CompletedNot Applicable

Bone Barrier Technique for Compromised Immediate Implants

China10 participantsStarted 2021-04-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

mid-facial gingival change

Timeframe: pre-operatively and up to 1-year

Trial details

NCT IDNCT07415265

SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-24

View on ClinicalTrials.gov More Immediate Implant With Bone Graft trials