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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200010
        • Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who received IIP with the BB technique at the Department of Oral and Maxillofacial Implantology of Shanghai Ninth People's Hospital from April 2021 to October 2023 were included. All participants provided written informed consent prior to surgical intervention.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
pre-operatively and up to 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

April 24, 2025

Study Completion (Actual)

January 22, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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