Guided Bone RegenerationNCT07918131
Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
A study testing PEEK barrier membrane in people with Guided Bone Regeneration, run by Fuming He.
Trial summary
1. Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for the reconstruction of hard-tissue defects in implant dentistry. Terheyden classified bone defects into four types according to the spatial relationship between the defect and the intended implant site. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- PEEK barrier membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years, in good general health or with mild and controllable systemic diseases, and capable of tolerating implant surgery.
- Patients with at least one missing tooth, whose bone defect at the edentulous site is classified as type 2/4, 3/4 or 4/4 according to the Terheyden classification.
- If bilateral bone augmentation is required, only one side will be randomly selected for inclusion in this study.
- The tooth at the surgical site has been extracted for at least 3 months, and the site is surgically naive.
- Sufficient soft tissue contour for staged bone augmentation, including a keratinized gingiva width of at least 2 mm.
- All patients undergo bone grafting supported by a digitally fabricated PEEK biological barrier followed by implant placement.
- Good oral hygiene status.
- Patients are able to understand and actively cooperate with the treatment protocol and have signed the informed consent form.
Who cannot join
- Pregnancy.
- Smoking more than 10 cigarettes per day.
- Subjects with alcohol abuse or chronic substance misuse.
- Long-term use of medications that interfere with bone formation.
- Presence of physical deformities that may compromise implant surgery.
- A history of local radiotherapy.
Show all 10Show fewer
- Patients with immunodeficiency, including those with HIV infection.
- Local inflammation, including untreated periodontitis.
- Extensive metallic restorations adjacent to the bone augmentation site.
- Oral mucosal disorders, such as oral lichen planus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for the reconstruction of hard-tissue defects in implant dentistry. Terheyden classified bone defects into four types according to the spatial relationship between the defect and the intended implant site. Among these, type 2/4, 3/4, and 4/4 are recommended to be managed with a staged protocol: bone augmentation first, followed by dental implant placement. The selection of barrier membranes for GBR depends on the size of the bone defect, and severe three-dimensional bone deficiencies require additional mechanical support. The digitally fabricated PEEK biological barrier is a product of the world's first digital PEEK bone augmentation system newly developed by Kangtuo Medical Group in 2026. It enables predictable bone gain and contour reconstruction, adapts to irregularly shaped bone defects, and provides complete cell exclusion as well as full soft-tissue isolation without the need for an overlying membrane. The system supports full-workflow planning and clinician-driven design. Being radiolucent, it facilitates sequential observation of bone remodeling, and the device is also easy to retrieve. Nevertheless, its clinical performance following GBR in severe bone defect sites remains to be further evaluated.
- Research objective: To evaluate the bone stability and soft tissue healing outcomes following guided bone regeneration (GBR) using a digital PEEK biological barrier in sites with severe bone defects. This study aims to provide evidence based references for clinicians when selecting barrier membranes, so as to facilitate optimal clinical decision making for bone augmentation.
- Study design and methods: Design type: multicentral prospective clinical study. Study duration: 3 years. Start time: From the date of adoption of ethics. End time: 2029. For all included patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 6-8 months postoperatively.
Read the detailed description
- Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for the reconstruction of hard-tissue defects in implant dentistry. Terheyden classified bone defects into four types according to the spatial relationship between the defect and the intended implant site. Among these, type 2/4, 3/4, and 4/4 are recommended to be managed with a staged protocol: bone augmentation first, followed by dental implant placement. The selection of barrier membranes for GBR depends on the size of the bone defect, and severe three-dimensional bone deficiencies require additional mechanical support. The digitally fabricated PEEK biological barrier is a product of the world's first digital PEEK bone augmentation system newly developed by Kangtuo Medical Group in 2026. It enables predictable bone gain and contour reconstruction, adapts to irregularly shaped bone defects, and provides complete cell exclusion as well as full soft-tissue isolation without the need for an overlying membrane. The system supports full-workflow planning and clinician-driven design. Being radiolucent, it facilitates sequential observation of bone remodeling, and the device is also easy to retrieve. Nevertheless, its clinical performance following GBR in severe bone defect sites remains to be further evaluated.
- Research objective: To evaluate the bone stability and soft tissue healing outcomes following guided bone regeneration (GBR) using a digital PEEK biological barrier in sites with severe bone defects. This study aims to provide evidence based references for clinicians when selecting barrier membranes, so as to facilitate optimal clinical decision making for bone augmentation.
- Study design and methods: Design type: multicentral prospective clinical study. Study duration: 3 years. Start time: From the date of adoption of ethics. End time: November 2029. All patients who meet the inclusion criteria at seven study centers will be recruited starting from the date of ethical approval. Each center plans to enroll 2-6 participants. Patients with severe bone defects are screened via pre-implant radiographic examinations for eligibility. All subjects provide written informed consent prior to enrollment in the clinical study. Baseline information including sex, age, and missing tooth position is recorded for all participants. Routine pre-implant assessments are performed at baseline (T0), consisting of radiographic examinations (panoramic radiograph and CBCT), intraoral examination, and pre-surgical intraoral scanning. Based on the intraoral scan and CBCT datasets, the designer reconstructs the original model and simulates the crown contour after bone graft placement, then designs and fabricates the customized PEEK biological barrier. All surgical procedures are performed by one experienced clinician at each participating center. Immediately after surgery (T1), CBCT is obtained to evaluate vertical and horizontal bone augmentation. Suture removal and intraoral scanning are conducted at 2 weeks post GBR to document soft tissue contour, together with patient satisfaction assessed using a visual analogue scale (VAS). At 6-8 months after GBR (T2), intraoral scanning and CBCT are performed to verify whether the augmented bone volume is adequate for implant placement. Subsequently, the PEEK biological barrier is removed, and implants with appropriate diameter and length are inserted. The collected data are analyzed to evaluate bone stability and soft tissue healing outcomes following GBR using the digitally fabricated PEEK biological barrier in sites with severe bone defects.
- Conditions
- Guided Bone Regeneration
- Being tested
- PEEK barrier membrane
- Keywords
- Severe bone defect, guided bone regeneration, Peek barrier membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK barrier membraneDevice
Implantation of a PEEK biological barrier during guided bone regeneration in the area of severe bone deficiency
| Study group | Role | What they receive |
|---|---|---|
| PEEK barrier membrane | Experimental | Not described Receives: Device: PEEK barrier membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone augmentation
The cone beam computed tomography (CBCT) data from the two time points (on the day of the initial consultation (T0), and six-eight months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. The volumes of the 6-month bone increment can be accessed from the properties menu.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (7)
Bone resorption
The cone beam computed tomography (CBCT) data from the three time points (on the day of the initial consultation (T0), immediately after surgery (T1) and six months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T1 and T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. V1 (volumes of the immediate bone increment) and V2 (volumes of the 6-month bone increment) can be accessed from the properties menu. The resorption rate of bone increment, denoted as RV, can be calculated by utilizing the formula (V1 -V2)/V1.
Measured: From enrollment to the end of treatment at 6 months
pseudo-periosteum
A periodontal probe was used to measure the pseudo-periosteal thickness at the buccal, palatal, and alveolar crest sites around each implant.
Measured: At the time of implant placement in the second phase surgery
Soft tissue healing
Soft tissue healing condition recorded by oral scanning and photography in 2 weeks before and 2 weeks after surgery and 6-8 months after surgery.
Measured: From enrollment to the end of treatment at 6 months
Bone height change
The STL files of the preoperative bone defect region, immediate postoperative augmented bone, and bone at 6 months postoperatively were imported into the E-3D implant design software with a unified coordinate system. These files were then registered to the CBCT datasets, and the implant site was planned. Using the long axis of the virtually designed implant, an inspection plane was created in the buccolingual direction, from which two-dimensional measurements were acquired. The STL models of bone contours at the three time points were visualized in 2D within the E-3D software. The linear distance between T0 and T2 was recorded as the augmented bone height (H1), and the linear distance between T1 and T2 was recorded as the bone height after six months of healing (H2). The difference between H1 and H2 represented the bone height resorption over the six-month healing period.
Measured: From enrollment to the end of treatment at 6 months
Bone width change
The STL files of the preoperative bone defect, immediate postoperative augmented bone, and bone at 6 months postoperatively were imported into the E-3D implant design software under a unified coordinate system. These files were then registered to the CBCT datasets, and the implant site was virtually planned. Using the long axis of the designed implant, an inspection plane was generated in the buccolingual direction for two-dimensional measurement acquisition. The STL models of bone contours at the three time points were visualized in 2D within the E-3D software. For horizontal bone defects, a line perpendicular to the long axis of the designed implant was drawn at the level of the implant platform. Three segment lengths were captured to represent the bone width at baseline, immediately after surgery, and at 6 months postoperatively, respectively. Pairwise subtraction of these values yielded the immediate width gain, the width gain at 6 months, and the width resorption.
Measured: From enrollment to the end of treatment at 6 months
Biological complication
Logging PEEK barrier exposure, infection, bone Implantation Failure, etc.
Measured: From enrollment to the end of treatment at 6 months
Patient satisfaction
postoperative satisfaction through VAS assessment
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start3 Nov 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuming He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuming He, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918131
- Sponsor's protocol ID
- DHZhejiangU-2026(155)
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
- ClinicalTrials.gov ID
- NCT07918131
- Acronym / sponsor ID
- DHZhejiangU-2026(155)
- Conditions
- Guided Bone Regeneration
- Keywords
- Severe bone defect, guided bone regeneration, Peek barrier membrane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fuming HeUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 5 Nov 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.
- Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for the reconstruction of hard-tissue defects in implant dentistry. Terheyden classified bone defects into four types according to the spatial relationship between the defect and the intended implant site. Among these, type 2/4, 3/4, and 4/4 are recommended to be managed with a staged protocol: bone augmentation first, followed by dental implant placement. The selection of barrier membranes for GBR depends on the size of the bone defect, and severe three-dimensional bone deficiencies require additional mechanical support. The digitally fabricated PEEK biological barrier is a product of the world's first digital PEEK bone augmentation system newly developed by Kangtuo Medical Group in 2026. It enables predictable bone gain and contour reconstruction, adapts to irregularly shaped bone defects, and provides complete cell exclusion as well as full soft-tissue isolation without the need for an overlying membrane. The system supports full-workflow planning and clinician-driven design. Being radiolucent, it facilitates sequential observation of bone remodeling, and the device is also easy to retrieve. Nevertheless, its clinical performance following GBR in severe bone defect sites remains to be further evaluated.
- Research objective: To evaluate the bone stability and soft tissue healing outcomes following guided bone regeneration (GBR) using a digital PEEK biological barrier in sites with severe bone defects. This study aims to provide evidence based references for clinicians when selecting barrier membranes, so as to facilitate optimal clinical decision making for bone augmentation.
- Study design and methods: Design type: multicentral prospective clinical study. Study duration: 3 years. Start time: From the date of adoption of ethics. End time: 2029. For all included patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 6-8 months postoperatively.
Detailed description
- Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for the reconstruction of hard-tissue defects in implant dentistry. Terheyden classified bone defects into four types according to the spatial relationship between the defect and the intended implant site. Among these, type 2/4, 3/4, and 4/4 are recommended to be managed with a staged protocol: bone augmentation first, followed by dental implant placement. The selection of barrier membranes for GBR depends on the size of the bone defect, and severe three-dimensional bone deficiencies require additional mechanical support. The digitally fabricated PEEK biological barrier is a product of the world's first digital PEEK bone augmentation system newly developed by Kangtuo Medical Group in 2026. It enables predictable bone gain and contour reconstruction, adapts to irregularly shaped bone defects, and provides complete cell exclusion as well as full soft-tissue isolation without the need for an overlying membrane. The system supports full-workflow planning and clinician-driven design. Being radiolucent, it facilitates sequential observation of bone remodeling, and the device is also easy to retrieve. Nevertheless, its clinical performance following GBR in severe bone defect sites remains to be further evaluated.
- Research objective: To evaluate the bone stability and soft tissue healing outcomes following guided bone regeneration (GBR) using a digital PEEK biological barrier in sites with severe bone defects. This study aims to provide evidence based references for clinicians when selecting barrier membranes, so as to facilitate optimal clinical decision making for bone augmentation.
- Study design and methods: Design type: multicentral prospective clinical study. Study duration: 3 years. Start time: From the date of adoption of ethics. End time: November 2029. All patients who meet the inclusion criteria at seven study centers will be recruited starting from the date of ethical approval. Each center plans to enroll 2-6 participants. Patients with severe bone defects are screened via pre-implant radiographic examinations for eligibility. All subjects provide written informed consent prior to enrollment in the clinical study. Baseline information including sex, age, and missing tooth position is recorded for all participants. Routine pre-implant assessments are performed at baseline (T0), consisting of radiographic examinations (panoramic radiograph and CBCT), intraoral examination, and pre-surgical intraoral scanning. Based on the intraoral scan and CBCT datasets, the designer reconstructs the original model and simulates the crown contour after bone graft placement, then designs and fabricates the customized PEEK biological barrier. All surgical procedures are performed by one experienced clinician at each participating center. Immediately after surgery (T1), CBCT is obtained to evaluate vertical and horizontal bone augmentation. Suture removal and intraoral scanning are conducted at 2 weeks post GBR to document soft tissue contour, together with patient satisfaction assessed using a visual analogue scale (VAS). At 6-8 months after GBR (T2), intraoral scanning and CBCT are performed to verify whether the augmented bone volume is adequate for implant placement. Subsequently, the PEEK biological barrier is removed, and implants with appropriate diameter and length are inserted. The collected data are analyzed to evaluate bone stability and soft tissue healing outcomes following GBR using the digitally fabricated PEEK biological barrier in sites with severe bone defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEK barrier membrane | Experimental | Device: PEEK barrier membrane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 80 years, in good general health or with mild and controllable systemic diseases, and capable of tolerating implant surgery.
- Patients with at least one missing tooth, whose bone defect at the edentulous site is classified as type 2/4, 3/4 or 4/4 according to the Terheyden classification.
- If bilateral bone augmentation is required, only one side will be randomly selected for inclusion in this study.
- The tooth at the surgical site has been extracted for at least 3 months, and the site is surgically naive.
- Sufficient soft tissue contour for staged bone augmentation, including a keratinized gingiva width of at least 2 mm.
Key exclusion criteria (10 listed)
- Pregnancy.
- Smoking more than 10 cigarettes per day.
- Subjects with alcohol abuse or chronic substance misuse.
- Long-term use of medications that interfere with bone formation.
- Presence of physical deformities that may compromise implant surgery.
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 |
|---|---|---|
| PEEK barrier membraneImplantation of a PEEK biological barrier during guided bone regeneration in the area of severe bone deficiency | Device | PEEK barrier membrane |
Primary outcome
Bone augmentation
Time frame: From enrollment to the end of treatment at 6 months
The cone beam computed tomography (CBCT) data from the two time points (on the day of the initial consultation (T0), and six-eight months after the first surgery (T2) ) were obtained and imported into Mimics Medical software. For each patient, the jaw models at T2 were aligned separately with the jaw model at T0 using point and global registration. After registration and cutting of the digital models, , a Boolean subtraction operation was conducted by subtracting the pre-operative bone segment from the bone segment at 6 months postoperatively to obtain a 6-month postoperative bone increment model. The volumes of the 6-month bone increment can be accessed from the properties menu.
7 secondary outcomes
Bone resorption
Time frame: From enrollment to the end of treatment at 6 months
pseudo-periosteum
Time frame: At the time of implant placement in the second phase surgery
Soft tissue healing
Time frame: From enrollment to the end of treatment at 6 months
Bone height change
Time frame: From enrollment to the end of treatment at 6 months
Bone width change
Time frame: From enrollment to the end of treatment at 6 months
Biological complication
Time frame: From enrollment to the end of treatment at 6 months
Patient satisfaction
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK barrier membrane in people with Guided Bone Regeneration, run by Fuming He.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuming He (+8613516817697, hfm@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone augmentation (time frame: From enrollment to the end of treatment at 6 months). 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 5 Nov 2026.