Bone Barrier Technique for Compromised Immediate Implants

NCT07415265 | Completed

• 1 other identifier: SH9H-2025-604-imp
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immediate Implant With Bone Graft

Outcome Measures

Primary Outcomes (1)

• mid-facial gingival change

  Changes in the length of this perpendicular line over time were calculated to determine soft tissue stability.

  pre-operatively and up to 1-year

Interventions

Bone barrier technique PROCEDURE

To reconstruct the buccal dehiscence, an allogenic cortical bone lamina (1 × 8 × 12 mm; Hubei Lianjie Biological Materials Co., Ltd., China) was employed using the novel BB technique. The specific tunnel preparation approach was then selected based on the defect morphology. A intrasulcular approach was utilized when the maximum width of the buccal bone dehiscence was less than half of the mesiodistal distance of the interdental space, whereas a vestibular approach was chosen when the defect width exceeded this threshold to minimize tension. Regardless of the approach, the tunnel was extended at least 2 mm apically and mesiodistally beyond the bone defect margins. Finally, the bone lamina was trimmed to match the defect dimensions and inserted into the prepared subperiosteal envelope, where it was stabilized between the residual bone and the elevated periosteum to prevent displacement.

Also known as: Connective tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200010, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: April 12, 2021
• Primary Completion: April 24, 2025
• Study Completion: January 22, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)