Immediate Implant With Bone GraftNCT07415265
Bone Barrier Technique for Compromised Immediate Implants
An observational study of Immediate Implant With Bone Graft, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immediate Implant With Bone Graft
- What is being tested?
- Bone barrier technique
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 22 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oral Maxillofacial Implantology Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200010
About this study
Official title: 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:
Read more
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
- Being tested
- Bone barrier technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone barrier techniqueProcedure or surgery
Also called Connective tissue graft
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
mid-facial gingival change
Changes in the length of this perpendicular line over time were calculated to determine soft tissue stability.
Measured: pre-operatively and up to 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Apr 2021
- Primary completion24 Apr 2025
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant With Bone GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415265
- Sponsor's protocol ID
- SH9H-2025-604-imp
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Bone Barrier Technique for Immediate Implant Placement With Severe Buccal Bone Dehiscence: A 1-year Case Series
- ClinicalTrials.gov ID
- NCT07415265
- Acronym / sponsor ID
- SH9H-2025-604-imp
- Conditions
- Immediate Implant With Bone Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone barrier techniqueAlso: Connective tissue graftTo 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. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immediate Implant With Bone Graft, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mid-facial gingival change (time frame: pre-operatively and up to 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.