Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects

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. 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.
2. 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.
3. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Guided Bone Regeneration
• Intervention / Treatment: Device: PEEK barrier membrane

Detailed Description

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. 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.
2. 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.
3. 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 Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuming He; Phone Number: +8613516817697; Email: hfm@zju.edu.cn
• Study Contact Backup: Name: Chang Yang; Phone Number: +8618368658928; Email: yangchang_@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged between 18 and 80 years, in good general health or with mild and controllable systemic diseases, and capable of tolerating implant surgery.
2. 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.
3. If bilateral bone augmentation is required, only one side will be randomly selected for inclusion in this study.
4. The tooth at the surgical site has been extracted for at least 3 months, and the site is surgically naive.
5. Sufficient soft tissue contour for staged bone augmentation, including a keratinized gingiva width of at least 2 mm.
6. All patients undergo bone grafting supported by a digitally fabricated PEEK biological barrier followed by implant placement.
7. Good oral hygiene status.
8. Patients are able to understand and actively cooperate with the treatment protocol and have signed the informed consent form.

Exclusion Criteria:

1. Pregnancy.
2. Smoking more than 10 cigarettes per day.
3. Subjects with alcohol abuse or chronic substance misuse.
4. Long-term use of medications that interfere with bone formation.
5. Presence of physical deformities that may compromise implant surgery.
6. A history of local radiotherapy.
7. Patients with immunodeficiency, including those with HIV infection.
8. Local inflammation, including untreated periodontitis.
9. Extensive metallic restorations adjacent to the bone augmentation site.
10. Oral mucosal disorders, such as oral lichen planus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEEK barrier membrane	Device: PEEK barrier membrane; Implantation of a PEEK biological barrier during guided bone regeneration in the area of severe bone deficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the end of treatment at 6 months
Patient satisfaction	postoperative satisfaction through VAS assessment	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.	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.	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.	From enrollment to the end of treatment at 6 months
Biological complication	Logging PEEK barrier exposure, infection, bone Implantation Failure, etc.	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Fuming He

Study record dates

Study Major Dates

• Study Start (Estimated): November 3, 2026
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: October 31, 2026
• First Submitted That Met QC Criteria: October 31, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: October 31, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: guided bone regeneration; Severe bone defect; Peek barrier membrane
• Other Study ID Numbers: DHZhejiangU-2026(155)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No