With Severe Buccal Bone Dehiscence: A 1-year Case Series
The goal of this clinical study is to learn whether a new surgical method, called the Bone Barrier technique, can help improve outcomes when placing dental implants immediately after tooth removal in the front upper jaw. This study focuses on people who have a large loss of bone on the front side of the tooth socket, a condition that can make implant treatment difficult.
The main questions this study aims to answer are:
Can this technique help keep the implant stable and working after surgery? Can it help maintain the bone and gingiva shape around the implant? How satisfied are participants with the appearance and function of the implant after treatment?
This study includes adults who need an immediate dental implant in the front upper jaw and have severe bone loss on the front side of the socket. All participants receive the same surgical treatment as part of their routine dental care.
During the procedure, the surgeon places a dental implant immediately after tooth removal. A thin bone plate from donated human bone is used to rebuild the missing front bone wall, and a small piece of gum tissue is added to support the soft tissue. The surgery is done using a minimally invasive approach.
Participants will:
Receive the Bone Barrier implant procedure as part of their treatment Return for follow-up visits for routine dental examinations and CBCT imaging Be asked to rate their satisfaction with the appearance and function of the implant on a simple scale from zero to ten
This study aims to help dentists better understand whether this approach may be a useful option for treating difficult cases that involve significant bone loss in the esthetic zone.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200010
- Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) Presence of a non-restorable anterior tooth (canine to canine) due to severe trauma, root fracture, or endodontic failure, with healthy and natural adjacent teeth. (2) With an intact buccal gingival profile. (3) Presence of a severe buccal bone dehiscence defined as a vertical defect height of >5 mm following extraction. (4) Sufficient residual native bone volume (≥4 mm apical to the root apex) to ensure primary implant stability.
Exclusion Criteria:
(1) Uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension and coronary heart disease), untreated periodontitis, acute or active infection around the surgical site, or any other conditions contraindicating oral surgery. (2) Heavy smoking habits (>10 cigarettes per day). (3) Parafunctional habits (e.g., severe bruxism). (4) Lack of compliance.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mid-facial gingival change
Time Frame: pre-operatively and up to 1-year
|
Changes in the length of this perpendicular line over time were calculated to determine soft tissue stability.
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pre-operatively and up to 1-year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SH9H-2025-604-imp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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