Not Yet RecruitingNot Applicable

Study on Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration

80 participantsStarted 2026-05-01

Plain-language 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 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.

Who can participate

Age range

18 Years – 70 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: * 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). Exclusion Criteria: * 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: Kno…

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

Vertical Bone Defect Fill Height (VBH)

Timeframe: Up to 12 month

Trial details

NCT IDNCT07574853

SponsorThe First Affiliated Hospital of Xinxiang Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Wenjie Ren

8613937354075 13937354075@163.com

View on ClinicalTrials.gov More Alveolar Bone Loss* / Therapy trials