Immediate Implant With Bone Graft
Conditions
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.
Interventions
PROCEDUREBone barrier technique
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.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mid-facial gingival change | pre-operatively and up to 1-year | Changes in the length of this perpendicular line over time were calculated to determine soft tissue stability. |
Countries
China
Outcome results
None listed