Alveolar Bone Loss* / TherapyNCT07574853
Study on Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration
A study testing Silk Fibroin-Reinforced Collagen-Based Composite Membrane in people with Alveolar Bone Loss* / Therapy, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
Based on the mechanism of intramembranous ossification of the alveolar bone, it is necessary to design a biomimetic membrane material based on the principle of GBR (Guided Bone Regeneration) to simulate the biological microenvironment of alveolar bone regeneration, promote the direct differentiation of stem cells into… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alveolar Bone Loss* / Therapy
- What is being tested?
- Silk Fibroin-Reinforced Collagen-Based Composite Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis: Meets the 2018 International Classification of Periodontal Diseases, diagnosed with Stage III or IV periodontitis.
- Bone Defect Characteristics: At least one affected tooth presents with a deep periodontal pocket (PPD ≥5 mm), and CBCT imaging confirms the presence of significant vertical bone resorption or angular bone defects (these defect types are most suitable for in-situ hydrogel filling and guided regeneration).
- Age and General Condition: Aged between 18 and 70 years, any gender, generally in good systemic health.
- Compliance and Consent: The subject is able to understand the study procedures, voluntarily sign the informed consent form, and commit to returning for follow-up visits as required (1, 3, 6, 12 months).
Who cannot join
- Systemic Interference with Bone Metabolism: Presence of poorly controlled diabetes (HbA1c > 7%), osteoporosis, or long-term use of medications affecting bone metabolism such as bisphosphonates or glucocorticoids within the past six months.
- Local Anatomical Limitations: The affected tooth has a vertical root fracture, severe periapical pathology, or a residual root that is deemed non-restorable and without preservation value.
- Factors Interfering with Healing: Heavy smokers (average > 10 cigarettes per day), as impaired microcirculation can significantly compromise the biological effects of the hydrogel.
- Special Physiological Periods: Pregnant or breastfeeding women. Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
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
Official title: Clinical Study of Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Promoting Alveolar Bone Regeneration
Based on the mechanism of intramembranous ossification of the alveolar bone, it is necessary to design a biomimetic membrane material based on the principle of GBR (Guided Bone Regeneration) to simulate the biological microenvironment of alveolar bone regeneration, promote the direct differentiation of stem cells into osteoblasts and rapid mineralization, thereby achieving the goal of alveolar bone regeneration. This section, based on bionic principles, proposes to enhance the mechanical properties of the collagen membrane with silk fibroin to achieve synergistic regeneration of periodontal bone/soft tissue. This project employs silk fibroin-reinforced collagen membrane technology to overcome the dual bottlenecks of insufficient strength and excessively rapid degradation of existing materials; establishes a "structure-guided, mechanically supported, factor-controlled release" trinity regeneration strategy to achieve precise repair of periodontal composite tissues. This study will provide new materials and methods for periodontal regeneration and offer a theoretical reference for the combined regeneration of other hard/soft tissues.
- Conditions
- Alveolar Bone Loss* / Therapy
- Being tested
- Silk Fibroin-Reinforced Collagen-Based Composite Membrane
- Keywords
- Alveolar bone, Collagen, Silk fibroin, Membrane material
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk Fibroin-Reinforced Collagen-Based Composite MembraneOther
Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Other | Not described Receives: Other: Silk Fibroin-Reinforced Collagen-Based Composite Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Bone Defect Fill Height (VBH)
Three-dimensional reconstruction using CBCT (Cone Beam Computed Tomography) to measure the change in distance from the base of the bone defect to the alveolar crest between pre-operative and post-operative scans.
Measured: Up to 12 month
Secondary outcomes (1)
Alveolar Bone Density
Gray value calculation of the region of interest (ROI) using CBCT software.
Measured: Up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone Loss* / TherapyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjie Ren, Principal investigator, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574853
- Sponsor's protocol ID
- SFCM-2026-01
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Promoting Alveolar Bone Regeneration
- ClinicalTrials.gov ID
- NCT07574853
- Acronym / sponsor ID
- SFCM-2026-01
- Conditions
- Alveolar Bone Loss* / Therapy
- Keywords
- Alveolar bone, Collagen, Silk fibroin, Membrane material
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 May 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.
Based on the mechanism of intramembranous ossification of the alveolar bone, it is necessary to design a biomimetic membrane material based on the principle of GBR (Guided Bone Regeneration) to simulate the biological microenvironment of alveolar bone regeneration, promote the direct differentiation of stem cells into osteoblasts and rapid mineralization, thereby achieving the goal of alveolar bone regeneration. This section, based on bionic principles, proposes to enhance the mechanical properties of the collagen membrane with silk fibroin to achieve synergistic regeneration of periodontal bone/soft tissue. This project employs silk fibroin-reinforced collagen membrane technology to overcome the dual bottlenecks of insufficient strength and excessively rapid degradation of existing materials; establishes a "structure-guided, mechanically supported, factor-controlled release" trinity regeneration strategy to achieve precise repair of periodontal composite tissues. This study will provide new materials and methods for periodontal regeneration and offer a theoretical reference for the combined regeneration of other hard/soft tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | Other | Other: Silk Fibroin-Reinforced Collagen-Based Composite Membrane |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical Diagnosis: Meets the 2018 International Classification of Periodontal Diseases, diagnosed with Stage III or IV periodontitis.
- Bone Defect Characteristics: At least one affected tooth presents with a deep periodontal pocket (PPD ≥5 mm), and CBCT imaging confirms the presence of significant vertical bone resorption or angular bone defects (these defect types are most suitable for in-situ hydrogel filling and guided regeneration).
- Age and General Condition: Aged between 18 and 70 years, any gender, generally in good systemic health.
- Compliance and Consent: The subject is able to understand the study procedures, voluntarily sign the informed consent form, and commit to returning for follow-up visits as required (1, 3, 6, 12 months).
Key exclusion criteria (4 listed)
- Systemic Interference with Bone Metabolism: Presence of poorly controlled diabetes (HbA1c > 7%), osteoporosis, or long-term use of medications affecting bone metabolism such as bisphosphonates or glucocorticoids within the past six months.
- Local Anatomical Limitations: The affected tooth has a vertical root fracture, severe periapical pathology, or a residual root that is deemed non-restorable and without preservation value.
- Factors Interfering with Healing: Heavy smokers (average > 10 cigarettes per day), as impaired microcirculation can significantly compromise the biological effects of the hydrogel.
- Special Physiological Periods: Pregnant or breastfeeding women. Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
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 |
|---|---|---|
| Silk Fibroin-Reinforced Collagen-Based Composite MembraneSilk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration | Other | No treatment |
Primary outcome
Vertical Bone Defect Fill Height (VBH)
Time frame: Up to 12 month
Three-dimensional reconstruction using CBCT (Cone Beam Computed Tomography) to measure the change in distance from the base of the bone defect to the alveolar crest between pre-operative and post-operative scans.
1 secondary outcome
Alveolar Bone Density
Time frame: Up to 12 month
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 8 May 2026.
Related trials for Alveolar Bone Loss* / Therapy
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Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting
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Ultrasound for Socket Healing Evaluation
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Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
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Alveolar Bone Loss
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.
Wenjie Ren principal investigator
The First Affiliated Hospital of Xinxiang Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Silk Fibroin-Reinforced Collagen-Based Composite Membrane in people with Alveolar Bone Loss* / Therapy, run by The First Affiliated Hospital of Xinxiang Medical College.
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 4 inclusion and 4 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 8 May 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 Wenjie Ren (8613937354075, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Bone Defect Fill Height (VBH) (time frame: Up to 12 month). 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 8 May 2026.