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NCT Number: NCT07611630

Clinical Study of Minocycline Hydrochloride Injectable Hydrogel for the Treatment of Periodontitis

This study aims to construct and systematically evaluate a multifunctional synergistic drug delivery system based on a hyaluronic acid-nanoclay composite hydrogel to achieve integrated treatment of periodontitis encompassing "infection control, inflammation regulation, and bone regeneration promotion." Through material design, in vitro functional validation, and in vivo efficacy evaluation, the study will elucidate the intrinsic relationships and synergistic mechanisms among "material structure, controlled drug release, and biological effects" within this system, thereby providing a theoretical basis and experimental foundation for the development of smart periodontal regenerative materials with clinical translational potential.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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.

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.

Treatment and study plan

treatment group

Other

hyaluronic acid-nanoclay composite hydrogel (containing HA-Pam/MH@Laponite).

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

Construction of a Long-Acting Sustained-Release Minocycline Hydrochloride Delivery System Based on Hyaluronic Acid-Nanoclay Composite Hydrogel and Its Application in the Treatment of 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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