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NCT Number: NCT07611617

Clinical Study of BMP-2 Injectable Hydrogel for Promoting Alveolar Bone Regeneration

This project aims to construct an injectable self-healing hydrogel loaded with BMP-2, with optimized gelation time and mechanical strength to meet the requirements for periodontal pocket filling, for the treatment of periodontitis and acceleration of tissue repair, achieving a "bactericidal-anti-inflammatory-regenerative" trinity function. This project will provide a novel intelligent material for promoting alveolar bone regeneration in periodontitis and establish a theoretical paradigm for the precise intervention of oral infectious diseases.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treatment group

Other

subgingival scaling + BMP-2 hydrogel

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Periodontal Parameter Examination

    Time frame: Up to 12 month

    Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Gingival Recession Depth (GR), Bleeding on Probing (BOP).

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjie Ren

CONTACT

[email protected]

8613937354075

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College

Other

Registry information

Official study title

Study on Injectable Hydrogel Loaded With BMP-2 for Promoting Alveolar Bone Regeneration Induced by Periodontitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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