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

May 3, 2026 updated by: The First Affiliated Hospital of Xinxiang Medical College

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No treatment
Other: Silk Fibroin-Reinforced Collagen-Based Composite Membrane
Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar Bone Density
Time Frame: Up to 12 month
Gray value calculation of the region of interest (ROI) using CBCT software.
Up to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Investigators

  • Principal Investigator: Wenjie Ren, The First Affiliated Hospital of Xinxiang Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

May 3, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFCM-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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